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

Primary Purpose

Peptic Ulcer

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
HZT-501
Ibuprofen
Sponsored by
Horizon Pharma Ireland, Ltd., Dublin Ireland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Peptic Ulcer focused on measuring ibuprofen, famotidine, ulcers, NSAIDS, pain, arthritis, chronic regional pain syndrome, chronic soft tissue pain, osteoarthritis, rheumatoid arthritis, chronic low back pain

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    1

    2

    Arm Description

    HZT-501: Ibuprofen 800mg/Famotidine 26.6mg

    Ibuprofen 800mg

    Outcomes

    Primary Outcome Measures

    Number of Subjects Who Develop Endoscopically-diagnosed Upper Gastrointestinal Ulcers Confirmed by Endoscopy.
    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

    Number of Subjects Who Develop Endoscopically-diagnosed Gastric Ulcers During the 24-week Treatment Period.
    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.
    Number of Subjects Who Develop Endoscopically-diagnosed Duodenal Ulcers During the 24-week Treatment Period.
    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.
    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.

    Full Information

    First Posted
    March 19, 2007
    Last Updated
    April 22, 2013
    Sponsor
    Horizon Pharma Ireland, Ltd., Dublin Ireland
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00450658
    Brief Title
    Efficacy and Safety Study of HZT-501 in Reducing the Risk of Ibuprofen-associated Ulcers
    Official Title
    A Randomized, Double-Blind, Phase 3 Study of the Efficacy and Safety of HZT-501 in Subjects Requiring NSAID Treatment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2007 (undefined)
    Primary Completion Date
    September 2008 (Actual)
    Study Completion Date
    October 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Horizon Pharma Ireland, Ltd., Dublin Ireland

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Peptic Ulcer
    Keywords
    ibuprofen, famotidine, ulcers, NSAIDS, pain, arthritis, chronic regional pain syndrome, chronic soft tissue pain, osteoarthritis, rheumatoid arthritis, chronic low back pain

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    627 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    HZT-501: Ibuprofen 800mg/Famotidine 26.6mg
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    Ibuprofen 800mg
    Intervention Type
    Drug
    Intervention Name(s)
    HZT-501
    Intervention Description
    HZT-501: Ibuprofen 800mg/famotidine 26.6mg orally 3 times daily for 24 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Ibuprofen
    Intervention Description
    Ibuprofen 800mg orally 3 times daily for 24 weeks
    Primary Outcome Measure Information:
    Title
    Number of Subjects Who Develop Endoscopically-diagnosed Upper Gastrointestinal Ulcers Confirmed by Endoscopy.
    Description
    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.
    Time Frame
    24 weeks
    Secondary Outcome Measure Information:
    Title
    Number of Subjects Who Develop Endoscopically-diagnosed Gastric Ulcers During the 24-week Treatment Period.
    Description
    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.
    Time Frame
    24 weeks
    Title
    Number of Subjects Who Develop Endoscopically-diagnosed Duodenal Ulcers During the 24-week Treatment Period.
    Description
    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.
    Time Frame
    24 weeks
    Title
    The Incidence Rate of NSAID-associated Serious Gastrointestinal Complications.
    Description
    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.
    Time Frame
    24 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26165391
    Citation
    Bello AE, Kent JD, Holt RJ. Gastroprotective efficacy and safety of single-tablet ibuprofen/famotidine vs ibuprofen in older persons. Phys Sportsmed. 2015 Jul;43(3):193-9. doi: 10.1080/00913847.2015.1066229. Epub 2015 Jul 13.
    Results Reference
    derived

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

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