Advertisement

Topics

Efficacy and Safety Study of HZT-501 in Reducing the Risk of Ibuprofen-Associated Ulcers

2014-08-27 03:39:31 | BioPortfolio

Summary

The purpose of this study is to evaluate whether HZT-501 is effective in reducing the rate of development of ibuprofen-associated ulcers in patients who require long-term daily use of ibuprofen.

Description

HZT-501 is a combination product including ibuprofen and the acid reducing agent famotidine. The study is designed to determine whether the combination product reduces the rate of ulcer development in subjects who require long-term daily use of ibuprofen.

Subjects will be assigned randomly, in approximately a 2:1 ratio, to treatment with either HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg) or ibuprofen (800 mg) three times daily for a 24 week treatment period or until they develop either an endoscopically-diagnosed upper gastrointestinal ulcer and/or prohibitive toxicity. Subjects will visit the study center for Screening and at Weeks 4, 8, 16, and 24. Physical exams will be performed, and clinical laboratory measurements made, at selected times during the study. Endoscopic exams will be performed during Screening and at Weeks 8, 16, and 24. Subjects will be contacted four weeks following study completion.

Study Design

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

Conditions

Peptic Ulcer

Intervention

Ibuprofen/famotidine, Ibuprofen

Location

Medici Group Central Contact
King of Prussia
Pennsylvania
United States
19406

Status

Completed

Source

Horizon Therapeutics, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:39:31-0400

Clinical Trials [619 Associated Clinical Trials listed on BioPortfolio]

Efficacy and Safety Study of HZT-501 in Subjects Requiring Nonsteroidal Anti-Inflammatory Drug (NSAID) Treatment

The purpose of this study is to evaluate whether HZT-501 is effective in reducing the rate of development of ibuprofen-associated ulcers in patients who require long-term daily use of ibup...

Famotidine Compared With Pantoprazole to Prevent Recurrent Aspirin-Induced Peptic Ulcer/Erosion

Low-dose aspirin can prevent cerebral and cardiovascular accidents in individuals with symptomatic atherothrombotic disease, but its use is frequently limited by gastrointestinal side effe...

To Determine Blood Concentrations of Ibuprofen and Caffeine in a Tablet Against Ibuprofen Alone From Another Tablet

The objective of the trial is to compare to combination of 400 mg ibuprofen and 100 mg caffeine against 400 mg ibuprofen alone under fed conditions

Double-Blind Follow-on Safety Study of HZT-501 in Subjects Who Have Completed Participation in HZ-CA-301 or HZ-CA-303

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

Efficacy, Safety, and Pharmacokinetics of Intravenous Ibuprofen in Adult Febrile Patients

The primary objective of this study is to evaluate the efficacy of intravenous ibuprofen on reducing fever at 4 hours.

PubMed Articles [362 Associated PubMed Articles listed on BioPortfolio]

Diagnosis and Treatment of Peptic Ulcer Disease.

Peptic ulcer disease continues to be a source of significant morbidity and mortality worldwide. Approximately two-thirds of patients found to have peptic ulcer disease are asymptomatic. In symptomatic...

Intra- abdominal sepsis from a perforated duodenal ulcer-Management of a difficult surgical abdomen.

Peptic ulcer perforation is a common surgical emergency that is a complication of 9% of patients with peptic ulcer disease (Kjetil et al., 2015 [1]). Despite advances in the management of peptic ulcer...

Multistep Interactions between Ibuprofen and Lipid Membranes.

Ibuprofen (IBU) interacts with phosphatidylcholine membranes in three distinct steps as a function of concentration. In a first step (

The comparison of monopolar hemostatic forceps with soft coagulation versus hemoclip for peptic ulcer bleeding: a randomized trial (with video).

Although various methods are used in the treatment of peptic ulcer bleeding, there is not a standard recommended approach. The choice depends on multiple factors such as location of the ulcer, clinica...

Simulation-based suggestions to improve ibuprofen dosing for patent ductus arteriosus in preterm newborns.

Ibuprofen is the drug of choice for treatment of patent ductus arteriosus (PDA). There is accumulating evidence that current ibuprofen-dosing regimens for PDA treatment are inadequate. We aimed to pro...

Medical and Biotech [MESH] Definitions

Bleeding from a PEPTIC ULCER that can be located in any segment of the GASTROINTESTINAL TRACT.

Penetration of a PEPTIC ULCER through the wall of DUODENUM or STOMACH allowing the leakage of luminal contents into the PERITONEAL CAVITY.

Ulcer that occurs in the regions of the GASTROINTESTINAL TRACT which come into contact with GASTRIC JUICE containing PEPSIN and GASTRIC ACID. It occurs when there are defects in the MUCOSA barrier. The common forms of peptic ulcers are associated with HELICOBACTER PYLORI and the consumption of nonsteroidal anti-inflammatory drugs (NSAIDS).

A nonsteroidal anti-inflammatory agent with analgesic properties used in the therapy of rheumatism and arthritis.

An IBUPROFEN-type anti-inflammatory analgesic and antipyretic. It is used in the treatment of rheumatoid arthritis and osteoarthritis.

More From BioPortfolio on "Efficacy and Safety Study of HZT-501 in Reducing the Risk of Ibuprofen-Associated Ulcers"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Alzheimer's Disease
Of all the types of Dementia, Alzheimer's disease is the most common, affecting around 465,000 people in the UK. Neurons in the brain die, becuase  'plaques' and 'tangles' (mis-folded proteins) form in the brain. People with Al...

Peptic Ulcer Disease
Peptic Ulcer Disease - stomach ulcer, duodenal ulcers used to refer to all types of peptic ulcers. A peptic ulcer is an erosion in a segment of the Gastrointestinal (GI) muscularis mucosae, typically in the stomach (gastric ulcer) or the first few cent...


Searches Linking to this Trial