NCT00348634

Brief Summary

This study will evaluate the effects of tegaserod on orocecal and colonic transit in patients over 65 years with chronic constipation.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2006

Shorter than P25 for phase_4

Geographic Reach
1 country

3 active sites

Status
terminated

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

July 1, 2006

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

March 4, 2016

Status Verified

March 1, 2016

Enrollment Period

9 months

First QC Date

July 3, 2006

Last Update Submit

March 2, 2016

Conditions

Chronic Constipation

Keywords

Constipation, Tegaserod, orocecal transit, colonic transit, gastric emptying

Outcome Measures

Primary Outcomes (1)

  • Orocecal transit: Time of radioactive marker to reach the cecum using scintigraphy

Secondary Outcomes (1)

  • Whole gut transit and stomach emptying: Following 2 weeks of treatment, the rate of transit of food through the colon and stomach will be measured using scintigraphy

Interventions

TegaserodDRUG

Eligibility Criteria

Age65 Years+
Sexall
Age GroupsOlder Adult (65+)

You may qualify if:

  • Male \& Females aged 65 and older
  • Patients must meet the criteria for chronic idiopathic constipation for at least 12 weeks
  • Patients must have had a colonoscopy within the past 5 years
  • Patients must pass a balloon expulsion test at screening
  • Patients must be able to comply and understand the use of a diary

You may not qualify if:

  • Patients with a clinically significant medical condition that would interfere with the patient completing the trial
  • Patients with loose stools at least once per week
  • Patients with IBS
  • Known allergies to the same class of drug and/or allergies to eggs
  • Patients who require the use of manual maneuvers to have a bowel movement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Arkansas Gastroenterology, PA

North Little Rock, Arizona, 72117, United States

Location

University of Michigan Medical Center

Ann Arbor, Michigan, 48109-0362, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

Constipation

Interventions

tegaserod

Condition Hierarchy (Ancestors)

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

Study Officials

  • Henry Parkman, MD

    Temple

    STUDY CHAIR

  • William Chey, MD

    University of Michigan

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2006

First Posted

July 4, 2006

Study Start

July 1, 2006

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

March 4, 2016

Record last verified: 2016-03

Locations

US(3)