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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.
Information provided by (Responsible Party):
Horizon Pharma Ireland, Ltd., Dublin Ireland Identifier:
First received: January 28, 2008
Last updated: April 23, 2013
Last verified: April 2013
The purpose of this study is to evaluate the safety of long-term treatment with HZT-501.

Condition Intervention Phase
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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:

Further study details as provided by Horizon Pharma Ireland, Ltd., Dublin Ireland:

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

Ages Eligible for Study:   40 Years to 81 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00613106

United States, California
PRA International
San Diego, California, United States, 92122
Sponsors and Collaborators
Horizon Pharma Ireland, Ltd., Dublin Ireland
  More Information

Responsible Party: Horizon Pharma Ireland, Ltd., Dublin Ireland 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

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Back Pain
Low Back Pain
Nociceptive Pain
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Ulcer Agents processed this record on May 25, 2017