An Exploratory Study Examining The Effects Of Taking GW679769 Once-Daily For 4 Days In Patients With Functional Dyspesia - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00358410

Purpose

This study was designed is to examine the idea that GW679769 has an effect on three of the pathophysiological disturbances reported in patients with Functional Dyspepsia (FD): impaired stomach accommodation to a meal, delayed stomach emptying, and visceral hypersensitivity to distension.

Condition	Intervention	Phase
Functional Dyspepsia	Drug: GW679769 oral tablets	Phase I

MedlinePlus related topics: Indigestion

Drug Information available for: GW679769

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacodynamics Study
Official Title:	An Exploratory Study to Investigate the Effects of the NK1 Antagonist GW679769, 120 mg Once Daily for 4 Days, on Gastric Accommodation, Gastric Emptying and Gastric Distension-Induced Perception and Discomfort in Adult Male and Female Patients With Functional Dyspepsia, in a Single-Centre, Placebo-Controlled, Double-Blind, Randomised, Two-Period Crossover Study

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

To identify whether GW679769 has an effect on gastric accommodation to a meal, as measured by gastric barostat in male and female patients with FD. Meal induced fundus relaxation as measured by gastric barostat.

Secondary Outcome Measures:

Rate of gastric emptying as measured by dual breath test. Thresholds for perception and discomfort during gastric distension by gastric barostat.

Estimated Enrollment:	15
Study Start Date:	September 2005

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Functional dyspepsia as diagnosed according to the Rome II criteria
Must had a one month trial (full dose) of proton pump inhibitor treatment within the last 6 months, during a symptomatic period, that produced no lasting response, although this may not be required for those patients who have no symptoms of heartburn and do not present pain-predominant dyspepsia symptoms. Such decision will be left to the Principal Investigator's discretion.
Patients who are non-smokers or smokers who smoke up to 20 cigarettes per day

Exclusion criteria:

Active or history of peptic ulcer disorder
History of major abdominal surgery
History of underlying psychiatric illness, or current active psychiatric morbidity
Pregnant or nursing women

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00358410

Locations

Belgium
GSK Clinical Trials Call Center
Leuven, Belgium, B - 3000

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, Prof. Dr

GlaxoSmithKline

More Information

Study ID Numbers:	GW679769/904
Study First Received:	July 27, 2006
Last Updated:	April 16, 2007
ClinicalTrials.gov Identifier:	NCT00358410
Health Authority:	Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Keywords provided by GlaxoSmithKline:

Functional Dyspepsia
Stomach
Barostat

Study placed in the following topic categories:

Signs and Symptoms
Stomach Diseases
Digestive System Diseases
Signs and Symptoms, Digestive
Dilatation, Pathologic

Gastrointestinal Diseases
Gastroenteritis
Dyspepsia
Gastritis

ClinicalTrials.gov processed this record on January 16, 2009