A Study of JNS020QD in Patients With Chronic Pain
|ClinicalTrials.gov Identifier: NCT01493245|
Recruitment Status : Completed
First Posted : December 15, 2011
Last Update Posted : March 24, 2014
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain||Drug: JNS020QD||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||77 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3 Study of JNS020QD in Patients With Chronic Pain|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
During weeks 1-3, initial doses of 0.84 mg, 1.7 mg, 3.4 mg, or 5 mg can be increased until individual optimal dose (up to maximum 20.1 mg) is determined. The optimal dose will be administered during the maintenance period (1 week), followed by a long-term treatment (48 weeks) period, where the dose will be adjusted (escalated or reduced) in consideration of the efficacy of the study, and the condition of adverse events. The patches are applied on the skin and exchanged daily (every 24 hours) for consecutive 52 weeks.
- Proportion of patients who maintained the adequate analgesia [ Time Frame: At Week 4 ]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.
- Proportion of patients who achieve dose-adjustment [ Time Frame: Days 19-21 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01493245
|Kawasaki N/A, Japan|
|Study Director:||Janssen Pharmaceutical K.K., Japan Clinical Trial||Janssen Pharmaceutical K.K.|