Status:
COMPLETED
A Four-Arm Study Comparing the Analgesic Efficacy and Safety of Tramadol Once a Day 100, 200 and 300 mg Versus Placebo for the Treatment of Pain Due to Osteoarthritis of the Knee
Lead Sponsor:
Labopharm Inc.
Conditions:
Pain
Osteoarthritis, Knee
Eligibility:
All Genders
40-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the analgesic efficacy and safety of Tramadol Once a Day 100, 200, 300 mg and Placebo
Eligibility Criteria
Inclusion
- Males or Females between the ages of 40-75 with a diagnosis of moderate to severe osteoarthritis of the knee, consistent with the American College of Rheumatology (ACR) Clinical Classification Criteria for Arthritis of the Knee:
- 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 five years prior to entry into the study.
- C-reactive protein (CRP) \< 8 ug/ml (if available at local lab) or erythrocyte sedimentation rate (ESR) \< 40 mm/hr
- Total WOMAC (Western Ontario and McMaster University Osteoarthritis Index) Pain Subscale Score of \> 150 mm at Baseline corresponding with moderate to severe Osteoarthritis.
- Oral and written language comprehension at a level sufficient to comply with the protocol and complete study-related materials.
- Research Ethics Board (REB) approval of the written Informed Consent Form in Spanish or English which was signed and dated by the patient and Investigator, prior to study participation.
Exclusion
- 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; or collagen gene mutations.
- Evidence of effusion greater than 15 cubic centimetre (cc) upon physical examination of the joint at Baseline (Visit 1).
- Body Mass Index (BMI) ≥ 38.
- Major illness, requiring hospitalization during the 3 months before commencement of the screening period.
- The patient was unwilling to stop taking pain medication (for arthritis or other types of pain) or was unwilling to stop taking other medications for the treatment of osteoarthritis (OA).
- Previous failure or discontinuation (due to adverse events) of tramadol hydrochloride (HCl) therapy.
- Treatment within the last 3 weeks with any of the following medications: monoamine oxidase inhibitors; tricyclic antidepressants and other tricyclic compounds (e.g. cyclobenzaprine, promethazine); neuroleptics; selective serotonin reuptake inhibitors; or any other drug that reduces seizure threshold.
- Treatment with another investigational agent within the last 30 days.
- A history of seizure disorder other than Infantile Febrile Seizures.
- Previous or current opioid dependency.
- Bowel disease causing malabsorption.
- Pregnancy or lactating or childbearing potential and unwilling to utilize a medically approved method of contraception during participation in this clinical trial.
- Significant liver disease, defined as active hepatitis or elevated liver enzymes \>3 times the upper boundary of the normal range.
- Significant renal disease, defined as creatinine clearance \<30 mL/min as estimated by the method of Levey et al., 1999.
- Current substance abuse or dependence, other than nicotine.
- Allergy or adverse reaction to tramadol or any structurally similar drugs e.g. opiates.
- Any other condition, that, in the opinion of the Investigators, would have adversely affected the patient's ability to complete the study or its measures.
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
565 Patients enrolled
Trial Details
Trial ID
NCT00832416
Start Date
January 1 2003
Last Update
April 30 2012
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