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

NCT00950651 | Completed Phase 3 Results

• 2 other identifiers: MDT3-001-E1NCT00950651
• Study Type: interventional
• Target: 431
• Locations: 0 countries
• Sites: N/A

Brief Summary

A randomised, multi-centre, double-blind, double dummy, two arm parallel design study to compare the efficacy, safety, and clinical benefit of the test and reference product after treatment for 84 days in patients with osteoarthritis of the knee.

Conditions

Osteoarthritis, Knee; Pain

Outcome Measures

Primary Outcomes (1)

• Percentage of Change From Baseline in WOMAC Pain Subscale Score at Week 12

  The WOMAC is a statistically validated, 24-item questionnaire assessing current OA symptoms and functional limitations. The Pain subscale score consists of 5 items each rated on a 100mm VAS scale (0mm=no pain to 100mm=extreme pain). In case of premature discontinuation, the last assessment was used to calculate the percentage of change.

  Baseline to week 12

Secondary Outcomes (20)

• Arthritis Pain at the End of Dosing Interval (24-hour Efficacy)

  12 weeks

• Percentage of Change From Baseline in WOMAC Stiffness Subscale Score at Week 12

  Baseline to week 12

• Percentage of Change From Baseline in WOMAC Physical Function Subscale Score at Week 12

  Baseline to week 12

• Percentage of Change From Baseline in WOMAC Total Score at Week 12

  Baseline to week 12

• Percentage of Change From Baseline in Current Pain at Week 12

  Baseline to week 12

Study Arms (2)

1 Tramadol HCl Contramid® Once A Day

EXPERIMENTAL

Drug: Tramadol HCl Contramid® Once A Day

2 Tramadol HCl Twice a day (SR)

ACTIVE COMPARATOR

Drug: Tramadol HCl Twice a day

Interventions

Tramadol HCl Contramid® Once A Day DRUG

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.

1 Tramadol HCl Contramid® Once A Day

Tramadol HCl Twice a day DRUG

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.

2 Tramadol HCl Twice a day (SR)

Eligibility Criteria

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

You may qualify if:

• Males or Females between the ages of 40 and 75 with a diagnosis of Osteoarthritis (OA) of the knee consistent with the American College of Rheumatology (ACR) Clinical Classification Criteria for Arthritis of the Knee (Altman, R. et al., 1986):
• 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.
• ESR \< 40 mm/h
• Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Pain Subscales total score equal to or more than 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 signed and dated the (IEC) 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 \[body mass index (BMI) equal to or more than 35 kg/m2\] (NIH, 2000)
• Major illness that required hospitalisation 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 had previously failed tramadol HCl therapy or those who discontinued tramadol HCl due to AEs.
• 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.
• Patients who took another investigational agent within the 30 days prior to study entry.
• Patients with a history of seizure disorder other than Infantile Febrile Seizures.
• Patients who were opioid dependent.
• Patients with bowel disease causing malabsorption.
• 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.
• 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

Related Publications (1)

• 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.

  PMID: 17523716 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain

Condition Hierarchy (Ancestors)

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

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: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2009
• First Posted: August 3, 2009
• Study Start: March 1, 2002
• Primary Completion: November 1, 2002
• Study Completion: November 1, 2002
• Last Updated: April 30, 2012
• Results First Posted: August 3, 2009

Record last verified: 2012-04