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| Sponsor: | Horizon Therapeutics, Inc. |
|---|---|
| Information provided by: | Horizon Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT00984815 |
Purpose
The purpose of this study is to evaluate the safety of long-term treatment with HZT-501, a fixed-dose combination oral tablet of 800 mg ibuprofen and 26.6 mg famotidine for patients that require long-term NSAID treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis Rheumatoid Arthritis Chronic Low Back Pain Chronic Regional Pain Syndrome Chronic Soft Tissue Pain |
Drug: HZT-501 |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
| Official Title: | Open-Label Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-Steroidal Anti-Inflammatory Drug Treatment |
| Estimated Enrollment: | 100 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | March 2011 |
| Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
HZT-501: Experimental
Open-label treatment with HZT-501
|
Drug: HZT-501
Fixed-dose combination oral tablet 800mg Ibuprofen/26.6 mg Famotidine taken three times per day
|
HZT-501, a fixed-dose combination of ibuprofen, a pain and inflammation relieving non-steroidal anti-inflammatory drug (NSAID), and famotidine, a histamine type 2 receptor antagonist (H2RA), is being developed for the treatment of patients with signs and symptoms of osteoarthritis, rheumatoid arthritis, mild to moderate pain or dysmenorrhea who are at risk of developing ibuprofen-associated upper gastrointestinal ulcers.
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Amy Y Grahn, MS | 224-406-2234 | agrahn@horizontherapeutics.com |
| Contact: Jeffrey W Sherman, MD | 224-383-3000 ext 103 | jsherman@horizontherapeutics.com |
| United States, Illinois | |
| Illinois Bone & Joint Institute | Recruiting |
| Morton Grove, Illinois, United States, 60053 | |
| Contact: Susan Nelson, RN 847-779-6770 snelson@ibji.com | |
| Principal Investigator: Alfonso Bello, MD | |
| University of Illinois Medical Center, Department of Medicine | Not yet recruiting |
| Chicago, Illinois, United States, 60612-7323 | |
| Contact: Karen Bednar, RN 312-996-1926 kbednar@uci.edu | |
| Principal Investigator: Jay Goldstein, MD | |
| United States, Pennsylvania | |
| Altoona Center for Clinical Research Altoona Arthritis | Recruiting |
| Duncansville, Pennsylvania, United States, 16635 | |
| Contact: Ashli Weyandt 814-693-0300 ext 154 ashliweyandt1125@yahoo.com | |
| Contact: Renea Weyandt 814-693-0300 reneaweyandt1125@yahoo.com | |
| Principal Investigator: Alan Kivitz, MD | |
| United States, Texas | |
| Metroplex Clinical Research Center | Recruiting |
| Dallas, Texas, United States, 75231 | |
| Contact: Sara Hibbard 214-424-0400 SHibbard@arthdocs.com | |
| Contact: Pricilla Diaz 214-424-0400 | |
| Principal Investigator: Sharad Lakhanpal, MD | |
| Principal Investigator: | Alfonso Bello, MD, FACP | Illinois Bone & Joint Institute |
More Information
| Responsible Party: | Horizon Therapeutics ( Jeffrey W. Sherman, MD ) |
| Study ID Numbers: | HZ-CA-401 |
| Study First Received: | September 23, 2009 |
| Last Updated: | September 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00984815 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
NSAID Chronic Pain Osteoarthritis Rheumatoid Arthritis |
|
Anti-Inflammatory Agents Osteoarthritis Physiological Effects of Drugs Arthritis, Rheumatoid Pain Signs and Symptoms Pathologic Processes Musculoskeletal Diseases Sensory System Agents Syndrome Arthritis Therapeutic Uses Connective Tissue Diseases Anti-Inflammatory Agents, Non-Steroidal |
Analgesics Autoimmune Diseases Disease Immune System Diseases Joint Diseases Nervous System Diseases Low Back Pain Rheumatic Diseases Back Pain Pharmacologic Actions Analgesics, Non-Narcotic Neurologic Manifestations Peripheral Nervous System Agents Antirheumatic Agents |