Status:
COMPLETED
A Comparison of the Analgesic Efficacy and Safety of Once Daily Tramadol HCl / Contramid® Tablets to Twice Daily Tramadol HCl (SR) for the Treatment of Osteoarthritis of the Knee
Lead Sponsor:
Labopharm Inc.
Conditions:
Osteoarthritis, Knee
Pain
Eligibility:
All Genders
40-75 years
Phase:
PHASE3
Brief Summary
A randomised, multi-centre, double-blind, double dummy, two arm parallel design study to compare the efficacy, safety, and clinical benefit of the test and reference product after treatment for 84 day...
Eligibility Criteria
Inclusion
- Males or Females between the ages of 40 and 75 with a diagnosis of Osteoarthritis (OA) of the knee consistent with the American College of Rheumatology (ACR) Clinical Classification Criteria for Arthritis of the Knee (Altman, R. et al., 1986):
- Knee pain at study enrolment,
- 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 1 year prior to entry into the study.
- ESR \< 40 mm/h
- Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Pain Subscales total score equal to or more than 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 signed and dated the (IEC) approved, written, informed consent 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; heritable arthritic disorders; or collagen gene mutations.
- Obesity Class II \[body mass index (BMI) equal to or more than 35 kg/m2\] (NIH, 2000)
- Major illness that required hospitalisation 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 had previously failed tramadol HCl therapy or those who discontinued tramadol HCl due to AEs.
- Patients who within the 3 weeks prior to study entry took 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 took another investigational agent within the 30 days prior to study entry.
- Patients with a history of seizure disorder other than Infantile Febrile Seizures.
- Patients who were opioid dependent.
- Patients with bowel disease causing malabsorption.
- Patients who were pregnant or lactating or patients of child-bearing potential who were unwilling to utilise a medically approved method of contraception during participation in this clinical trial.
- Patients with significant liver disease, defined as active hepatitis or elevated liver enzymes \>3 times the upper boundary of the normal range.
- Patients with 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, adversely affected the patient's ability to complete the study or its measures.
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2002
Estimated Enrollment :
431 Patients enrolled
Trial Details
Trial ID
NCT00950651
Start Date
March 1 2002
End Date
November 1 2002
Last Update
April 30 2012
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