CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 78 enrolled
Drug / intervention
Tapentadol PRdrug
Likely dose
Tapentadol PR 25 mgfrom 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/NCT00805142
NCT00805142Phase 2Completed
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Phase II Study of JNS024PR in Cancer Pain Patients

Janssen Pharmaceutical K.K.·interventional·Posted Dec 9, 2008·Updated Jul 29, 2013

In Brief

A Phase 2 clinical trial evaluating Tapentadol PR for Pain and Cancer. Completed, enrolled 78 participants across 21 sites.

Detailed Summary

The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics (how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time; explores what the body does to the drug) of tapentadol prolonged release (JNS024PR, PR) in participants with moderate to severe cancer (abnormal tissue that grows and spreads in the body until it kills) pain.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Cancer
CountriesJapan
CollaboratorsGrünenthal GmbH

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 9, 2008
Enrollment StartNov 1, 2008
Primary CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 17.6 years ago

Interventions

Tapentadol PRdrug

Tapentadol PR tablets will be administered orally twice daily initiated at dose of 25 mg. Dose will be adjusted as per Investigator's discretion. Maximum dose limit is 500 mg per day. Total duration of treatment is 19 days.