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

NCT00832416 | Completed Phase 3 Results

• 2 other identifiers: MDT3-002NCT00832416
• Study Type: interventional
• Target: 565
• Locations: 0 countries
• Sites: N/A

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

Conditions

Pain; Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (3)

• Patient Global Rating of Pain for the Study Period (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.

  12 weeks

• Percentage Difference Between WOMAC Pain Subscale Score From Baseline to the End of the Study (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.

  Baseline to week 12

• Percentage Difference Between WOMAC Physical Function Subscale Score From Baseline to the End of the Study (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.

  Baseline to week 12

Secondary Outcomes (5)

• 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

Study Arms (4)

1 Tramadol Once A Day 100mg

EXPERIMENTAL

Drug: Tramadol Once A Day

2: Tramadol Once A Day 200mg

EXPERIMENTAL

Drug: Tramadol Once A Day

3: Tramadol Once A Day 300mg

EXPERIMENTAL

Drug: Tramadol Once A Day

4: Placebo

EXPERIMENTAL

Drug: Placebo

Interventions

Tramadol Once A Day DRUG

One Tramadol Once A Day tablet at randomized dose daily.

1 Tramadol Once A Day 100mg; 2: Tramadol Once A Day 200mg; 3: Tramadol Once A Day 300mg

Placebo DRUG

One Placebo tablet daily.

4: Placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Labopharm Inc.: lead

Related Links

• Approved labelling

MeSH Terms

Conditions

Pain; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Director of Regulatory Affairs
• Organization: Labopharm Inc.

1 450 686 1017

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2009
• First Posted: January 30, 2009
• Study Start: January 1, 2003
• Primary Completion: August 1, 2003
• Last Updated: April 30, 2012
• Results First Posted: August 3, 2009

Record last verified: 2012-04