Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Hip - Full Text View

Sponsored by:	NicOx
Information provided by:	NicOx
ClinicalTrials.gov Identifier:	NCT00541489

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
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:

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Naproxen Naproxen sodium AZD 3582

U.S. FDA Resources

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
1: Placebo Comparator	Drug: Placebo bid
2: Active Comparator Naproxen 500 mg	Drug: Naproxen 500 mg, bid
3: Experimental 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:

Click here to learn more about this study - Efficacy and Safety Study of Naproxcinod in Subjects with Osteoarthritis of the Hip This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	HCT3012-X-303
Study First Received:	October 8, 2007
Last Updated:	February 19, 2009
ClinicalTrials.gov Identifier:	NCT00541489 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NicOx:

Osteoarthritis
Osteoarthritis, Hip

Study placed in the following topic categories:

Anti-Inflammatory Agents
Naproxen
Osteoarthritis
Joint Diseases
Cyclooxygenase Inhibitors
Cardiovascular Agents
Osteoarthritis, Hip
Rheumatic Diseases
Nitric Oxide Donors
Nitric Oxide

Signs and Symptoms
Musculoskeletal Diseases
Analgesics, Non-Narcotic
Arthritis
Naproxen-n-butyl nitrate
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Osteoarthritis
Physiological Effects of Drugs
Osteoarthritis, Hip
Gout Suppressants
Nitric Oxide Donors
Musculoskeletal Diseases
Sensory System Agents
Arthritis
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics

Naproxen
Joint Diseases
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Rheumatic Diseases
Cardiovascular Agents
Pharmacologic Actions
Analgesics, Non-Narcotic
Naproxen-n-butyl nitrate
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 28, 2009