Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Hip

This study has been completed.
Sponsor:
Information provided by:
NicOx
ClinicalTrials.gov Identifier:
NCT00541489
First received: October 8, 2007
Last updated: February 19, 2009
Last verified: February 2009
  Purpose

To study the efficacy and safety of Naproxcinod vs. Placebo and Naproxen in the treatment of signs and symptoms of Osteoarthritis.


Condition Intervention Phase
Osteoarthritis
Osteoarthritis, Hip
Drug: Naproxcinod
Drug: Naproxen
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 13-Week, Phase 3, Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo Bid and Naproxen 500 mg Bid, Controlled Study on the Efficacy on Signs and Symptoms, and Safety of Naproxcinod (HCT3012) 750 mg Bid, in Patients With Osteoarthritis of the Hip

Resource links provided by NLM:


Further study details as provided by NicOx:

Primary Outcome Measures:
  • The primary objective of this study is to show that Naproxcinod is superior to placebo in relieving OA signs and symptoms in subjects with OA of the hip

Estimated Enrollment: 800
Study Start Date: June 2007
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: Placebo
bid
Active Comparator: 2
Naproxen 500 mg
Drug: Naproxen
500 mg, bid
Experimental: 3
Naproxcinod 750 mg
Drug: Naproxcinod
750 mg, bid

Detailed Description:

This is a 13 week randomized, double-blind, parallel group, multicenter study comparing efficacy and safety of Naproxcinod, Placebo and Naproxen.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women (40 or older) with a diagnosis of primary OA of the hip
  • Must be a current chronic user of NSAIDS or acetaminophen
  • Must discontinue all analgesic therapy at Screening

Exclusion Criteria:

  • Uncontrolled Hypertension or Diabetes
  • Hepatic or renal impairment
  • Current or expected use of anticoagulant
  • Clinically relevant abnormal ECG
  • A history of alcohol or drug abuse
  • Diagnosis of gastric or duodenal ulceration and/or history of significant gastro‑duodenal bleeding, within the last 6 months
  • Current medical disease, including arthritic, that could confound or interfere with the evaluation of efficacy
  • Candidates for imminent joint replacement
  • Participation within 30 days prior to screening in another investigational study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00541489

  Show 48 Study Locations
Sponsors and Collaborators
NicOx
  More Information

Additional Information:
No publications provided by NicOx

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00541489     History of Changes
Other Study ID Numbers: HCT3012-X-303
Study First Received: October 8, 2007
Last Updated: February 19, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by NicOx:
Osteoarthritis
Osteoarthritis, Hip

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Naproxen
Naproxen-n-butyl nitrate
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Nitric Oxide Donors
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 21, 2014