Efficacy and Safety Study of HZT-501 in Reducing the Risk of Ibuprofen-Associated Ulcers - Tabular View

Tracking Information
First Received Date ^ICMJE	March 19, 2007
Last Updated Date	October 23, 2008
Start Date ^ICMJE	March 2007
Primary Completion Date	September 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 29, 2008)	Proportion of subjects who develop endoscopically-diagnosed upper gastrointestinal ulcers. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: March 21, 2007)	Proportion of subjects who develop endoscopically-diagnosed upper gastrointestinal ulcers.
Change History	Complete list of historical versions of study NCT00450658 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 29, 2008)	The proportion of subjects who develop endoscopically-diagnosed gastric ulcers during the 24-week Treatment Period. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ] The proportion of subjects who develop endoscopically-diagnosed duodenal ulcers during the 24-week Treatment Period. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ] The incidence rate of NSAID-associated serious gastrointestinal complications. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: March 21, 2007)	The proportion of subjects who develop endoscopically-diagnosed gastric ulcers during the 24-week Treatment Period. The proportion of subjects who develop endoscopically-diagnosed duodenal ulcers during the 24-week Treatment Period. The incidence rate of NSAID-associated serious gastrointestinal complications.

Descriptive Information
Brief Title ^ICMJE	Efficacy and Safety Study of HZT-501 in Reducing the Risk of Ibuprofen-Associated Ulcers
Official Title ^ICMJE	A Randomized, Double-Blind, Phase 3 Study of the Efficacy and Safety of HZT-501 in Subjects Requiring NSAID Treatment
Brief Summary	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.
Detailed Description	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.
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Peptic Ulcer
Intervention ^ICMJE	Drug: Ibuprofen/famotidine Drug: Ibuprofen
Study Arms / Comparison Groups	Experimental: HZT-501: Ibuprofen 800mg/Famotidine 26.6mg Active Comparator: Ibuprofen 800mg
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	600
Completion Date	October 2008
Primary Completion Date	September 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Expected to require daily administration of a nonsteroidal anti-inflammatory drug (NSAID) for at least the coming six months for conditions such as osteoarthritis, rheumatoid arthritis, chronic low back pain, chronic regional pain syndrome, and chronic soft tissue pain. Did not use a NSAID within the 30 days prior to study entry Exclusion Criteria: History of erosive esophagitis History of any of the following serious gastrointestinal complications: perforation of ulcers, gastric outlet obstruction due to ulcers, gastrointestinal bleeding. Active cardiac, renal, and/or hepatic disease Current Helicobacter pylori (H. pylori) infection Use of an acid suppressant agent, misoprostol, or more than 325 mg/day of aspirin within the 14 days prior to study entry. Uncontrolled diabetes Uncontrolled hypertension Positive pregnancy test at screening Positive test at Screening for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C. Currently participating, or participation within 30 days prior to study entry, in an investigational drug study Please note that there are other additional criteria. The study center will determine if patients meet all of the criteria.
Gender	Both
Ages	40 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00450658
Responsible Party	George Tidmarsh, MD, PhD, Horizon Therapeutics, Inc.
Study ID Numbers ^ICMJE	HZ-CA-301
Study Sponsor ^ICMJE	Horizon Therapeutics, Inc.
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Horizon Therapeutics, Inc.
Verification Date	October 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP