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

NCT ID: NCT02250924

Last Updated: 2020-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2020-05-28

Brief Summary

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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.

Detailed Description

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Conditions

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C.Surgical Procedure; Digestive System

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Subjects will wear a silicone bracelet for 30 minutes 3 times daily at 8 am, 12 pm and 4 pm.

Group Type PLACEBO_COMPARATOR

wear silicone bracelet

Intervention Type BEHAVIORAL

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

Sugar-less Gum

Subjects will chew one stick of sugar-less gum for 30 minutes 3 times daily at 8 am, 12 pm and 4 pm.

Group Type SHAM_COMPARATOR

Gum

Intervention Type OTHER

Chewing gum

Caffeinated Gum

Subjects will chew one stick of caffeinated gum (100mg caffeine per stick) for 30 minutes 3 times daily at 8 am, 12 pm and 4 pm.

Group Type EXPERIMENTAL

Caffeine

Intervention Type DIETARY_SUPPLEMENT

caffeinated gum

Gum

Intervention Type OTHER

Chewing gum

Interventions

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Caffeine

caffeinated gum

Intervention Type DIETARY_SUPPLEMENT

Gum

Chewing gum

Intervention Type OTHER

wear silicone bracelet

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Abdominal procedure (Laparoscopic or open, occurring electively), American Society of Anesthesiologists (ASA) physical status score ≤ 3, Glasgow Coma Score (GCS) ≥ 15.

Exclusion Criteria

* ASA physical status score of \>3, GCS \< 15, complete bowel obstruction, history of cardiac arrhythmia, history of phenylketonuria, alcohol abuse. substance abuse dentures
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Guthrie Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karim Sadik, MD

Role: PRINCIPAL_INVESTIGATOR

The Guthrie Clinic

Locations

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The Guthrie Clinic

Sayre, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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GC1410-55

Identifier Type: -

Identifier Source: org_study_id

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