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

NCT00450658 | Completed Phase 3 Results DMC

• 1 other identifier: HZ-CA-301
• Study Type: interventional
• Target: 627
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Peptic Ulcer

Keywords

ibuprofen; famotidine; ulcers; NSAIDS; pain; arthritis; chronic regional pain syndrome; chronic soft tissue pain; osteoarthritis; rheumatoid arthritis; chronic low back pain

Outcome Measures

Primary Outcomes (1)

• 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.

  24 weeks

Secondary Outcomes (3)

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

  24 weeks

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

  24 weeks

• The Incidence Rate of NSAID-associated Serious Gastrointestinal Complications.

  24 weeks

Study Arms (2)

1

EXPERIMENTAL

HZT-501: Ibuprofen 800mg/Famotidine 26.6mg

Drug: HZT-501

2

ACTIVE COMPARATOR

Ibuprofen 800mg

Drug: Ibuprofen

Interventions

HZT-501 DRUG

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

1

Ibuprofen DRUG

Ibuprofen 800mg orally 3 times daily for 24 weeks

2

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead

Related Publications (1)

• 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.

  PMID: 26165391 DERIVED

MeSH Terms

Conditions

Peptic Ulcer; Ulcer; Pain; Arthritis; Complex Regional Pain Syndromes; Osteoarthritis; Arthritis, Rheumatoid

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Joint Diseases; Musculoskeletal Diseases; Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Amy Grahn, MS Senior Vice President, Clinical Development and Operations
• Organization: Horizon Pharma, Inc.

agrahn@horizonpharma.com

224-383-3012

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2007
• First Posted: March 22, 2007
• Study Start: March 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: October 1, 2008
• Last Updated: December 16, 2024
• Results First Posted: June 21, 2011

Record last verified: 2024-11