A Comparison of the Analgesic Efficacy and Safety of Once Daily Tramadol OAD Tablets to Twice Daily Tramadol BID for the Treatment of Osteoarthritis of the Knee (Extension Protocol) and Open Label Safety Follow-Up

Labopharm Inc.0 sites238 target enrollmentMarch 2002

ConditionsPain Osteoarthritis, Knee

InterventionsTramadol OAD Tramadol OAD 100mg

DrugsTramadol OAD Tramadol OAD 100mg

Overview

Phase: Phase 3
Intervention: Tramadol OAD
Conditions: Pain
Sponsor: Labopharm Inc.
Enrollment: 238
Primary Endpoint: Adverse Events: 12-months Safety Population
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 evaluate the long-term safety (up to one year) of Tramadol Once-A-Day (OAD) tablets at the highest doses: 200-400 mg

Registry

clinicaltrials.gov

Start Date

March 2002

End Date

July 2003

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

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 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 one year prior to entry into the study.
•ESR \< 40 mm/hour
•WOMAC Pain Subscales total score of more than or equal to 150 mm at baseline.
•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 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 (BMI more than or equal to 35) (NIH, 2000)
•Major illness requiring hospitalization during the 3 months before commencement of the screening period.
•Unwillingness to cease taking medication other than the study medication for arthritic pain, any other concomitant pain, or OA medications.
•Patients who have previously failed tramadol 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 OAD 200mg

Intervention: Tramadol OAD

Tramadol OAD 300mg

Intervention: Tramadol OAD

Tramadol OAD 400mg

Intervention: Tramadol OAD

Tramadol OAD 100mg

Despite provision in the protocol that the minimum daily dose was 200 mg, 2 patients took 100 mg against instructions.

Intervention: Tramadol OAD 100mg

Outcomes

Primary Outcomes

Adverse Events: 12-months Safety Population

Time Frame: 12 months

Spontaneous adverse events were recorded for patients who received the same dose for at least 350 days. A treatment emergent adverse event (TEAE) was associated to the dose level on which a patient was 2 days prior to the TEAE. Only TEAEs which could be associated with the dose level on which the patient was for the longest time were considered.