CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 80 enrolled
Drug / intervention
Tramadol hydrochloride +1 moredrug
Likely dose
Tramadol hydrochloride 37.5 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/NCT00766675
NCT00766675Phase 4Completed
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Ultracet (Tramadol HCL [37.5 mg]/Acetaminophen [325 mg]) Combination Tablets in the Treatment of the Pain of Fibromyalgia

Johnson & Johnson Taiwan Ltd·interventional·Posted Oct 6, 2008·Updated Jul 3, 2013

In Brief

A Phase 4 clinical trial evaluating Tramadol hydrochloride and Acetaminophen for Pain and Fibromyalgia. Completed, enrolled 80 participants.

Detailed Summary

The purpose of this study is to evaluate the analgesic effect of combination of tramadol hydrochloride and acetaminophen in participants for treatment of fibromyalgia pain (chronic widespread pain and presence of tender points).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Fibromyalgia
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 6, 2008
Enrollment StartOct 1, 2008
Primary CompletionMar 1, 2009
Study CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 17.7 years ago

Interventions

Tramadol hydrochloridedrug

Tramadol hydrochloride oral tablet will be administered at a dose of 37.5 milligram as, once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.

Acetaminophendrug

Acetaminophen oral tablet will be administered at a dose of 325 milligram as, once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.