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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00358410
First received: July 27, 2006
Last updated: January 27, 2011
Last verified: January 2011
  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
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: See Detailed Description

Resource links provided by NLM:


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. [ Time Frame: Three to Five Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of gastric emptying as measured by dual breath test.Thresholds for perception and discomfort during gastric distension by gastric barostat. [ Time Frame: Three to Five days ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: January 2006
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GW679769
120mg once a day
Drug: GW679769 oral tablets
2x GW679769 60mg tablets
Other Name: GW679769 oral tablets
Placebo Comparator: Placebo
Placebo once a day
Drug: Placebo
Placebo oral tablets to match experimental intervention

Detailed 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

  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 Investigational Site
Leuven, Belgium, 3000
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: E.D. Derilus; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00358410     History of Changes
Other Study ID Numbers: GW679769/904
Study First Received: July 27, 2006
Last Updated: January 27, 2011
Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Keywords provided by GlaxoSmithKline:
Functional Dyspepsia
Barostat
Stomach

Additional relevant MeSH terms:
Dyspepsia
Gastritis
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on April 23, 2014