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
Overview
- Phase
- Phase 3
- Intervention
- Placebo
- Conditions
- Pain
- Sponsor
- Labopharm Inc.
- Enrollment
- 565
- Primary Endpoint
- Patient Global Rating of Pain for the Study Period (12 Weeks)
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 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; 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) ≥
- •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.
Arms & Interventions
4: Placebo
Intervention: Placebo
1 Tramadol Once A Day 100mg
Intervention: Tramadol Once A Day
2: Tramadol Once A Day 200mg
Intervention: Tramadol Once A Day
3: Tramadol Once A Day 300mg
Intervention: Tramadol Once A Day
Outcomes
Primary Outcomes
Patient Global Rating of Pain for the Study Period (12 Weeks)
Time Frame: 12 weeks
3-item Likert-scale: "How do you rate overall pain relief with the drug?" with 3 possible answers: "very effective", "effective", or "ineffective". The average of ratings at visits 2-5 was calculated as median, rounded up to the closest integer.
Percentage Difference Between WOMAC Pain Subscale Score From Baseline to the End of the Study (Week 12)
Time Frame: Baseline to week 12
Percentage of difference in WOMAC Pain Subscale score between baseline and week 12. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 100mm visual analog scale ranging from no pain (0mm) to extreme pain (100mm). The WOMAC Pain Subscale results from the sum of 5 questions.
Percentage Difference Between WOMAC Physical Function Subscale Score From Baseline to the End of the Study (Week 12)
Time Frame: Baseline to week 12
Percentage of difference in WOMAC Physical Function Subscale score between baseline and week 12. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 100mm visual analog scale ranging from no pain (0mm) to extreme pain (100mm). The WOMAC Physical Function subscale results from the sum of 17 questions.
Secondary Outcomes
- Percentage Difference in WOMAC Pain Subscale Score From Baseline to Intervening Visits (Visits 2-4)(Week 0, week 3, week 6)
- Percentage Difference in WOMAC Physical Function Subscale Score From Baseline to Intervening Visits (Visits 2-4)(Week 0, week 3, week 6)
- Multiple Dose Effect Using 24-hour VAS Pain Questionnaire(12 weeks)
- Investigator Global Rating of Pain Relief(12 weeks)
- Percentage of Participants Who Dropped Out From Trial by Dropout Reason(12 weeks)