CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 473 enrolled
Drug / intervention
Tramadol/Paracetamol (APAP) +1 moredrug
Likely dose
Tramadol/Paracetamol (APAP) 200 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/NCT01728246
NCT01728246Phase 4Completed
CompareCT.gov

A Randomized Controlled Trial on the Efficacy, Safety and Quality of Life Effects of Add-on Tramadol/Paracetamol Combination in Chronic Osteoarthritis

Janssen Pharmaceutica·interventional·Posted Nov 19, 2012·Updated Feb 12, 2013

In Brief

A Phase 4 clinical trial evaluating Tramadol/Paracetamol (APAP) and Non-Tramadol/APAP for Osteoarthritis. Completed, enrolled 473 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate the efficacy, safety and effects on Quality of Life (QOL) of tramadol/paracetamol (APAP) as an add-on therapy (medication taken in addition to another medication) in Filipino participants with chronic (lasting a long time) osteoarthritis (disorder, which is seen mostly in older persons, in which the joints become painful and stiff).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis
CountriesPhilippines
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 19, 2012
Enrollment StartOct 1, 2007
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 13.6 years ago

Interventions

Tramadol/Paracetamol (APAP)drug

Celecoxib 200 milligram (mg) once daily for 4 weeks and fixed dose combination of Tramadol 37.5 mg/Paracetamol 325 mg thrice daily for 4 weeks as add-on therapy.

Non-Tramadol/APAPdrug

Celecoxib 200 mg alone once daily for 4 weeks.