An Exploratory Study Examining The Effects Of Taking GW679769 Once-Daily For 4 Days In Patients With Functional Dyspepsia
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
13 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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