Effect of Tegaserod on Orocecal Transit in Elderly Chroni... | NCT00348634

Studies
Effect of Tegaserod on Orocecal Transit in Elderly Chronic Constipation Patients

NCT00348634

Sponsor

Novartis

Status

Terminated

Last Update Posted

Mar 4, 2016Estimated

Enrollment

60Estimated

Phase

Phase 4

Conditions

Chronic Constipation

Interventions

Tegaserod

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Terminated early due to regulatory action suspending tegaserod use in 2007

Expanded Access Info

Not provided

Start Date

Jul 2006

Primary Completion Date

Apr 2007Actual

Completion Date

Apr 2007Actual

First Submitted Date

Jul 3, 2006

First Submission Date that Met QC Criteria

Jul 3, 2006

First Posted Date

Jul 4, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 2, 2016

Last Update Posted Date

Mar 4, 2016Estimated

Name	Class
Temple University	OTHER
University of Michigan	OTHER

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Name	Type	Description	Arm Group Labels	Other Names
Tegaserod	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Orocecal transit: Time of radioactive marker to reach the cecum using scintigraphy

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Other protocol-defined inclusion/exclusion criteria may apply.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Henry Parkman, MD	Temple	Study Chair
William Chey, MD	University of Michigan	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Arkansas Gastroenterology, PA		North Little Rock	Arizona	72117	United States
University of Michigan Medical Center

Condition Browse Module

MeSH Terms

ID	Term
D003248	Constipation

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided