- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00832416
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
April 25, 2012 updated by: Labopharm Inc.
The purpose of this study is to compare the analgesic efficacy and safety of Tramadol Once a Day 100, 200, 300 mg and Placebo
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
565
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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) ≥ 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 2: Tramadol Once A Day 200mg
|
One Tramadol Once A Day tablet at randomized dose daily.
|
Experimental: 3: Tramadol Once A Day 300mg
|
One Tramadol Once A Day tablet at randomized dose daily.
|
Experimental: 1 Tramadol Once A Day 100mg
|
One Tramadol Once A Day tablet at randomized dose daily.
|
Experimental: 4: Placebo
|
One Placebo tablet daily.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 weeks
|
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.
|
Baseline to week 12
|
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.
|
Baseline to week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Multiple Dose Effect Using 24-hour VAS Pain Questionnaire
Time Frame: 12 weeks
|
Patients rated their knee pain by marking a 100mm Visual Analogue Scale, ranging from no pain (0mm) to extreme pain (100mm).
|
12 weeks
|
Investigator Global Rating of Pain Relief
Time Frame: 12 weeks
|
The Investigator Global Rating of Pain is a 3-item Likert-scale to answer the following question: "How do you rate this patient's overall pain relief with the drug?" with 3 possible answers: "very effective", "effective", or "ineffective".
|
12 weeks
|
Percentage Difference in WOMAC Pain Subscale Score From Baseline to Intervening Visits (Visits 2-4)
Time Frame: Week 0, week 3, week 6
|
Percentage of difference in WOMAC Pain Subscale score between baseline and intervening visits 2-4.
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.
|
Week 0, week 3, week 6
|
Percentage Difference in WOMAC Physical Function Subscale Score From Baseline to Intervening Visits (Visits 2-4)
Time Frame: Week 0, week 3, week 6
|
Percentage of difference in WOMAC Physical Function Subscale score between baseline and intervening visits 2-4.
The WOMAC scale is a 24-item questionnaire divided in 3 subscales.
The WOMAC Physical Function Subscale comprises 17 questions each rated on a 100mm visual analog scale (VAS) ranging from no pain (0mm) to extreme pain (100mm).
|
Week 0, week 3, week 6
|
Percentage of Participants Who Dropped Out From Trial by Dropout Reason
Time Frame: 12 weeks
|
Reasons for withdrawal from the trial were collected and the percentage of participants who dropped out from trial were calculated by dropout reason
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2003
Primary Completion (Actual)
August 1, 2003
Study Registration Dates
First Submitted
January 29, 2009
First Submitted That Met QC Criteria
January 29, 2009
First Posted (Estimate)
January 30, 2009
Study Record Updates
Last Update Posted (Estimate)
April 30, 2012
Last Update Submitted That Met QC Criteria
April 25, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MDT3-002
- NCT00832416 (Registry Identifier: ClinicalTrials.gov)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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