A Study Comparing the Effectiveness and Safety of Varying Dose Strengths (100, 200, 300 and 400 mg) of Extended-release Tramadol HCl With Placebo for the Treatment of Osteoarthritis(OA) of the Knee and/or Hip

NCT00325858 | Completed Phase 3

• 1 other identifier: B02.CT3.023.TRA P03
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the effectiveness of multiple doses of once daily tramadol HCl ER (100, 200, 300 and 400 mg) to placebo in patients with moderate to severe pain due to OA. The study hypothesis is that tramadol HCl ER is safe and effective in the treatment of patients with moderate to severe pain due to OA.

Conditions

Chronic Pain

Keywords

osteoarthritis pain; knee; hip; extended-release analgesia; opioid

Outcome Measures

Primary Outcomes (1)

• The primary outcome is the change from baseline to Week 12 in the WOMAC OA Index pain and physical function subscale scores and the patient global assessment of disease activity.

Secondary Outcomes (1)

• The secondary outcomes include: the change from baseline in the daily arthritis pain intensity scores from patient diaries; WOMAC OA stiffness subscale score, OA pain intensity VAS for index and non-index joints, and Chronic Pain Sleep Inventory scale.

Interventions

Tramadol HCl ER DRUG

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with American College of Rheumatology (ACR) Functional Class I-III OA of the knee or hip
• Patients with involvement of at least one knee or hip joint that warrants treatment with COX-2 inhibitors, NSAIDS, acetaminophen, or opioid analgesics for at least 75 of the 90 days preceding the screening visit
• Patients with a pain intensity score in index joint \>=40 mm on the visual analog scale (VAS) at the baseline visit
• Patients who are able to discontinue acetaminophen, NSAIDS, COX-2 selective inhibitors, and other analgesics during the washout period and throughout the study
• Patients who are able to understand the study procedures and complete pain scales

You may not qualify if:

• Patients with a medical condition, other than OA, uncontrolled with treatment or any clinically significant condition that, in the investigator's opinion, precludes study participation or interferes with the assessment of chronic pain and other OA symptoms
• Patients with a diagnosis of inflammatory arthritis, gout, pseudo-gout or Paget's disease, that, in the investigator's opinion, interferes with the assessment of pain and other symptoms of OA
• Patients with a diagnosis of chronic pain syndrome
• Patients with an ACR or a clinical diagnosis of fibromyalgia
• Patients with a clinically significant form of joint disease or prior joint replacement surgery at the index joint
• Patients with an anticipated need for surgery or other invasive procedure in the index joint

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (1)

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Related Publications (1)

• Gana TJ, Pascual ML, Fleming RR, Schein JR, Janagap CC, Xiang J, Vorsanger GJ; 023 Study Group. Extended-release tramadol in the treatment of osteoarthritis: a multicenter, randomized, double-blind, placebo-controlled clinical trial. Curr Med Res Opin. 2006 Jul;22(7):1391-401. doi: 10.1185/030079906X115595.

  PMID: 16834838 BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2006
• First Posted: May 15, 2006
• Study Start: January 1, 2002
• Study Completion: December 1, 2003
• Last Updated: August 27, 2012

Record last verified: 2006-09

Locations

US (1)