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<p>ClinicalTrials.gov is a service of the</p> <p>National Institutes of Health.</p> <p>Parallel Study Design Example 10 of 11 September 4, 2014</p> <p>(With Results)</p> <p>Adverse Events</p> <p>Reporting Groups</p> <p>Description</p> <p>Remuverol Participants received Remuverol 15 mg tablet orally twice daily for 24 weeks.</p> <p>Placebo Participants received Remuverol placebo tablet orally twice daily for 24 weeks.</p> <p>Serious Adverse Events</p> <p># Participants Affected/At Risk</p> <p>Remuverol Placebo</p> <p>Total, serious adverse events 4/101 (3.96%) 0/99 (0%)</p> <p>Blood and lymphatic system disorders</p> <p>Anemia Iron Deficiency † 1 1/101 (0.99%) 0/99 (0%)</p> <p>Idiopathic Thrombocytopenic Purpura † 1 1/101 (0.99%) 0/99 (0%)</p> <p>Immune system disorders</p> <p>Viral Meningitis † 1 1/101 (0.99%) 0/99 (0%)</p> <p>Skin and subcutaneous tissue disorders</p> <p>Psoriasis † 1 1/101 (0.99%) 0/99 (0%)</p> <p>† Indicates events were collected by systematic assessment.</p> <p>1 Term from vocabulary, MedDRA (12.0)</p> <p>Other Adverse Events</p> <p>Frequency Threshold</p> <p>Threshold above which other adverse events are reported: 1%</p> <p># Participants Affected/At Risk</p> <p>Remuverol Placebo</p> <p>Total, other (not including serious) adverse</p> <p>events 98/101 (97.03%) 46/99 (46.46%)</p> <p>Ear and labyrinth disorders</p> <p>Earache † 1 35/101 (34.65%) 7/99 (7.07%)</p> <p>Endocrine disorders</p> <p>Hypothyroidism † 1 27/101 (26.73%) 25/99 (25.25%)</p> <p>Eye <disorders></p> <p>Conjunctivitis † 1 13/101 (12.87%) 4/99 (4.04%)</p> <p>Gastrointestinal disorders</p> <p>Nausea † 1 12/101 (11.88%) 7/99 (7.07%)</p> <p>Stomachache † 1 10/101 (9.9%) 2/99 (2.02%)</p> <p>Vomiting † 1 10/101 (9.9%) 3/99 (3.03%)</p> <p>† Indicates events were collected by systematic assessment.</p> <p>1 Term from vocabulary, MedDRA (12.0)</p> <p>ClinicalTrials.gov is a service of the</p> <p>National Institutes of Health.</p> <p>Parallel Study Design Example 11 of 11 September 4, 2014</p> <p>(With Results)</p> <p>More Information</p> <p>Certain Agreements</p> <p>All Principal Investigators ARE employed by the organization sponsoring the study.</p> <p>Limitations and Caveats (Limitations of the study, such as early termination leading to small numbers of</p> <p>subjects analyzed and technical problems with measurement leading to unreliable or uninterpretable data.)</p> <p>[No text entered.]</p> <p>Results <Point> of Contact</p> <p>Name/Official Title: PRS Training Lead</p> <p>Organization: PRS Results Training</p> <p>Phone: 555-555-5555</p> <p>Email: register@clinicaltrials.gov</p> ClinicalTrials.gov is a service of the National Institutes of Health. Parallel Study Design Example 1 of 11 September 4, 2014 (With Results) Parallel Study Design Example (With Results) This study has been completed. Sponsor: PRS Results Training Information provided by (Responsible Party): PRS Results Training Disclaimer: The following information is fictional and is only intended for the purpose of illustrating key concepts for results data entry in the Protocol Registration and Results System (PRS). Full Text View Purpose The purpose of this study is to assess the safety and efficacy of Remuverol for treatment of Condition A. Condition Intervention Phase Condition A Drug: Remuverol Phase 3 Drug: Placebo Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment Official Title: A 24-Week Double-Blind Trial of Remuverol in Adults With Condition A Further study details as provided by PRS Results Training Primary Outcome Measure: • Change From Baseline in Pain on the 11-point Short Pain Scale (SPS-11) at Week 24 [Time Frame: Baseline and Week 24] [Designated as safety issue: No] SPS-11 is a validated, self-reported instrument assessing average pain intensity over the past 24 hour period. Possible scores range from 0 (no pain) to 10 (worst possible pain). Change = (Week 24 Score - Baseline score) Secondary Outcome Measures: • Response Rate - 50 Percent or Greater Reduction in Short Pain Scale (SPS-11) Score [Time Frame: 12 weeks] [Designated as safety issue: No] The response rate was defined as the number of participants with a 50% or greater reduction in SPS-11 pain score from baseline to endpoint. SPS-11 is a validated, self-reported instrument. Possible scores range from 0 (no pain) to 10 (worst possible pain). ClinicalTrials.gov is a service of the National Institutes of Health. Parallel Study Design Example 2 of 11 September 4, 2014 (With Results) • Response Rate - 50 Percent or Greater Reduction in Short Pain Scale (SPS-11) Score [Time Frame: 24 weeks] [Designated as safety issue: No] The response rate was defined as the number of participants with a 50% or greater reduction in SPS-11 pain score from baseline to endpoint. SPS-11 is a validated, self-reported instrument. Possible scores range from 0 (no pain) to 10 (worst possible pain). • Response Rate - 75 Percent or Greater Reduction in Short Pain Scale (SPS-11) Score [Time Frame: 24 weeks] [Designated as safety issue: No] The response rate was defined as the number of participants with a 75% or greater reduction in SPS-11 pain score from baseline to endpoint. SPS-11 is a validated, self-reported instrument. Possible scores range from 0 (no pain) to 10 (worst possible pain). Enrollment: 200 Study Start Date: March 2010 Study Completion Date: August 2011 Primary Completion Date: August 2011 Arms Assigned Interventions Experimental: Remuverol Participants received Remuverol 15 mg tablet orally twice daily for 24 weeks. Drug: Remuverol 15 mg tablet Placebo Comparator: Placebo Participants received Remuverol placebo tablet matching Remuverol orally twice daily for 24 weeks. Drug: Placebo Remuverol placebo tablet Detailed Description After being informed about the study and potential risks, all patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to Remuverol (15 mg, twice daily) or placebo (twice daily). Eligibility Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Both Accepts Healthy Volunteers: No Inclusion Criteria • Outpatients • At least 18 years of age • Had Condition A for at least 6 months before the study. Condition A was diagnosed based on medical history and neurological examination. • A sufficient level of education to understand study procedures and be able to communicate with site personnel ClinicalTrials.gov is a service of the National Institutes of Health. Parallel Study Design Example 3 of 11 September 4, 2014 (With Results) Exclusion Criteria • Any cardiovascular, hepatic, or renal conditions that would compromise participation (e.g., hospitalization during the study), in the opinion of the investigator • History of acute liver injury (e.g., hepatitis) or severe cirrhosis • Body Mass Index (BMI) of >40 kg/m^2 • Pregnancy • Breast-feeding • Daily use of non-steroidal anti-inflammatory drugs (NSAIDs) or acetaminophen • Current use of narcotics Contacts and Locations Locations United States, Maryland Bethesda, Maryland, United States Canada, Quebec Montreal, Quebec, Canada Mexico Cozumel, Mexico More Information Responsible Party: PRS Results Training Study ID Numbers: TTTParallelR Health Authority: United States: Food and Drug Administration Study Results Participant Flow Recruitment Details (Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations.) Participants were recruited based on physician referral at 3 academic medical centers between February 2010 and January 2011. The first participant was enrolled in March 2010, and the last participant was enrolled in December 2010. ClinicalTrials.gov is a service of the National Institutes of Health. Parallel Study Design Example 4 of 11 September 4, 2014 (With Results) Reporting Groups Description Remuverol Participants received Remuverol 15 mg tablet orally twice daily for 24 weeks. Placebo Participants received Remuverol placebo tablet orally twice daily for 24 weeks. Overall Study Number of Participants Remuverol Placebo STARTED 101 99 Per Protocol Population Week 12 98 95 Per Protocol Population Week 24 76 81 COMPLETED 80 81 Not Completed 21 18 Adverse Event 10 8 Withdrawal by Subject 5 4 Protocol Violation 2 2 Lack of Efficacy 1 1 Physician Decision 1 1 Lost to Follow-up 1 2 Pregnancy 1 0 Baseline Characteristics Analysis Population Description (Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.) [No text entered.] Reporting Groups Description Remuverol Participants received Remuverol 15 mg tablet orally twice daily for 24 weeks. Placebo Participants received Remuverol placebo tablet orally twice daily for 24 weeks. ClinicalTrials.gov is a service of the National Institutes of Health. Parallel Study Design Example 5 of 11 September 4, 2014 (With Results) Baseline Measures Remuverol Placebo Total Number of Participants [units: participants] 101 99 200 Age Continuous [units: years] Mean ± Standard Deviation 34.78 ± 9.72 35.34 ± 10.71 34.98 ± 9.89 Gender, Male/Female [units: participants] Female 60 63 123 Male 41 36 77 Race/Ethnicity, Customized [units: participants] African 5 4 9 Caucasian 90 90 180 Hispanic 5 4 9 Native American 1 1 2 Region of Enrollment [units: participants] United States 44 47 91 Canada 35 35 70 Mexico 22 17 39 Quebec