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

NCT00912015 | Completed Phase 3 Results

• 2 other identifiers: MDT3-001-E1-A1NCT00912015
• Study Type: interventional
• Target: 238
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Pain; Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• Adverse Events: 12-months Safety Population

  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

Study Arms (4)

Tramadol OAD 200mg

EXPERIMENTAL

Drug: Tramadol OAD

Tramadol OAD 300mg

EXPERIMENTAL

Drug: Tramadol OAD

Tramadol OAD 400mg

EXPERIMENTAL

Drug: Tramadol OAD

Tramadol OAD 100mg

OTHER

Despite provision in the protocol that the minimum daily dose was 200 mg, 2 patients took 100 mg against instructions.

Drug: Tramadol OAD 100mg

Interventions

Tramadol OAD DRUG

Tramadol OAD 200mg

Tramadol OAD 100mg DRUG

Tramadol OAD 100mg

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Labopharm Inc.: lead

MeSH Terms

Conditions

Pain; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Director of Regulatory Affairs
• Organization: Labopharm Inc.

1 450 686 1017

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2009
• First Posted: June 3, 2009
• Study Start: March 1, 2002
• Primary Completion: July 1, 2003
• Study Completion: July 1, 2003
• Last Updated: April 30, 2012
• Results First Posted: June 3, 2009

Record last verified: 2012-04