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Completed

NCT Number: NCT00450658

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

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.

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Key information

Conditions

Peptic Ulcer Arthritis Arthritis, Rheumatoid Autoimmune Diseases Autonomic Nervous System Diseases Complex Regional Pain Syndromes Connective Tissue Diseases Digestive System Diseases Duodenal Diseases Gastrointestinal Diseases Immune System Diseases Intestinal Diseases Joint Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Osteoarthritis Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Rheumatic Diseases Signs and Symptoms Skin and Connective Tissue Diseases Stomach Diseases Ulcer

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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 with completed results acquired from Horizon in 2024

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HZT-501

Drug

HZT-501: Ibuprofen 800mg/famotidine 26.6mg orally 3 times daily for 24 weeks

Ibuprofen

Drug

Ibuprofen 800mg orally 3 times daily for 24 weeks

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 22, 2007
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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