Clinical trial NCT01728246: An Efficacy, Safety and Effects on Quality of Life of Tramadol/Paracetamol as Add-on Therapy in Chronic Osteoarthritis
Official title: A Randomized Controlled Trial on the Efficacy, Safety and Quality of Life Effects of Add-on Tramadol/Paracetamol Combination in Chronic Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis
Keywords: Osteoarthritis
Celecoxib
Tramadol
Paracetamol
Lead sponsor: Janssen Pharmaceutica
Sponsor class: INDUSTRY
First posted: 2012-11-19
Enrollment: 473
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed description: This is an open-label (all people know the identity of the intervention), randomized (study drug assigned by chance), controlled study to evaluate the efficacy, safety and effects on QOL of tramadol/APAP as an add-on therapy in Filipino participants suffering from chronic pain because of chronic osteoarthritis. Participants will be randomly assigned to 2 groups: tramadol/APAP group and non tramadol/APAP group. Participants in tramadol/APAP group will receive celecoxib 200 milligram (mg) and fixed dose combination of tramadol (37.5 mg)/APAP (325 mg) as add on therapy, while the participants in non-tramadol/APAP group will receive celecoxib 200 mg only. The total duration of the study will be 4 weeks. The participants in both the groups will be given celecoxib 200 mg once daily for 4 weeks. In addition, the participants in the tramadol/APAP group will be given add-on tramadol/APAP doses 3 times a day for 4 weeks. Participants will be asked to return for follow-up at Weeks 2 and 4. Efficacy will be assessed using 100 millimeter (mm) Visual Analog Scale (VAS) while QOL will be assessed using the Oswestry Disability Index (ODI). Participant safety will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with chronic osteoarthritis of knee or hip for greater than (\>) or equal to (=) 1 year (based on the American College of Rheumatology (ACR) diagnostic criteria for osteoarthritis), who are experiencing at least moderate osteoarthritis pain (\>=50 millimeter \[mm\] in 100 mm Visual Analog Scale \[VAS\])
* On any Cyclooxygenase - 2 (COX-2) inhibitors for at least 2 weeks preceding the study
* Women with childbearing potential must have negative pregnancy test
* Women of child bearing potential must agree to use accepted methods of contraception
* Participant has signed the written informed consent form

Exclusion Criteria:

* Participants taking Monoamine oxydase (MAO) inhibitors, neuroleptics or drugs for seizures
* Severe hepatic impairment (the impaired ability of the liver to fulfill its role in metabolism)
* On maintenance tramadol and/or paracetamol(APAP)
* On sedative hypnotics, short-acting analgesics, topical medications and anesthetics, and/or muscle relaxants
* Pregnant, lactating or breastfeeding participants

Primary outcomes:
measure: Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) Score at Week 2
timeFrame: Baseline and Week 2
measure: Change From Baseline in VAS-pain Score at Week 4
timeFrame: Baseline and Week 4 Last Observation Carried Forward (LOCF)
measure: Change From Baseline in Oswestry Disability Index (ODI) Score at Week 2
timeFrame: Baseline and Week 2
measure: Change From Baseline in ODI Score at Week 4
timeFrame: Baseline and Week 4 (LOCF)
measure: Percentage of Participants Who Discontinued Because of Rescue Medication
timeFrame: Baseline up to Week 4
measure: Time to Discontinuation Because of Rescue Medication
timeFrame: Baseline up to Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Paranaque City
country: Philippines
facility: Janssen Philippines
state: Metro Manila
Study officials:
affiliation: Janssen Pharmaceutica
name: Janssen Pharmaceutica Clinical trial
role: STUDY_DIRECTOR
References: