TerminatedPhase 4

Effect of Tegaserod on Gastric Emptying in Patients With Diabetic Gastroparesis

Stopped: This study was terminated early as a result of regulatory action suspending tegaserod use in 2007

United States40 participantsStarted 2007-01

Plain-language summary

This study will assess gastric emptying in patients with symptoms of diabetic gastroparesis treated with tegaserod over 2 weeks.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion Criteria: * Females and males 18 to 75 years of age * History of type I or type II diabetes mellitus for more than 3 years * History of upper gastrointestinal symptoms consistent with diabetic gastroparesis * Hemoglobin A1c \< 9.5% * Delayed gastric emptying Exclusion Criteria: * Abnormal endoscopy finding that can explain the presence of gastroparesis symptoms * Medical conditions affecting gastric emptying * A clinically significant medical condition that would interfere with the patient completing the trial * Clinically significant abnormal creatinine level * Known allergies to the same class of drug and/or allergies to eggs * Severe obesity Other protocol-defined inclusion/exclusion criteria may apply.

What they're measuring

Proportion of patients treated with tegaserod that improve gastric emptying at Week 2 as compared with baseline via a solid phase technetium gastric emptying time (GET)

Trial details

NCT IDNCT00390975

SponsorNovartis

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-03

View on ClinicalTrials.gov More Gastroparesis trials