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

NCT ID: NCT00358410

Last Updated: 2017-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2006-08-31

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

Conditions

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Nonulcer Dyspepsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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GW679769

120mg once a day

Group Type EXPERIMENTAL

GW679769 oral tablets

Intervention Type DRUG

2x GW679769 60mg tablets

Placebo

Placebo once a day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo oral tablets to match experimental intervention

Interventions

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GW679769 oral tablets

2x GW679769 60mg tablets

Intervention Type DRUG

Placebo

Placebo oral tablets to match experimental intervention

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Leuven, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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GW679769/904

Identifier Type: -

Identifier Source: org_study_id

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