NCT00358410

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 31, 2006

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

February 8, 2017

Status Verified

February 1, 2017

Enrollment Period

7 months

First QC Date

July 27, 2006

Last Update Submit

February 6, 2017

Conditions

Nonulcer Dyspepsia

Keywords

Functional DyspepsiaBarostatStomach

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (2)

GW679769

EXPERIMENTAL

120mg once a day

Drug: GW679769 oral tablets

Placebo

PLACEBO COMPARATOR

Placebo once a day

Drug: Placebo

Interventions

GW679769 oral tabletsDRUG

2x GW679769 60mg tablets

GW679769
PlaceboDRUG

Placebo oral tablets to match experimental intervention

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Leuven, 3000, Belgium

Location

MeSH Terms

Interventions

casopitant

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2006

First Posted

July 31, 2006

Study Start

January 1, 2006

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

February 8, 2017

Record last verified: 2017-02

Locations

BE(1)