An Open-Label Long-term Safety Study of Tramadol HCl OAD (Once A Day) 300 mg in the Treatment of Pain Due to Osteoarthritis of the Knee

Labopharm Inc.0 sites392 target enrollmentApril 2003

ConditionsOsteoarthritis, Knee

InterventionsTramadol Once A Day

DrugsTramadol Once A Day

Overview

Phase: Phase 3
Intervention: Tramadol Once A Day
Conditions: Osteoarthritis, Knee
Sponsor: Labopharm Inc.
Enrollment: 392
Primary Endpoint: Number of Patients Having Experienced an Adverse Event During the 6-12 Month Open-Label Safety Participation
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to collect information regarding the long-term (6 and 12 months) safety of Tramadol HCl Once-A-Day(OAD) 300 mg.

Registry

clinicaltrials.gov

Start Date

April 2003

End Date

July 2004

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Labopharm Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or Female patients between the ages of 40-75 with a diagnosis of Osteoarthritis of the knee consistent with the American College of Rheumatology (ACR) Clinical Classification Criteria for Arthritis of the Knee (Altman, R. et al., 1991):
•Current knee pain,
•Less than 30 minutes of morning stiffness with or without crepitus on active motion,
•Confirmation either by arthroscopy or radiologist's report (X-rays showing osteophytes, joint space narrowing or subchondral bone sclerosis {eburnation}) within two years prior to entry into the study.
•Erythrocyte Sedimentation Rate (ESR) \< 40 mm/hour.
•Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale total score of \>= 150 mm at baseline. (5 questions/100 mm scale each with an averaged response of 30 mm or higher per question).
•Oral and written language comprehension at a level sufficient to comply with the protocol and complete study-related materials.
•The Patient has signed and dated the Research Ethics Board (REB) approved, written, informed consent prior to study participation.

Exclusion Criteria

•Known rheumatoid arthritis or any other rheumatoid disease.
•Secondary arthritis i.e. any of the following: septic arthritis; inflammatory joint disease; gout; pseudogout; Paget's disease; joint fracture; acromegaly; fibromyalgia; Wilson's disease; Ochronosis; Haemochromatosis; Osteochondromatosis; heritable arthritic disorders; or collagen gene mutations.
•Obesity Class II (Body Mass Index (BMI) \>= 35) (National Institutes of Health (NIH), 2000).
•Major illness requiring hospitalization during the 3 months before commencement of the screening period.
•Patients who are unwilling to stop taking pain medication other than the study medication (for arthritis or other types of pain) or are unwilling to stop taking other medications for the treatment of osteoarthritis (OA).
•Patients who have previously failed tramadol hydrochloride (HCl) therapy or those who discontinued tramadol HCl due to adverse events.
•Patients who are taking or within the last 3 weeks have taken the following medications: monoamine oxidase inhibitors; tricyclic antidepressants and other tricyclic compounds (e.g. cyclobenzaprine, promethazine); neuroleptics; selective serotonin reuptake inhibitors; or other drugs which reduce seizure threshold.
•Patients who are taking or have taken another investigational agent within the last 30 days.
•Patients with a history of seizure disorder other than Infantile Febrile Seizures.
•Patients who are opioid dependent.

Arms & Interventions

Tramadol Contramid® OAD

Intervention: Tramadol Once A Day

Outcomes

Primary Outcomes

Number of Patients Having Experienced an Adverse Event During the 6-12 Month Open-Label Safety Participation

Time Frame: 6 months and 12 months

Spontaneous reports of adverse events were recorded for the entire study population, the 6-months safety population and the 12-months safety population