CLINICAL TRIALS PROFILE FOR IBUPROFEN AND FAMOTIDINE

All Clinical Trials for IBUPROFEN AND FAMOTIDINE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00450216 ↗	Efficacy and Safety Study of HZT-501 in Subjects Requiring Nonsteroidal Anti-Inflammatory Drug (NSAID) Treatment	Completed	Horizon Pharma Ireland, Ltd., Dublin Ireland	Phase 3	2007-03-01	The purpose of this study is to evaluate whether HZT-501 is effective in reducing the rate of development of ibuprofen-associated ulcers in patients who require long-term daily use of ibuprofen.
NCT00450658 ↗	Efficacy and Safety Study of HZT-501 in Reducing the Risk of Ibuprofen-associated Ulcers	Completed	Horizon Pharma Ireland, Ltd., Dublin Ireland	Phase 3	2007-03-01	The purpose of this study is to evaluate whether HZT-501 is effective in reducing the rate of development of ibuprofen-associated ulcers in patients who require long-term daily use of ibuprofen.
NCT00613106 ↗	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)	Completed	Horizon Pharma Ireland, Ltd., Dublin Ireland	Phase 3	2007-09-01	The purpose of this study is to evaluate the safety of long-term treatment with HZT-501.
NCT00984815 ↗	Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-steroidal Anti-inflammatory Drug Treatment	Completed	Horizon Pharma Ireland, Ltd., Dublin Ireland	Phase 3	2009-09-01	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.
NCT01563185 ↗	Open-label Safety and Pharmacokinetic Study of DUEXIS® (Ibuprofen and Famotidine) Tablets in Juvenile Idiopathic Arthritis	Completed	Pediatric Rheumatology Collaborative Study Group	Phase 4	2012-04-01	The primary objective of this Phase 4, multi-center, open-label study is to evaluate the safety and tolerability of DUEXIS in Juvenile Idiopathic Arthritis (JIA) patients aged 10 years to 16 years, 11 months, treated up to 24 weeks. The secondary objectives are to evaluate the PK characteristics of DUEXIS in JIA patients and to evaluate the signs and symptoms of JIA in patients aged 10 years to 16 years, 11 months receiving DUEXIS for up to 24 weeks.

Clinical Trial Conditions for IBUPROFEN AND FAMOTIDINE

Condition Name

Condition Name for IBUPROFEN AND FAMOTIDINE
Intervention	Trials
Rheumatoid Arthritis	2
Chronic Low Back Pain	2
Chronic Regional Pain Syndrome	2
Chronic Soft Tissue Pain	2

Condition MeSH

Condition MeSH for IBUPROFEN AND FAMOTIDINE
Intervention	Trials
Arthritis	2
Osteoarthritis	2
Nociceptive Pain	2
Low Back Pain	2

Clinical Trial Locations for IBUPROFEN AND FAMOTIDINE

Trials by Country

Trials by Country for IBUPROFEN AND FAMOTIDINE
Location	Trials
United States	9

Trials by US State

Trials by US State for IBUPROFEN AND FAMOTIDINE
Location	Trials
Texas	2
Pennsylvania	2
North Carolina	1
Massachusetts	1
Louisiana	1

Clinical Trial Progress for IBUPROFEN AND FAMOTIDINE

Clinical Trial Phase

Clinical Trial Phase for IBUPROFEN AND FAMOTIDINE
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	4

Clinical Trial Status

Clinical Trial Status for IBUPROFEN AND FAMOTIDINE
Clinical Trial Phase	Trials
Completed	5
Terminated	1

Clinical Trial Sponsors for IBUPROFEN AND FAMOTIDINE

Sponsor Name

Sponsor Name for IBUPROFEN AND FAMOTIDINE
Sponsor	Trials
Horizon Pharma Ireland, Ltd., Dublin Ireland	5
Pediatric Rheumatology Collaborative Study Group	1
Duke University	1

Sponsor Type

Sponsor Type for IBUPROFEN AND FAMOTIDINE
Sponsor	Trials
Industry	5
Other	2