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| Sponsored by: |
Horizon Therapeutics, Inc. |
|---|---|
| Information provided by: | Horizon Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT00450658 |
Purpose
The purpose of this study is to evaluate whether HZT-501 is effective in reducing the rate of development of ibuprofen-associated ulcers in patients who require long-term daily use of ibuprofen.
| Condition | Intervention | Phase |
|---|---|---|
|
Peptic Ulcer |
Drug: Ibuprofen/famotidine Drug: Ibuprofen |
Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Double-Blind, Phase 3 Study of the Efficacy and Safety of HZT-501 in Subjects Requiring NSAID Treatment |
| Estimated Enrollment: | 600 |
| Study Start Date: | March 2007 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
HZT-501: Ibuprofen 800mg/Famotidine 26.6mg
|
Drug: Ibuprofen/famotidine
HZT-501: Ibuprofen 800mg/famotidine 26.6mg orally 3 times daily for 24 weeks
|
|
2: Active Comparator
Ibuprofen 800mg
|
Drug: Ibuprofen
Ibuprofen 800mg orally 3 times daily for 24 weeks
|
HZT-501 is a combination product including ibuprofen and the acid reducing agent famotidine. The study is designed to determine whether the combination product reduces the rate of ulcer development in subjects who require long-term daily use of ibuprofen.
Subjects will be assigned randomly, in approximately a 2:1 ratio, to treatment with either HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg) or ibuprofen (800 mg) three times daily for a 24 week treatment period or until they develop either an endoscopically-diagnosed upper gastrointestinal ulcer and/or prohibitive toxicity. Subjects will visit the study center for Screening and at Weeks 4, 8, 16, and 24. Physical exams will be performed, and clinical laboratory measurements made, at selected times during the study. Endoscopic exams will be performed during Screening and at Weeks 8, 16, and 24. Subjects will be contacted four weeks following study completion.
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
History of any of the following serious gastrointestinal complications:
Please note that there are other additional criteria. The study center will determine if patients meet all of the criteria.
Contacts and Locations More Information
| Responsible Party: | Horizon Therapeutics, Inc. ( George Tidmarsh, MD, PhD ) |
| Study ID Numbers: | HZ-CA-301 |
| Study First Received: | March 19, 2007 |
| Last Updated: | October 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00450658 |
| Health Authority: | United States: Food and Drug Administration |
|
ibuprofen famotidine ulcers NSAIDS pain arthritis |
chronic regional pain syndrome chronic soft tissue pain osteoarthritis rheumatoid arthritis chronic low back pain |
|
Ibuprofen Osteoarthritis Gastrointestinal Diseases Ulcer Arthritis, Rheumatoid Low Back Pain Pain Intestinal Diseases Back Pain |
Histamine Digestive System Diseases Stomach Diseases Famotidine Arthritis Histamine phosphate Peptic Ulcer Duodenal Diseases |
|
Anti-Inflammatory Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cyclooxygenase Inhibitors Physiological Effects of Drugs Gastrointestinal Agents Histamine Agents Enzyme Inhibitors Pharmacologic Actions Histamine H2 Antagonists Pathologic Processes |
Histamine Antagonists Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Anti-Ulcer Agents Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Central Nervous System Agents |
