Status:
COMPLETED
An Exploratory Study Examining The Effects Of Taking GW679769 Once-Daily For 4 Days In Patients With Functional Dyspepsia
Lead Sponsor:
GlaxoSmithKline
Conditions:
Nonulcer Dyspepsia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 accommo...
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 d...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00358410
Start Date
January 1 2006
End Date
August 1 2006
Last Update
February 8 2017
Active Locations (1)
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1
GSK Investigational Site
Leuven, Belgium, 3000