A Comparison of the Analgesic Efficacy and Safety of Once Daily Tramadol HCl / Contramid® Tablets to Twice Daily Tramadol HCl (SR) for the Treatment of Osteoarthritis of the Knee
NCT ID: NCT00950651
Last Updated: 2012-04-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
431 participants
INTERVENTIONAL
2002-03-31
2002-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1 Tramadol HCl Contramid® Once A Day
Tramadol HCl Contramid® Once A Day
The patients orally self-administered the study medication: either 100, 200, 300 or 400 mg Tramadol HCl Contramid® Once A Day. Each patient was titrated to his or her optimum dose (up to a maximum of 400 mg) during the Titration Phase, which lasted between 4 and 12 days. The optimum dose was taken throughout the study.
2 Tramadol HCl Twice a day (SR)
Tramadol HCl Twice a day
The patients orally self-administered the study medication: either 200, 300 or 400 mg Tramadol HCl Twice a day. Each patient was titrated to his or her optimum dose (up to a maximum of 400 mg) during the Titration Phase, which lasted between 4 and 12 days. The optimum dose was taken throughout the study.
Interventions
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Tramadol HCl Contramid® Once A Day
The patients orally self-administered the study medication: either 100, 200, 300 or 400 mg Tramadol HCl Contramid® Once A Day. Each patient was titrated to his or her optimum dose (up to a maximum of 400 mg) during the Titration Phase, which lasted between 4 and 12 days. The optimum dose was taken throughout the study.
Tramadol HCl Twice a day
The patients orally self-administered the study medication: either 200, 300 or 400 mg Tramadol HCl Twice a day. Each patient was titrated to his or her optimum dose (up to a maximum of 400 mg) during the Titration Phase, which lasted between 4 and 12 days. The optimum dose was taken throughout the study.
Eligibility Criteria
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Inclusion Criteria
* Knee pain at study enrolment,
* 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 1 year prior to entry into the study.
2. ESR \< 40 mm/h
3. Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Pain Subscales total score equal to or more than 150 mm at baseline.
4. Oral and written language comprehension at a level sufficient to comply with the protocol and complete study-related materials.
5. The Patient signed and dated the (IEC) approved, written, informed consent 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; heritable arthritic disorders; or collagen gene mutations.
3. Obesity Class II \[body mass index (BMI) equal to or more than 35 kg/m2\] (NIH, 2000)
4. Major illness that required hospitalisation during the 3 months before commencement of the screening period.
5. Unwillingness to cease taking medication other than the study medication for arthritic pain, any other concomitant pain, or OA medications.
6. Patients who had previously failed tramadol HCl therapy or those who discontinued tramadol HCl due to AEs.
7. Patients who within the 3 weeks prior to study entry took the following medications: monoamine oxidase inhibitors; tricyclic antidepressants and other tricyclic compounds (e.g. cyclobenzaprine, promethazine); neuroleptics; selective serotonin reuptake inhibitors; or other drugs which reduce seizure threshold.
8. Patients who took another investigational agent within the 30 days prior to study entry.
9. Patients with a history of seizure disorder other than Infantile Febrile Seizures.
10. Patients who were opioid dependent.
11. Patients with bowel disease causing malabsorption.
12. Patients who were pregnant or lactating or patients of child-bearing potential who were unwilling to utilise a medically approved method of contraception during participation in this clinical trial.
13. Patients with significant liver disease, defined as active hepatitis or elevated liver enzymes \>3 times the upper boundary of the normal range.
14. Patients with significant renal disease, defined as creatinine clearance \<30 mL/min as estimated by the method of Levey et al., 1999.
15. Current substance abuse or dependence, other than nicotine.
16. Allergy or adverse reaction to tramadol or any structurally similar drugs e.g. opiates.
17. Any other condition that, in the opinion of the investigators, adversely affected the patient's ability to complete the study or its measures.
40 Years
75 Years
ALL
No
Sponsors
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Labopharm Inc.
INDUSTRY
Responsible Party
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References
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Mongin G, Yakusevich V, Kope A, Shostak N, Pikhlak E, Popdan L, Simon J, Navarro C, Fortier L, Robertson S, Bouchard S. Efficacy and Safety Assessment of a Novel Once-Daily Tablet Formulation of Tramadol : A Randomised, Controlled Study versus Twice-Daily Tramadol in Patients with Osteoarthritis of the Knee. Clin Drug Investig. 2004;24(9):545-58. doi: 10.2165/00044011-200424090-00005.
Other Identifiers
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NCT00950651
Identifier Type: REGISTRY
Identifier Source: secondary_id
MDT3-001-E1
Identifier Type: -
Identifier Source: org_study_id