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)
NCT ID: NCT00852917
Last Updated: 2012-04-30
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
552 participants
INTERVENTIONAL
2003-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1: Tramadol Once A Day 100mg
Tramadol Once A Day
One Tramadol Once A Day tablet at randomized dose daily.
2: Tramadol Once A Day 200mg
Tramadol Once A Day
One Tramadol Once A Day tablet at randomized dose daily.
3: Tramadol Once A Day 300mg
Tramadol Once A Day
One Tramadol Once A Day tablet at randomized dose daily.
4: Placebo
Placebo
One Placebo tablet daily.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tramadol Once A Day
One Tramadol Once A Day tablet at randomized dose daily.
Placebo
One Placebo tablet daily.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
2. CRP \< 8 ug/mL (if available at local lab) or ESR \< 40 mm/hr.
3. Total WOMAC (Western Ontario and McMaster University Osteoarthritis Index) Pain Subscale Score of \> 150 mm at Baseline corresponding with moderate to severe Osteoarthritis.
4. Oral and written language comprehension at a level sufficient to comply with the protocol and complete study-related materials.
5. 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
2. 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.
3. Evidence of effusion greater than 15 cc upon physical examination of the joint at Baseline (Visit 1).
4. BMI greater than or equal to 38.
5. Major illness, requiring hospitalization during the 3 months before commencement of the screening period.
6. 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.
7. Previous failure or discontinuation (due to adverse events) of tramadol HCl therapy.
8. 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.
9. Treatment with another investigational agent within the last 30 days.
10. A history of seizure disorder other than Infantile Febrile Seizures.
11. Previous or current opioid dependency.
12. Bowel disease causing malabsorption.
13. Pregnancy or lactating or childbearing potential and unwilling to utilize a medically approved method of contraception during participation in this clinical trial.
14. Significant liver disease, defined as active hepatitis or elevated liver enzymes \>3 times the upper boundary of the normal range.
15. Significant renal disease, defined as creatinine clearance \<30 mL/min as estimated by the method of Levey et al., 1999.
16. Current substance abuse or dependence, other than nicotine.
17. Allergy or adverse reaction to tramadol or any structurally similar drugs e.g. opiates.
18. 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.
40 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Labopharm Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
References
Explore related publications, articles, or registry entries linked to this study.
Fishman RL, Kistler CJ, Ellerbusch MT, Aparicio RT, Swami SS, Shirley ME, Jain AK, Fortier L, Robertson S, Bouchard S. Efficacy and safety of 12 weeks of osteoarthritic pain therapy with once-daily tramadol (Tramadol Contramid OAD). J Opioid Manag. 2007 Sep-Oct;3(5):273-80. doi: 10.5055/jom.2007.0015.
Related Links
Access external resources that provide additional context or updates about the study.
Approved labelling
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCT00852917
Identifier Type: REGISTRY
Identifier Source: secondary_id
MDT3-003
Identifier Type: -
Identifier Source: org_study_id