Task Force Classification of Spinal Disorders [units: participants] Class 0 (no pain) 16 14 30 Class 1 (pain without radiation) 73 68 141 Class 2 (pain with proximal extremity radiation) 12 17 29 Body Mass Index [units: kg/m^2] Mean ± Standard Deviation 26.65 ± 4.50 27.41 ± 4.72 26.91 ± 4.55 Short Pain Scale (SPS-11) Score [units: units on a scale] Mean ± Standard Deviation 6.48 ± 1.34 6.57 ± 1.73 6.52 ± 1.61 Duration of Condition A [units: years] Mean ± Standard Deviation 3.82 ± 3.18 3.47 ± 2.95 3.75 ± 3.06 Height [units: cm] Mean ± Standard Deviation 186.42 ± 9.46 176.91 ± 8.28 181.33 ± 8.95 Weight [units: kg] Mean ± Standard Deviation 77.03 ± 14.38 78.53 ± 13.56 77.98 ± 13.79 Quebec Task Force (QTF) Classification of Spinal Disorders consists of 8 classes ranging from Class 0 (no pain) to Class 7 (spinal stenosis). SPS-11 is a validated, self-reported instrument assessing average pain intensity over the past 24 hr period. The severity of pain on the SPS-11 ranges from 0 (no pain) to 10 (worst possible pain). ClinicalTrials.gov is a service of the National Institutes of Health. Parallel Study Design Example 6 of 11 September 4, 2014 (With Results) Outcome Measures 1. Primary Outcome Measure Measure Title Change From Baseline in Pain on the 11-point Short Pain Scale (SPS-11) at Week 24 Measure Description SPS-11 is a validated, self-reported instrument assessing average pain intensity over the past 24 hour period. Possible scores range from 0 (no pain) to 10 (worst possible pain). Change = (Week 24 Score – Baseline score) Time Frame Baseline and Week 24 Safety Issue No Analysis Population Description (Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.) Intent to treat population (all participants who received at least one dose of intervention). Last observation carried forward (LOCF) imputation method. Reporting Groups Description Remuverol Participants received Remuverol 15 mg tablet orally twice daily for 24 weeks. Placebo Participants received Remuverol placebo tablet orally twice daily for 24 weeks. Measured Values Remuverol Placebo Number of Participants Analyzed 101 99 Change From Baseline in Pain on the 11-point Short Pain Scale (SPS-11) at Week 24 [units: units on a scale] Mean ± Standard Error -3.84 ± 0.61 -2.08 ± 0.51 Statistical Analysis 1 for Change From Baseline in Pain on the 11-point Short Pain Scale (SPS-11) at Week 24 Groups Remuverol, Placebo Method Mixed Models Analysis P-Value 0.002 Additional details about the analysis, such as null hypothesis and power calculation: It was calculated that 200 participants randomized in a 1:1 fashion between the 2 arms would have at least 85% power to detect a difference of 0.56 points in mean SPS-11 pain score between Remuverol and placebo from baseline to week 24. Sample size was determined using a 2-sided 2-sample t test (α = 0.05). Assumptions included a common standard deviation of 1.14 and a discontinuation rate of 7%. ClinicalTrials.gov is a service of the National Institutes of Health. Parallel Study Design Example 7 of 11 September 4, 2014 (With Results) 2. Secondary Outcome Measure Measure Title Response Rate - 50 Percent or Greater Reduction in Short Pain Scale (SPS-11) Score Measure Description The response rate was defined as the number of participants with a 50% or greater reduction in SPS-11 pain score from baseline to endpoint. SPS-11 is a validated, selfreported instrument. Possible scores range from 0 (no pain) to 10 (worst possible pain). Time Frame 12 weeks Safety Issue No Analysis Population Description (Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.) Based on the per-protocol population. All participants with baseline and week 12 pain scores available. Reporting Groups Description Remuverol Participants received Remuverol 15 mg tablet orally twice daily for 24 weeks. Placebo Participants received Remuverol placebo tablet orally twice daily for 24 weeks. Measured Values Remuverol Placebo Number of Participants Analyzed 98 95 Response Rate - 50 Percent or Greater Reduction in Short Pain Scale (SPS-11) Score [units: participants] 45 41 Statistical Analysis 1 for Response Rate - 50 Percent or Greater Reduction in Short Pain Scale (SPS-11) Score Groups Remuverol, Placebo Method Fisher Exact P-Value 0.352 ClinicalTrials.gov is a service of the National Institutes of Health. Parallel Study Design Example 8 of 11 September 4, 2014 (With Results) 3. Secondary Outcome Measure Measure Title Response Rate - 50 Percent or Greater Reduction in Short Pain Scale (SPS-11) Score Measure Description The response rate was defined as the number of participants with a 50% or