A Study Comparing the Effectiveness and Safety of Extended Release Tramadol Versus Placebo for the Treatment of Osteoarthritis (OA) of the Knee

NCT00348010 | Completed Phase 3

• 1 other identifier: B00.CT3.015.TRA PO3
• Study Type: interventional
• Target: 245
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare the analgesic effectiveness and safety of tramadol HCl ER to placebo in patients with moderate to severe pain due to osteoarthritis (OA). The study hypothesis is that tramadol HCl ER is effective and safe in the treatment of OA.

Conditions

Chronic Pain

Keywords

osteoarthritis; knee pain; extended release analgesia; opioid

Outcome Measures

Primary Outcomes (2)

• The primary efficacy outcome is the change in arthritis pain intensity score

• averages over the 12 weeks of the study.

Secondary Outcomes (4)

• The secondary outcomes include change from baseline in the daily arthritis

• pain intensity VAS score from patient diaries; WOMAC OA Index pain subscale

• scores for pain and physical function, patient's global assessment, patient's

• sleep assessment

Interventions

Tramadol HCl ER DRUG

Eligibility Criteria

• Age: 18 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; involvement of at least one knee joint that warrants treatment with NSAIDs, acetaminophen, or opioid analgesics for at least 75 of the 90 days preceding the screening visit; patients with radiographic evidence of osteoarthritis within the last 6 months; patients with a pain intensity in index joint \> = 40 mm on the visual analog scale (VAS) at the baseline visit; patients who are able to discontinue NSAIDs, COX-2 selective inhibitors, and other analgesics during the washout period and throughout double-blind study.

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

Related Publications (1)

• Babul N, Noveck R, Chipman H, Roth SH, Gana T, Albert K. Efficacy and safety of extended-release, once-daily tramadol in chronic pain: a randomized 12-week clinical trial in osteoarthritis of the knee. J Pain Symptom Manage. 2004 Jul;28(1):59-71. doi: 10.1016/j.jpainsymman.2003.11.006.

  PMID: 15223085 BACKGROUND

MeSH Terms

Conditions

Chronic Pain; Osteoarthritis

Condition Hierarchy (Ancestors)

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

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: July 2, 2006
• First Posted: July 4, 2006
• Study Start: November 1, 2000
• Study Completion: July 1, 2001
• Last Updated: June 21, 2012

Record last verified: 2012-06