Double-Blind Follow-on Safety Study of HZT-501 (Ibuprofen 800 mg/Famotidine 26.6 mg) in Subjects Who Have Completed Participation in HZ-CA-301 (NCT00450658) or HZ-CA-303 (NCT00450216)

NCT00613106 | Completed Phase 3 Results DMC

• 1 other identifier: HZ-CA-304
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety of long-term treatment with HZT-501.

Conditions

Osteoarthritis; Rheumatoid Arthritis; Chronic Low Back Pain; Chronic Regional Pain Syndrome; Chronic Soft Tissue Pain

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment Emergent Adverse Events

  The objective of this study was to evaluate the long term safety of HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg). No efficacy analyses were planned or performed. Adverse event information was elicited from each participant by indirect questioning using a non-leading question, such as "Has anything bothered you since your last visit or is anything bothering you now?" Adverse event data may also have been volunteered by the participant to the investigator or designee. Physicians assessed the seriousness, severity and causality of each adverse event.

  28 weeks

Study Arms (2)

HZT-501

EXPERIMENTAL

HZT-501: ibuprofen 800mg/famotidine 26.6mg

Drug: HZT-501

Ibuprofen

ACTIVE COMPARATOR

Ibuprofen 800mg

Drug: Ibuprofen

Interventions

HZT-501 DRUG

Ibuprofen 800mg/famotidine 26.6 mg administered orally 3 times daily for 2 weeks

HZT-501

Ibuprofen DRUG

Ibuprofen 800mg administered orally 3 times daily for at least 28 weeks

Ibuprofen

Eligibility Criteria

• Age: 40 Years - 81 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Expected to continue to require daily administration of an NSAID for at least the coming 6 months.
• Subject completed the 24-week Treatment period of either Horizon Protocol HZ-CA-301 or HZ-CA-303

You may not qualify if:

• Subject developed or experienced any of the following while on either HZ-CA-301 or HZ-CA-303
• Malignant Disease of the gastrointestinal tract
• Erosive esophagitis
• Clinically significant cardiac, renal or hepatic disease
• Uncontrolled diabetes
• Positive pregnancy test on Study Day 0
• Please note that there are other additional criteria. The study center will determine if you meet all of the criteria.

Sponsors & Collaborators

• Amgen: lead

Study Sites (1)

PRA International

San Diego, California, 92122, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Arthritis, Rheumatoid; Complex Regional Pain Syndromes

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular 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: January 28, 2008
• First Posted: February 12, 2008
• Study Start: September 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: December 17, 2024
• Results First Posted: June 17, 2011

Record last verified: 2024-11

Locations

US (1)