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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) (HZ-CA-304)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Horizon Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT00613106
First received: January 28, 2008
Last updated: April 23, 2013
Last verified: April 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Osteoarthritis
Rheumatoid Arthritis
Chronic Low Back Pain
Chronic Regional Pain Syndrome
Chronic Soft Tissue Pain
 Drug: HZT-501
Drug: Ibuprofen
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Double-Blind Follow-On Safety Study of HZT-501 (Ibuprofen 800 mg/Famotidine 26.6 mg)in Subjects Who Have Completed Participation in Horizon Protocol HZ-CA-301 (NCT00450658)or Horizon Protocol HZ-CA-303 (NCT00450216)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Horizon Pharma, Inc.:

Primary Outcome Measures:
  • Number of Participants With Treatment Emergent Adverse Events [ Time Frame: 28 weeks ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 179
Study Start Date: September 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HZT-501
HZT-501: ibuprofen 800mg/famotidine 26.6mg
 Drug: HZT-501
Ibuprofen 800mg/famotidine 26.6 mg administered orally 3 times daily for 2 weeks
Active Comparator: Ibuprofen
Ibuprofen 800mg
 Drug: Ibuprofen
Ibuprofen 800mg administered orally 3 times daily for at least 28 weeks

Detailed Description:

Subject who have completed the 24-week Treatment Period of Horizon Protocol HZ-CA-301 or HZ-CA-303 without developing an upper gastrointestinal ulcer and who are expected to continue to require daily administration of an NSAID for the next 6 months will receive treatment with the same study medication received while participating in HZ-CA-301 or HZ-CA-303.

  Eligibility

Ages Eligible for Study:   40 Years to 81 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Subject didn't meet all of the Inclusion and Exclusion Criteria for Horizon Protocol HZ-CA-301 or HZ-CA-303
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00613106

Locations
United States, California
PRA International
San Diego, California, United States, 92122
Sponsors and Collaborators
Horizon Pharma, Inc.
  More Information

No publications provided

Responsible Party: Horizon Pharma, Inc.
ClinicalTrials.gov Identifier: NCT00613106     History of Changes
Other Study ID Numbers: HZ-CA-304
Study First Received: January 28, 2008
Results First Received: May 23, 2011
Last Updated: April 23, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Back Pain
Low Back Pain
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
 Famotidine
Ibuprofen
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics

ClinicalTrials.gov processed this record on May 19, 2013