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Completed

NCT Number: NCT00613106

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)

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

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Key information

Conditions

Osteoarthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Autonomic Nervous System Diseases Chronic Low Back Pain Chronic Regional Pain Syndrome Chronic Soft Tissue Pain Complex Regional Pain Syndromes Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Rheumatic Diseases Rheumatoid Arthritis Skin and Connective Tissue Diseases

Age range

40 year–81 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

PRA International

San Diego, California, 92122, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HZT-501

Drug

Ibuprofen 800mg/famotidine 26.6 mg administered orally 3 times daily for 2 weeks

Ibuprofen

Drug

Ibuprofen 800mg administered orally 3 times daily for at least 28 weeks

Primary outcomes

  1. Number of Participants With Treatment Emergent Adverse Events

    Time frame: 28 weeks

    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.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study 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)

Acronym: HZ-CA-304

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 12, 2008
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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