Caffeinated Gum to Prevent Post-Operative Ileus: A Prospe... | NCT02250924

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

NCT02250924

Sponsor

The Guthrie Clinic

Status

Withdrawn

Last Update Posted

Jun 4, 2020Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

C.Surgical Procedure; Digestive System

Interventions

Caffeine
Gum
wear silicone bracelet

Countries

United States

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

Jun 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Investigator decision - clinical practice change

Expanded Access Info

Start Date

Jan 2017Estimated

Primary Completion Date

May 2020Actual

Completion Date

May 28, 2020Actual

First Submitted Date

Sep 22, 2014

First Submission Date that Met QC Criteria

Sep 24, 2014

First Posted Date

Sep 26, 2014Estimated

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

Jun 1, 2020

Last Update Posted Date

Jun 4, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Subjects will wear a silicone bracelet for 30 minutes 3 times daily at 8 am, 12 pm and 4 pm.	Behavioral: wear silicone bracelet
Sugar-less Gum	Sham Comparator	Subjects will chew one stick of sugar-less gum for 30 minutes 3 times daily at 8 am, 12 pm and 4 pm.	Other: Gum
Caffeinated Gum	Experimental	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.	Dietary Supplement: Caffeine Other: Gum

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Caffeine	Dietary Supplement	caffeinated gum	Caffeinated Gum
Gum

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean time to GI function recovery (GI-3)		An expected average of 5 days

Secondary Outcomes

Measure	Description	Time Frame
Mean length of postoperative hospitalization		Up to 30 days
Rate of postoperative ileus		Up to 30 days
Adverse event rates

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Karim Sadik, MD	The Guthrie Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Guthrie Clinic		Sayre	Pennsylvania	18840	United States

Intervention Browse Module

MeSH Terms

ID	Term
D002110	Caffeine
D002638	Chewing Gum

Ancestor Terms

ID	Term
D014970	Xanthines
D000470	Alkaloids
D006571	Heterocyclic Compounds
D011688	Purinones

Browse Leaves

Not provided

Browse Branches

Not provided