Assessment of the Effect of Tegaserod (2 mg Tid and 6 mg... | NCT00142974

Studies
Assessment of the Effect of Tegaserod (2 mg Tid and 6 mg Tid) on Dyspeptic Symptoms in Diabetic Patients With Symptoms of Diabetic Gastropathy

NCT00142974

Sponsor

Novartis

Status

Terminated

Last Update Posted

Apr 20, 2012Estimated

Enrollment

120

Phase

Phase 2

Conditions

Diabetic Gastropathy

Interventions

Tegaserod

Countries

Switzerland

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

Apr 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

This study was terminated early in April 2005 due to low patient enrollment

Expanded Access Info

Not provided

Start Date

May 2004

Primary Completion Date

Apr 2005Actual

Completion Date

Apr 2005Actual

First Submitted Date

Aug 31, 2005

First Submission Date that Met QC Criteria

Aug 31, 2005

First Posted Date

Sep 2, 2005Estimated

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

Apr 19, 2012

Last Update Posted Date

Apr 20, 2012Estimated

Description Module

Brief Summary

This study is being done to evaluate the safety, tolerability and satisfactory relief of tegaserod against dyspeptic symptoms in diabetic patients with symptoms of diabetic gastropathy.

Detailed Description

Not provided

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120

Name	Type	Description	Arm Group Labels	Other Names
Tegaserod	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction in weekly mean of a daily composite diabetic gastropathy dyspeptic symptom severity score throughout 6 weeks of treatment.

Secondary Outcomes

Measure	Description	Time Frame
Weekly global measure of dyspeptic symptom relief.
Weekly mean severity of individual dyspeptic symptoms (nausea, vomiting, retching, epigastric/stomach, discomfort/pain, postprandial fullness, bloating, early satiety).

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

History of Type 1 or insulin-requiring Type 2 diabetes for at least 3 years
GI symptoms for at least 2 months before entering study

Exclusion Criteria:

Very high body weight
Significant diarrhea
Ulcers

Symptom severity score collected via diary 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

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Novartis	Basel	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Novartis		Basel		4056	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D013272	Stomach Diseases

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided