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

Nonulcer Dyspepsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00358410
• Other study ID #: GW679769/904
• Status: Completed
• Phase: Phase 2
• First received: July 27, 2006
• Last updated: February 6, 2017
• Start date: January 2006
• Est. completion date: August 2006

Study information

• Verified date: February 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyspepsia
• Nonulcer Dyspepsia

Intervention

Drug:
• GW679769 oral tablets
2x GW679769 60mg tablets
• Placebo
Placebo oral tablets to match experimental intervention

Locations

Country	Name	City	State
Belgium	GSK Investigational Site	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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