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Caffeinated Gum to Prevent Post-Operative Ileus: A Prospective, Randomized, Placebo-controlled Trial

NCT02250924 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-06-04

No results posted yet for this study

Summary

This is a randomized, three-arm, double-blind, placebo-controlled, Phase III clinical trial of caffeinated gum and sugar-less gum in adult patients after an abdominal procedure. Patients will be randomized to receive placebo, sugar-less gum or caffeinated gum three times daily for 30 minutes starting the day following surgery until discharge or 24 hours after attainment of the primary endpoint.

Conditions

  • C.Surgical Procedure; Digestive System

Interventions

DIETARY_SUPPLEMENT

Caffeine

caffeinated gum

OTHER

Gum

Chewing gum

BEHAVIORAL

wear silicone bracelet

Subjects will put on bracelet to correspond with times for chewing gum

Sponsors & Collaborators

  • The Guthrie Clinic

    lead OTHER

Principal Investigators

  • Karim Sadik, MD · The Guthrie Clinic

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2020-05-31
Completion
2020-05-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02250924 on ClinicalTrials.gov