A study of JNS020QD in patients with chronic pain (clinicaltrials.gov) - Feb 27, 2012 - P3, N=77; Recruiting -> Active, not recruiting; N=60 -> 77
Enrollment closed • Pain
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This study is ongoing, but not recruiting participants.
First Received on December 8, 2011. Last Updated on February 27, 2012 History of ChangesSponsor:Janssen Pharmaceutical K.K.Information provided by:Janssen Pharmaceutical K.K.ClinicalTrials.gov Identifier:NCT01493245 PurposeThe purpose of this study is to evaluate the efficacy and safety of JNS020QD in patients with moderate to severe chronic pain who switched from opioidanalgesics, as well as the safety and efficacy of long-term treatment (52 weeks) after switching to JNS020QD.
Condition
Chronic Pain
Intervention
Drug: JNS020QD
Phase
Phase III
Study Type:InterventionalStudy Design:Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: TreatmentOfficial Title:A Phase 3 Study of JNS020QD in Patients With Chronic Pain
Further study details as provided by Janssen Pharmaceutical K.K.:
Primary Outcome Measures:Proportion of patients who maintained the adequate analgesia [ Time Frame: At Week 4 ] [ Designated as safety issue: No ]Criteria for maintenance of adequate analgesia is defined as: 1) The daily dose of the study drug is constant during the 7 days in the maintenance period before completion of the maintenance period; 2) Change in Visual Analogue Scale (VAS) mean values from baseline to endpoint is ≤+15 mm; 3) Frequency of daily rescue doses during the 7 days in the maintenance period is ≤ 2 doses, and the change in the mean frequency of daily rescue dose from the baseline to endpoint is ≤+1.0 dose.
Secondary Outcome Measures:Proportion of patients who achieve dose-adjustment [ Time Frame: Days 19-21 ] [ Designated as safety issue: No ]Criteria for achievement of dose-adjustment is defined as: 1) The daily dose of the study drug is constant during the 3 days before completion of the titration period; 2) Change in Visual Analogue Scale (VAS) mean values from baseline to endpoint is ≤+15 mm; 3) Frequency of daily rescue doses during the 3 days in the titration period is ≤2 doses; 4) daily doses of the study drug during the titration period does not exceed the maximum doses stipulated by the investigators.
Enrollment:77
Study Start Date:August 2011
Estimated Study Completion Date:January 2013
Estimated Primary Completion Date:January 2013 (Final data collection date for primary outcome measure)
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