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)

Rheumatoid Arthritis Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00613106
• Other study ID #: HZ-CA-304
• 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

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Chronic Low Back Pain
• Chronic Regional Pain Syndrome
• Chronic Soft Tissue Pain
• Low Back Pain
• Osteoarthritis
• Rheumatoid Arthritis

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