Double-Blind Follow-on Safety Study of HZT-501 in Subjects Who Have Completed Participation in HZ-CA-301 or HZ-CA-303 - Full Text View

Sponsor:	Horizon Therapeutics, Inc.
Information provided by:	Horizon Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT00613106

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 III

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 in Subjects Who Have Completed Participation in Horizon Protocol HZ-CA-301 or Horizon Protocol HZ-CA-303

Resource links provided by NLM:

MedlinePlus related topics: Back Pain Osteoarthritis Rheumatoid Arthritis

Drug Information available for: Ibuprofen

U.S. FDA Resources

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

Primary Outcome Measures:

Incidence of 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. No efficacy analyses were planned or performed.

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 Therapeutics, Inc.

More Information

No publications provided

Responsible Party:	George Tidmarsh, MD, PhD, Horizon Therapeutics, 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:	May 23, 2011
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

Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012