GSK Investigational Site
Leuven, 3000, Belgium
Completed
NCT Number: NCT00358410
An Exploratory Study Examining The Effects Of Taking GW679769 Once-Daily For 4 Days In Patients With Functional Dyspepsia
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.
Completed
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Notify MeKey information
Conditions
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
About this study
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
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
GW679769 oral tablets
Drug2x GW679769 60mg tablets
Placebo
DrugPlacebo oral tablets to match experimental intervention
Primary outcomes
-
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 outcomes
-
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
Sponsors and collaborators
Lead sponsor
GlaxoSmithKline
Industry
Registry information
Official study 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
Important dates
- Study start
- 2006
- Primary completion
- 2006
- Study completion
- 2006
- First posted
- Jul 31, 2006
- Registry last updated
- Feb 8, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.