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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Labopharm Inc.
ClinicalTrials.gov Identifier:
NCT00912015
First received: April 9, 2009
Last updated: April 25, 2012
Last verified: April 2012
  Purpose

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


Condition Intervention Phase
Pain
Osteoarthritis, Knee
Drug: Tramadol OAD
Drug: Tramadol OAD 100mg
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Labopharm Inc.:

Primary Outcome Measures:
  • Adverse Events: 12-months Safety Population [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 238
Study Start Date: March 2002
Study Completion Date: July 2003
Primary Completion Date: July 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tramadol OAD 200mg Drug: Tramadol OAD
Experimental: Tramadol OAD 300mg Drug: Tramadol OAD
Experimental: Tramadol OAD 400mg Drug: Tramadol OAD
Tramadol OAD 100mg
Despite provision in the protocol that the minimum daily dose was 200 mg, 2 patients took 100 mg against instructions.
Drug: Tramadol OAD 100mg

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. ESR < 40 mm/hour
  3. WOMAC Pain Subscales total score of more than or equal to 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 has signed and dated the REB approved, written, informed consent prior to study participation.

Exclusion Criteria:

  1. Known rheumatoid arthritis or any other rheumatoid disease.
  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 (BMI more than or equal to 35) (NIH, 2000)
  4. Major illness requiring hospitalization 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 have previously failed tramadol HCl therapy or those who discontinued tramadol HCl due to adverse events.
  7. 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.
  8. Patients who are taking or have taken another investigational agent within the last 30 days.
  9. Patients with a history of seizure disorder other than Infantile Febrile Seizures.
  10. Patients who are opioid dependent.
  11. Patients with bowel disease causing malabsorption.
  12. 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.
  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, would adversely affect the patient's ability to complete the study or its measures.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Labopharm Inc.
ClinicalTrials.gov Identifier: NCT00912015     History of Changes
Other Study ID Numbers: MDT3-001-E1-A1
Study First Received: April 9, 2009
Results First Received: April 9, 2009
Last Updated: April 25, 2012
Health Authority: Hungary: National Institute of Pharmacy
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Russia: Ministry of Health of the Russian Federation
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Analgesics
Tramadol
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014