NCT00142974

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2004

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

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

May 1, 2004

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
Last Updated

April 20, 2012

Status Verified

April 1, 2012

Enrollment Period

11 months

First QC Date

August 31, 2005

Last Update Submit

April 19, 2012

Conditions

Diabetic Gastropathy

Keywords

Diabetes, tegaserod, gastropathy

Outcome Measures

Primary Outcomes (1)

  • Reduction in weekly mean of a daily composite diabetic gastropathy dyspeptic symptom severity score throughout 6 weeks of treatment.

Secondary Outcomes (2)

  • 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).

Interventions

TegaserodDRUG

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • Very high body weight
  • Significant diarrhea
  • Ulcers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis

Basel, 4056, Switzerland

Location

MeSH Terms

Conditions

Diabetes MellitusStomach Diseases

Interventions

tegaserod

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Novartis

    Basel

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2005

First Posted

September 2, 2005

Study Start

May 1, 2004

Primary Completion

April 1, 2005

Study Completion

April 1, 2005

Last Updated

April 20, 2012

Record last verified: 2012-04

Locations

CH(1)