greater reduction in SPS-11 pain score from baseline to endpoint. SPS-11 is a validated, selfreported instrument. Possible scores range from 0 (no pain) to 10 (worst possible pain). Time Frame 24 weeks Safety Issue No Analysis Population Description (Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.) Based on the per-protocol population. All participants with baseline and week 24 pain scores available. Reporting Groups Description Remuverol Participants received Remuverol 15 mg tablet orally twice daily for 24 weeks. Placebo Participants received Remuverol placebo tablet orally twice daily for 24 weeks. Measured Values Remuverol Placebo Number of Participants Analyzed 76 81 Response Rate - 50 Percent or Greater Reduction in Short Pain Scale (SPS-11) Score [units: participants] 73 52 Statistical Analysis 1 for Response Rate - 50 Percent or Greater Reduction in Short Pain Scale (SPS-11) Score Groups Remuverol, Placebo Method Fisher Exact P-Value 0.008 ClinicalTrials.gov is a service of the National Institutes of Health. Parallel Study Design Example 9 of 11 September 4, 2014 (With Results) 4. Secondary Outcome Measure Measure Title Response Rate - 75 Percent or Greater Reduction in Short Pain Scale (SPS-11) Score Measure Description The response rate was defined as the number of participants with a 75% or greater reduction in SPS-11 pain score from baseline to endpoint. SPS-11 is a validated, selfreported instrument. Possible scores range from 0 (no pain) to 10 (worst possible pain). Time Frame 24 weeks Safety Issue No Analysis Population Description (Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.) Based on the per-protocol population. All participants with baseline and week 24 pain scores available. Reporting Groups Description Remuverol Participants received Remuverol 15 mg tablet orally twice daily for 24 weeks. Placebo Participants received Remuverol placebo tablet orally twice daily for 24 weeks. Measured Values Remuverol Placebo Number of Participants Analyzed 76 81 Response Rate - 75 Percent or Greater Reduction in Short Pain Scale (SPS-11) Score [units: participants] 57 32 Statistical Analysis 1 for Response Rate - 75 Percent or Greater Reduction in Short Pain Scale (SPS-11) Score Groups Remuverol, Placebo Method Fisher Exact P-Value 0.006 ClinicalTrials.gov is a service of the National Institutes of Health. Parallel Study Design Example 10 of 11 September 4, 2014 (With Results) Adverse Events Reporting Groups Description Remuverol Participants received Remuverol 15 mg tablet orally twice daily for 24 weeks. Placebo Participants received Remuverol placebo tablet orally twice daily for 24 weeks. Serious Adverse Events # Participants Affected/At Risk Remuverol Placebo Total, serious adverse events 4/101 (3.96%) 0/99 (0%) Blood and lymphatic system disorders Anemia Iron Deficiency † 1 1/101 (0.99%) 0/99 (0%) Idiopathic Thrombocytopenic Purpura † 1 1/101 (0.99%) 0/99 (0%) Immune system disorders Viral Meningitis † 1 1/101 (0.99%) 0/99 (0%) Skin and subcutaneous tissue disorders Psoriasis † 1 1/101 (0.99%) 0/99 (0%) † Indicates events were collected by systematic assessment. 1 Term from vocabulary, MedDRA (12.0) Other Adverse Events Frequency Threshold Threshold above which other adverse events are reported: 1% # Participants Affected/At Risk Remuverol Placebo Total, other (not including serious) adverse events 98/101 (97.03%) 46/99 (46.46%) Ear and labyrinth disorders Earache † 1 35/101 (34.65%) 7/99 (7.07%) Endocrine disorders Hypothyroidism † 1 27/101 (26.73%) 25/99 (25.25%) Eye <disorders> Conjunctivitis † 1 13/101 (12.87%) 4/99 (4.04%) Gastrointestinal disorders Nausea † 1 12/101 (11.88%) 7/99 (7.07%) Stomachache † 1 10/101 (9.9%) 2/99 (2.02%) Vomiting † 1 10/101 (9.9%) 3/99 (3.03%) † Indicates events were collected by systematic assessment. 1 Term from vocabulary, MedDRA (12.0) ClinicalTrials.gov is a service of the National Institutes of Health. Parallel Study Design Example 11 of 11 September 4, 2014 (With Results) More Information Certain Agreements All Principal Investigators ARE employed by the organization sponsoring the study. Limitations and Caveats (Limitations of the study, such as early termination leading to small numbers of subjects analyzed and technical problems with measurement leading to unreliable or uninterpretable data.) [No text entered.] Results <Point> of Contact Name/Official Title: PRS Training Lead Organization: PRS Results Training Phone: 555-555-5555 Email: register@clinicaltrials.gov <div style="clear:both; padding-bottom:0.25em"></div>
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