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

Condition(s) targeted: Peptic Ulcer

Intervention: Ibuprofen/famotidine (Drug); Ibuprofen (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Horizon Therapeutics, Inc.

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.

Official title: A Randomized, Double-Blind, Phase 3 Study of the Efficacy and Safety of HZT-501 in Subjects Requiring NSAID Treatment

Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Proportion of subjects who develop endoscopically-diagnosed upper gastrointestinal ulcers.

Secondary outcome:

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.

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.

Minimum age: 40 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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.

Medici Group Central Contact, King of Prussia, Pennsylvania 19406, United States

subject recruitment website

Starting date: March 2007
Ending date: November 2008
Last updated: March 17, 2008