Back to resultsAn Exploratory Study Examining The Effects Of Taking GW679769 Once-Daily For 4 Days In Patients With Functional Dyspepsia
Primary Purpose
Nonulcer Dyspepsia
Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
GW679769 oral tablets
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Nonulcer Dyspepsia focused on measuring Functional Dyspepsia, Barostat, Stomach
Eligibility 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
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
GW679769
Placebo
Arm Description
120mg once a day
Placebo once a day
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00358410
Brief Title
An Exploratory Study Examining The Effects Of Taking GW679769 Once-Daily For 4 Days In Patients With Functional Dyspepsia
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonulcer Dyspepsia
Keywords
Functional Dyspepsia, Barostat, Stomach
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GW679769
Arm Type
Experimental
Arm Description
120mg once a day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo once a day
Intervention Type
Drug
Intervention Name(s)
GW679769 oral tablets
Intervention Description
2x GW679769 60mg tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo oral tablets to match experimental intervention
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
An Exploratory Study Examining The Effects Of Taking GW679769 Once-Daily For 4 Days In Patients With Functional Dyspepsia
We'll reach out to this number within 24 hrs