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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)

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ClinicalTrials.gov Identifier: NCT00613106
Recruitment Status : Completed
First Posted : February 12, 2008
Results First Posted : June 17, 2011
Last Update Posted : April 30, 2013
Sponsor:
Information provided by (Responsible Party):
Horizon Pharma Ireland, Ltd., Dublin Ireland

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

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

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 179 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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)
Study Start Date : September 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   40 Years to 81 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00613106


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

Responsible Party: Horizon Pharma Ireland, Ltd., Dublin Ireland
ClinicalTrials.gov Identifier: NCT00613106     History of Changes
Other Study ID Numbers: HZ-CA-304
First Posted: February 12, 2008    Key Record Dates
Results First Posted: June 17, 2011
Last Update Posted: April 30, 2013
Last Verified: April 2013

Additional relevant MeSH terms:
Osteoarthritis
Arthritis, Rheumatoid
Back Pain
Low Back Pain
Nociceptive Pain
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Ibuprofen
Famotidine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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