Clinical Trials

Learn more about HZT-501

Clinical Trials

Horizon Therapeutics has closed enrollment
in both Phase 3 clinical studies

Horizon has successfully completed early supportive clinical studies on HZT-501 to:

  1. Validate the PK/PD formulation design
  2. Verify and define the effects and safety of several formulations on gastric pH
  3. Confirm that no significant drug-drug interactions exist between ibuprofen and famotidine
  4. Establish the comparative bioavailability of HZT-501 to approved reference drug products

Horizon has reached agreement with the FDA via a Special Protocol Assessment (SPA) for the Phase 3 trial program of HZT-501 which began in March 2007.

HZ-CA-301 and HZ-CA-303

Horizon Protocol HZ-CA-301 and HZ-CA-303 are Phase 3 trials that will evaluate the efficacy and safety of HZT-501 in reducing the risk of development of ibuprofen-associated upper gastrointestinal ulcers in patients who require use of ibuprofen. Both studies are of identical design and are being conducted in the United States. The studies are now closed for patient enrollment.

Duration of participation: up to 24 weeks of oral administration of study medication three times daily, followed by a 4- week safety follow-up period.

Who Can Participate?

SELECTED INCLUSION CRITERIA
In order to participate in this study, a person must have met the following:

  1. Male or female, aged 40-80 years inclusive.
  2. Did not use an NSAID (such as ibuprofen, naproxen) within the 30 days prior to study entry.
  3. Expected to require daily administration of an NSAID for at least the coming six months for conditions such as the following:
    • osteoarthritis
    • rheumatoid arthritis
    • chronic low back pain
    • chronic regional pain syndrome
    • chronic soft tissue pain

SELECTED EXCLUSION CRITERIA
Participation in the study is not allowed if a patient does not meet any the following:

  1. History of erosive esophagitis
  2. History of any of the following serious gastrointestinal complications: perforation of ulcers, gastric outlet obstruction due to ulcers, gastrointestinal bleeding.
  3. Current H. pylori infection.
  4. Use of an acid suppressant agent, misoprostol, or more than 325 mg/day of aspirin within the 14 days prior to study entry.
  5. Active cardiac, renal, and/or hepatic disease.
  6. Uncontrolled diabetes.
  7. Uncontrolled hypertension.
  8. Positive serum pregnancy test at Screening.
  9. Positive test at Screening for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
  10. Currently participating, or participation within the 30 days prior to study entry, in an investigational drug study

Please note there are other additional criteria.

Contact Information

For further information on the HZ-CA-301 and HZ-CA 303 studies study, please contact the Horizon Clinical Information line at 1-866-565-0259.

In the event of a medical emergency on either the HZ-CA-301 or HZ-CA 303 studies, please call 1-866-326-5053.

Disclosure of Risks

Please note that the safety and effectiveness of this product have not yet been established. As with ibuprofen and famotidine, this investigational product may not benefit you and may cause side effects that are not known or predictable at this time, but that may occur at the time of treatment or later. You should discuss these risks with your physician or a study doctor. All NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. The presence of famotidine in HZT-501 will not reduce this risk.

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