Efficacy and Safety Study of HZT-501 in Subjects Requiring Nonsteroidal Anti-Inflammatory Drug (NSAID) Treatment

NCT00450216 | Completed Phase 3 Results DMC

• 1 other identifier: HZ-CA-303
• Study Type: interventional
• Target: 906
• 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

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 Participants Who Develop Endoscopically-diagnosed Gastric Ulcers

  The primary efficacy endpoint was the number of participants 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 participant 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 Participants Who Develop Endoscopically-diagnosed Upper Gastrointestinal (UGI) Ulcers During the 24-week Treatment Period.

  24 weeks

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

  24 weeks

• The Number of Participants Developing Non-steroidal Anti-inflammatory (NSAID)Associated Serious Gastrointestinal Complications (Perforation of Ulcers, Gastric Outlet Obstruction Due to Ulcers, Gastrointestinal Bleeding)

  24 weeks

Study Arms (2)

1

EXPERIMENTAL

HZT-501: Ibuprofen 800mg/famotidine 26.6mg

Drug: Ibuprofen/famotidine

2

ACTIVE COMPARATOR

Ibuprofen 800mg

Drug: Ibuprofen

Interventions

Ibuprofen/famotidine DRUG

HZT-501: Ibuprofen800mg/famotidine 26.6mg administered orally 3 times daily for 24 weeks

1

Ibuprofen DRUG

Ibuprofen 800mg administered 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 an 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, or
• 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

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

Interventions

Ibuprofen; Famotidine

Condition Hierarchy (Ancestors)

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; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

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: August 1, 2008
• Study Completion: October 1, 2008
• Last Updated: December 16, 2024
• Results First Posted: June 21, 2011

Record last verified: 2024-11