Back to resultsDouble-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)
Primary Purpose
Osteoarthritis, Rheumatoid Arthritis, Chronic Low Back Pain
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
HZT-501
Ibuprofen
Sponsored by
About this trial
This is an interventional prevention trial for Osteoarthritis
Eligibility 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.
Sites / Locations
- PRA International
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
HZT-501
Ibuprofen
Arm Description
HZT-501: ibuprofen 800mg/famotidine 26.6mg
Ibuprofen 800mg
Outcomes
Primary Outcome Measures
Number of Participants With Treatment Emergent Adverse Events
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00613106
First Posted
January 28, 2008
Last Updated
April 23, 2013
Sponsor
Horizon Pharma Ireland, Ltd., Dublin Ireland
1. Study Identification
Unique Protocol Identification Number
NCT00613106
Brief Title
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)
Acronym
HZ-CA-304
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 Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Horizon Pharma Ireland, Ltd., Dublin Ireland
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety of long-term treatment with HZT-501.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Rheumatoid Arthritis, Chronic Low Back Pain, Chronic Regional Pain Syndrome, Chronic Soft Tissue Pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
179 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HZT-501
Arm Type
Experimental
Arm Description
HZT-501: ibuprofen 800mg/famotidine 26.6mg
Arm Title
Ibuprofen
Arm Type
Active Comparator
Arm Description
Ibuprofen 800mg
Intervention Type
Drug
Intervention Name(s)
HZT-501
Intervention Description
Ibuprofen 800mg/famotidine 26.6 mg administered orally 3 times daily for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Intervention Description
Ibuprofen 800mg administered orally 3 times daily for at least 28 weeks
Primary Outcome Measure Information:
Title
Number of Participants With Treatment Emergent Adverse Events
Description
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.
Time Frame
28 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
81 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
PRA International
City
San Diego
State/Province
California
ZIP/Postal Code
92122
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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)
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