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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00613106
Other study ID # HZ-CA-304
Secondary ID
Status Completed
Phase Phase 3
First received January 28, 2008
Last updated April 23, 2013
Start date September 2007
Est. completion date October 2008

Study information

Verified date April 2013
Source Horizon Pharma Ireland, Ltd., Dublin Ireland
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety of long-term treatment with HZT-501.


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.


Recruitment information / eligibility

Status Completed
Enrollment 179
Est. completion date October 2008
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 81 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Intervention

Drug:
HZT-501
Ibuprofen 800mg/famotidine 26.6 mg administered orally 3 times daily for 2 weeks
Ibuprofen
Ibuprofen 800mg administered orally 3 times daily for at least 28 weeks

Locations

Country Name City State
United States PRA International San Diego California

Sponsors (1)

Lead Sponsor Collaborator
Horizon Pharma Ireland, Ltd., Dublin Ireland

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 28 weeks Yes
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