An Exploratory Study Examining The Effects Of Taking GW679769 Once-Daily For 4 Days In Patients With Functional Dyspepsia

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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An Exploratory Study to Investigate the Effects of the NK1 Antagonist GW679769, 60 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 Center, Placebo-controlled, Double-blind, Randomised, Two-period Crossover Study

Conditions
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Nonulcer Dyspepsia

Intervention / Treatment
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* Drug: GW679769 oral tablets
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GW679769<br>120mg once a day | Drug: GW679769 oral tablets<br>* 2x GW679769 60mg tablets<br>|
| Placebo Comparator: Placebo<br>Placebo once a day | Drug: Placebo<br>* Placebo oral tablets to match experimental intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | Three to Five Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of gastric emptying as measured by dual breath test.Thresholds for perception and discomfort during gastric distension by gastric barostat. |  | Three to Five days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stomach, Functional Dyspepsia, Barostat