Efficacy and Safety Study of HZT-501 in Reducing the Risk of Ibuprofen-associated Ulcers - Full Text View

Sponsor:	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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	A Randomized, Double-Blind, Phase 3 Study of the Efficacy and Safety of HZT-501 in Subjects Requiring NSAID Treatment

Resource links provided by NLM:

MedlinePlus related topics: Peptic Ulcer

Drug Information available for: Ibuprofen Famotidine

U.S. FDA Resources

Further study details as provided by Horizon Therapeutics, Inc.:

Primary Outcome Measures:

Proportion of Subjects Who Develop Endoscopically-diagnosed Upper Gastrointestinal Ulcers Confirmed by Endoscopy. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
The primary efficacy endpoint was the number of subjects with upper gastrointestinal (i.e., gastric and/or duodenal) ulcer at any time throughout 24 weeks of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter with unequivocal depth. A subject is considered to have completed the study if all scheduled assessments up through the Week 24 visit have been performed.

Secondary Outcome Measures:

The Proportion of Subjects Who Develop Endoscopically-diagnosed Gastric Ulcers During the 24-week Treatment Period. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
The secondary efficacy endpoint was the number of subjects with gastric ulcer at any time throughout 24 weeks of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter with unequivocal depth. A subject is considered to have completed the study if all scheduled assessments up through the Week 24 visit have been performed.
The Proportion of Subjects Who Develop Endoscopically-diagnosed Duodenal Ulcers During the 24-week Treatment Period. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
The secondary efficacy endpoint was the number of subjects with duodenal ulcer at any time throughout the 24 weeks of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter with unequivocal depth. A subject is considered to have completed the study if all scheduled assessments up through the Week 24 visit have been performed.
The Incidence Rate of NSAID-associated Serious Gastrointestinal Complications. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
The secondary efficacy endpoint was the number of subjects developing a NSAID-associated serious GI complication at any time throughout 6 months of treatment. A NSAID-associated serious GI complication was defined as a perforation of ulcers, gastric outlet obstruction due to ulcers, and/or GI bleeding.

Enrollment:	627
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
Experimental: 1 HZT-501: Ibuprofen 800mg/Famotidine 26.6mg	Drug: Ibuprofen/famotidine HZT-501: Ibuprofen 800mg/famotidine 26.6mg orally 3 times daily for 24 weeks
Active Comparator: 2 Ibuprofen 800mg	Drug: Ibuprofen Ibuprofen 800mg orally 3 times daily for 24 weeks

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.

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

Additional Information:

subject recruitment website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	George Tidmarsh, MD, PhD, Horizon Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT00450658 History of Changes
Other Study ID Numbers:	HZ-CA-301
Study First Received:	March 19, 2007
Results First Received:	May 17, 2011
Last Updated:	May 17, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Horizon Therapeutics, Inc.:

ibuprofen
famotidine
ulcers
NSAIDS
pain
arthritis

chronic regional pain syndrome
chronic soft tissue pain
osteoarthritis
rheumatoid arthritis
chronic low back pain

Additional relevant MeSH terms:

Peptic Ulcer
Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Pathologic Processes
Famotidine
Ibuprofen
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H2 Antagonists

Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012