Nonulcer Dyspepsia
Conditions
Keywords
Functional Dyspepsia, Barostat, Stomach
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
Interventions
2x GW679769 60mg tablets
DRUGPlacebo
Placebo oral tablets to match experimental intervention
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Belgium
Outcome results
None listed