Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00450658
Status:
COMPLETED
Last Update Posted:
2013-04-29
First Post:
2007-03-19
Brief Title:
Efficacy and Safety Study of HZT-501 in Reducing the Risk of Ibuprofen-associated Ulcers
Sponsor:
Horizon Pharma Ireland Ltd Dublin Ireland
Organization:
Horizon Pharma Ireland Ltd Dublin Ireland
Study Overview
Official Title:
A Randomized Double-Blind Phase 3 Study of the Efficacy and Safety of HZT-501 in Subjects Requiring NSAID Treatment
Status:
COMPLETED
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
HZT-501 is a combination product including ibuprofen and the acid reducing agent famotidine The study is designed to determine whether the combination product reduces the rate of ulcer development in subjects who require long-term daily use of ibuprofen
Subjects will be assigned randomly in approximately a 21 ratio to treatment with either HZT-501 ibuprofen 800 mgfamotidine 266 mg or ibuprofen 800 mg three times daily for a 24 week treatment period or until they develop either an endoscopically-diagnosed upper gastrointestinal ulcer andor prohibitive toxicity Subjects will visit the study center for Screening and at Weeks 4 8 16 and 24 Physical exams will be performed and clinical laboratory measurements made at selected times during the study Endoscopic exams will be performed during Screening and at Weeks 8 16 and 24 Subjects will be contacted four weeks following study completion
Subjects will be assigned randomly in approximately a 21 ratio to treatment with either HZT-501 ibuprofen 800 mgfamotidine 266 mg or ibuprofen 800 mg three times daily for a 24 week treatment period or until they develop either an endoscopically-diagnosed upper gastrointestinal ulcer andor prohibitive toxicity Subjects will visit the study center for Screening and at Weeks 4 8 16 and 24 Physical exams will be performed and clinical laboratory measurements made at selected times during the study Endoscopic exams will be performed during Screening and at Weeks 8 16 and 24 Subjects will be contacted four weeks following study completion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None