NCT00171457

Brief Summary

Investigate the role of tegaserod in modulating gastric sensitivity to mechanical distention of the stomach

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2005

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

October 10, 2007

Status Verified

October 1, 2007

First QC Date

September 12, 2005

Last Update Submit

October 9, 2007

Conditions

HeartburnDyspepsia

Keywords

functional heartburndyspepsiamalefemalevisceral sensitivity

Outcome Measures

Primary Outcomes (1)

  • To determine if tegaserod 6 mg b.i.d modulates gastric sensitivity to mechanical distention of the stomach

Secondary Outcomes (7)

  • 1) Comparing effects at end of treatment compared to baseline:

  • To verify that tegaserod modulates esophageal sensitivity to esophageal distention

  • To determine if tegaserod improves individual dyspeptic symptoms of epigastric pain/discomfort

  • To determine if tegaserod improves heartburn and/or regurgitation

  • To determine if tegaserod is preferred by patients with functional heartburn & accompanying dyspepsia & gastric mechanical sensitivity over placebo

  • +2 more secondary outcomes

Interventions

TegaserodDRUG

Eligibility Criteria

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

You may qualify if:

  • Male or female subjects at least 18 years of age.
  • Subjects willing to undergo multiple nasogastric intubations.
  • Patients with functional heartburn will need to meet ROME II criteria.
  • Patients with symptoms consistent with dyspepsia (epigastric pain/discomfort characterized by bloating, postprandial fullness and early satiety)

You may not qualify if:

  • Subjects with clinically significant diarrhea or a diagnosis of diarrhea-predominant IBS.
  • Subjects with a diagnosis of IBD, Barrett's esophagus, esophageal stricture or ring, or previous or current history of ulcer disease.
  • Subjects with Diffuse Esophageal Spasm or Achalasia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oklahoma Foundation for Digestive Research

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (1)

  • Miner PB Jr, Rodriguez-Stanley S, Proskin HM, Kianifard F, Bottoli I. Tegaserod in patients with mechanical sensitivity and overlapping symptoms of functional heartburn and functional dyspepsia. Curr Med Res Opin. 2008 Aug;24(8):2159-72. doi: 10.1185/03007990802222832. Epub 2008 Jun 17.

    PMID: 18561877DERIVED

MeSH Terms

Conditions

HeartburnDyspepsia

Interventions

tegaserod

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Novartis

    Novartis

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

April 1, 2005

Study Completion

September 1, 2006

Last Updated

October 10, 2007

Record last verified: 2007-10

Locations

US(1)