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An Exploratory Study Examining The Effects Of Taking GW679769 Once-Daily For 4 Days In Patients With Functional Dyspepsia

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ClinicalTrials.gov Identifier: NCT00358410
Recruitment Status : Completed
First Posted : July 31, 2006
Last Update Posted : February 8, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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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.

Condition or disease Intervention/treatment Phase
Nonulcer Dyspepsia Drug: GW679769 oral tablets Drug: Placebo Phase 2

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : January 2006
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

Arms and Interventions
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Arm Intervention/treatment
Experimental: GW679769
120mg once a day
 Drug: GW679769 oral tablets
2x GW679769 60mg tablets
Placebo Comparator: Placebo
Placebo once a day
 Drug: Placebo
Placebo oral tablets to match experimental intervention


Outcome Measures
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Primary Outcome Measures :
  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. [ Time Frame: Three to Five Days ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00358410


Locations
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Belgium
GSK Investigational Site
Leuven, Belgium, 3000
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00358410    
Other Study ID Numbers: GW679769/904
First Posted: July 31, 2006    Key Record Dates
Last Update Posted: February 8, 2017
Last Verified: February 2017
Keywords provided by GlaxoSmithKline:
Functional Dyspepsia
Barostat
Stomach
Additional relevant MeSH terms:
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Dyspepsia
Signs and Symptoms, Digestive
Casopitant
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Gastrointestinal Agents
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action