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

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ClinicalTrials.gov Identifier: NCT00450658
Recruitment Status : Completed
First Posted : March 22, 2007
Results First Posted : June 21, 2011
Last Update Posted : April 29, 2013
Sponsor:
Information provided by (Responsible Party):
Horizon Pharma Ireland, Ltd., Dublin Ireland

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.

Condition or disease Intervention/treatment Phase
Peptic Ulcer Drug: HZT-501 Drug: Ibuprofen Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 627 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : March 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Peptic Ulcer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
HZT-501: Ibuprofen 800mg/Famotidine 26.6mg
Drug: HZT-501
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



Primary Outcome Measures :
  1. Number of Subjects Who Develop Endoscopically-diagnosed Upper Gastrointestinal Ulcers Confirmed by Endoscopy. [ Time Frame: 24 weeks ]
    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 :
  1. Number of Subjects Who Develop Endoscopically-diagnosed Gastric Ulcers During the 24-week Treatment Period. [ Time Frame: 24 weeks ]
    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.

  2. Number of Subjects Who Develop Endoscopically-diagnosed Duodenal Ulcers During the 24-week Treatment Period. [ Time Frame: 24 weeks ]
    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.

  3. The Incidence Rate of NSAID-associated Serious Gastrointestinal Complications. [ Time Frame: 24 weeks ]
    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.



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Horizon Pharma Ireland, Ltd., Dublin Ireland
ClinicalTrials.gov Identifier: NCT00450658     History of Changes
Other Study ID Numbers: HZ-CA-301
First Posted: March 22, 2007    Key Record Dates
Results First Posted: June 21, 2011
Last Update Posted: April 29, 2013
Last Verified: April 2013

Keywords provided by Horizon Pharma Ireland, Ltd., Dublin Ireland:
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:
Ulcer
Peptic Ulcer
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Ibuprofen
Famotidine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Ulcer Agents
Gastrointestinal Agents
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents