CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 91 enrolled
Drug / intervention
Tapentadol Hydrochloride +1 moredrug
Likely dose
Tapentadol Hydrochloride 250 milligramfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01124604
NCT01124604Phase 2Completed
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Phase II Study of JNS024ER in Japanese Subjects With Chronic Pain Due to Osteoarthritis of the Knee or Low Back Pain

Janssen Pharmaceutical K.K.·interventional·Posted May 17, 2010·Updated May 14, 2013

In Brief

A Phase 2 clinical trial evaluating Tapentadol Hydrochloride and Placebo for Pain and 3 related conditions. Completed, enrolled 91 participants across 19 sites.

Detailed Summary

The purpose of this study is to evaluate the efficacy, safety and to explore the pharmacokinetics (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time) of tapentadol hydrochloride extended release (ER) tablets in Japanese participants with moderate to severe chronic pain due to osteoarthritis (disorder in which the joints become painful and stiff) of knee or low back pain.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Low Back Pain, Back Pain, Osteoarthritis, Knee
CountriesJapan
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 17, 2010
Enrollment StartApr 1, 2010
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 16.1 years ago

Interventions

Tapentadol Hydrochloridedrug

Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) will be administered orally twice daily for 12 weeks. Dose will be adjusted as per Investigator's discretion.

Placebodrug

Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg will be administered orally twice daily for 12 weeks. Dose will be adjusted as per Investigator's discretion.