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)

Last updated: November 21, 2024
Sponsor: Amgen
Overall Status: Completed

Phase

3

Condition

Chronic Pain

Complex Regional Pain Syndrome- Type 1 (Crps-i)

Reflex Sympathetic Dystrophy Syndrome (Rsds)

Treatment

Ibuprofen

HZT-501

Clinical Study ID

NCT00613106
HZ-CA-304
  • Ages 40-81
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Expected to continue to require daily administration of an NSAID for at least thecoming 6 months.

  • Subject completed the 24-week Treatment period of either Horizon Protocol HZ-CA-301or HZ-CA-303

Exclusion

Exclusion Criteria:

  • Subject didn't meet all of the Inclusion and Exclusion Criteria for Horizon ProtocolHZ-CA-301 or HZ-CA-303

  • Subject developed or experienced any of the following while on either HZ-CA-301 orHZ-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 willdetermine if you meet all of the criteria.

Study Design

Total Participants: 179
Treatment Group(s): 2
Primary Treatment: Ibuprofen
Phase: 3
Study Start date:
September 01, 2007
Estimated Completion Date:
October 31, 2008

Study 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.

Study with completed results acquired from Horizon in 2024.

Connect with a study center

  • PRA International

    San Diego, California 92122
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.