Phase 4 Completed N=473 Randomized Treatment

An Efficacy, Safety and Effects on Quality of Life of Tramadol/Paracetamol as Add-on Therapy in Chronic Osteoarthritis

Osteoarthritis

Source: ClinicalTrials.gov NCT01728246 ↗

Enrolled (actual)

473

Serious AEs

0.4%

Results posted

Jan 2013

Primary outcomePrimary: Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) Score at Week 2 — 71.86; 68.03; -29.721; -21.972 mm — p=<0.05

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).

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) Score at Week 2	71.86; 68.03; -29.721; -21.972	<0.05 sig
PRIMARY Change From Baseline in VAS-pain Score at Week 4	-45.027; -34.266	<0.05 sig
PRIMARY Change From Baseline in Oswestry Disability Index (ODI) Score at Week 2	—	—
PRIMARY Change From Baseline in ODI Score at Week 4	58.24; 57.23; -19.102; -15.177	<0.05 sig
PRIMARY Percentage of Participants Who Discontinued Because of Rescue Medication	0.41; 2.16	—
PRIMARY Time to Discontinuation Because of Rescue Medication	—	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01728246). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.