- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00912015
A Comparison of the Analgesic Efficacy and Safety of Once Daily Tramadol OAD Tablets to Twice Daily Tramadol BID for the Treatment of Osteoarthritis of the Knee (Extension Protocol) and Open Label Safety Follow-Up
April 25, 2012 updated by: Labopharm Inc.
The purpose of this study is to evaluate the long-term safety (up to one year) of Tramadol Once-A-Day (OAD) tablets at the highest doses: 200-400 mg
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
238
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
38 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Male or Female patients between the ages of 40-75 with a diagnosis of Osteoarthritis of the knee consistent with the ACR Clinical Classification Criteria for Arthritis of the Knee (Altman, R. et al., 1991):
- 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 one year prior to entry into the study.
- ESR < 40 mm/hour
- WOMAC Pain Subscales total score of more than or equal to 150 mm at baseline.
- Oral and written language comprehension at a level sufficient to comply with the protocol and complete study-related materials.
- The Patient has signed and dated the REB approved, written, informed consent 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; heritable arthritic disorders; or collagen gene mutations.
- Obesity Class II (BMI more than or equal to 35) (NIH, 2000)
- Major illness requiring hospitalization during the 3 months before commencement of the screening period.
- Unwillingness to cease taking medication other than the study medication for arthritic pain, any other concomitant pain, or OA medications.
- Patients who have previously failed tramadol HCl therapy or those who discontinued tramadol HCl due to adverse events.
- Patients who are taking or within the last 3 weeks have taken 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.
- Patients who are taking or have taken another investigational agent within the last 30 days.
- Patients with a history of seizure disorder other than Infantile Febrile Seizures.
- Patients who are opioid dependent.
- Patients with bowel disease causing malabsorption.
- Patients who are pregnant or lactating or patients of child-bearing potential who are unwilling to utilize a medically approved method of contraception during participation in this clinical trial.
- Patients with significant liver disease, defined as active hepatitis or elevated liver enzymes >3 times the upper boundary of the normal range.
- Patients with 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 adversely affect 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: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tramadol OAD 200mg
|
|
Experimental: Tramadol OAD 300mg
|
|
Experimental: Tramadol OAD 400mg
|
|
Other: Tramadol OAD 100mg
Despite provision in the protocol that the minimum daily dose was 200 mg, 2 patients took 100 mg against instructions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Events: 12-months Safety Population
Time Frame: 12 months
|
Spontaneous adverse events were recorded for patients who received the same dose for at least 350 days.
A treatment emergent adverse event (TEAE) was associated to the dose level on which a patient was 2 days prior to the TEAE.
Only TEAEs which could be associated with the dose level on which the patient was for the longest time were considered.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
March 1, 2002
Primary Completion (Actual)
July 1, 2003
Study Completion (Actual)
July 1, 2003
Study Registration Dates
First Submitted
April 9, 2009
First Submitted That Met QC Criteria
June 2, 2009
First Posted (Estimate)
June 3, 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
- MDT3-001-E1-A1
- NCT00912015 (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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