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 (With 7-Day Follow-up)
Overview
- Phase
- Phase 3
- Intervention
- Tramadol Once A Day
- Conditions
- Pain
- Sponsor
- Labopharm Inc.
- Enrollment
- 552
- Primary Endpoint
- Patient Global Rating of Pain for the Study Period (12 Weeks)
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
The objective 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 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.
- •CRP \< 8 ug/mL (if available at local lab) or 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.
- •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 cc upon physical examination of the joint at Baseline (Visit 1).
- •BMI greater than or equal to
- •Major illness, requiring hospitalization during the 3 months before commencement of the screening period.
- •Unwillingness to stop taking pain medication (for arthritis or other types of pain) or was unwilling to stop taking other medications for the treatment of OA.
- •Previous failure or discontinuation (due to adverse events) of tramadol 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
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
4: Placebo
Intervention: Placebo
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: 12 weeks
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 (VAS) ranging from no pain (0mm) to extreme pain (100mm). The WOMAC Pain Subscale results from the sum of 5 of the questions.
Percentage Difference Between WOMAC Physical Function Subscale Score From Baseline to the End of the Study (Week 12)
Time Frame: 12 weeks
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 difficulty (0mm) to extreme difficulty (100mm). The WOMAC Physical Function subscale results from the sum of 17 of the questions.
Secondary Outcomes
- Percentage Change in WOMAC Pain Subscale Score From Baseline to Intervening Visits (Visits 2-4)(Week 0, week 3, week 6)
- Percentage Change 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)
- Dropout Rate(12 weeks)