A Study Comparing the Effectiveness and Safety of Extended Release Tramadol HCl at 100 mg, 200 mg and 300 mg Doses to Placebo for the Treatment of Moderate to Severe Pain Due to Osteoarthritis (OA)

NCT00348452 | Completed Phase 3

• 1 other identifier: B02.CT3.021.TRA P03
• Study Type: interventional
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare the analgesic efficacy and safety of tramadol HCl ER 100 mg, 200 mg and 300 mg once a day (QD), with placebo in patients with moderate to severe pain due to OA. For the purposes of this study, celecoxib will serve as a positive control to validate the sensitivity of the model. The study hypothesis is that tramadol HCl ER is safe and effective in the treatment of 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: change from baseline in the daily arthritis pain intensity scores from patient diaries, WOMAC OA stiffness subscale scores, OA pain intensity VAS for index and non-index joints, and Chronic Pain Sleep Inventory scale

Interventions

tramadol HCl ER; celecoxib DRUG

Eligibility Criteria

• Age: 18 Years - 80 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 knee or hip joint that warrants treatment with COX-2 selective 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 all analgesics other than the study medication throughout the study;
• Patients who are able to understand the study procedures and complete the 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 diagnoses 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 any other 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

MeSH Terms

Conditions

Chronic Pain

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

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 3, 2006
• First Posted: July 4, 2006
• Study Start: September 1, 2002
• Study Completion: August 1, 2003
• Last Updated: June 21, 2012

Record last verified: 2012-06