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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02250924
Recruitment Status : Withdrawn (Investigator decision - clinical practice change)
First Posted : September 26, 2014
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
The Guthrie Clinic

Tracking Information
First Submitted Date  ICMJE September 22, 2014
First Posted Date  ICMJE September 26, 2014
Last Update Posted Date June 4, 2020
Estimated Study Start Date  ICMJE January 2017
Actual Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2014)
Mean time to GI function recovery (GI-3) [ Time Frame: An expected average of 5 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2014)
  • Mean length of postoperative hospitalization [ Time Frame: Up to 30 days ]
  • Rate of postoperative ileus [ Time Frame: Up to 30 days ]
  • Adverse event rates [ Time Frame: Up to 30 days postoperative ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Caffeinated Gum to Prevent Post-Operative Ileus: A Prospective, Randomized, Placebo-controlled Trial
Official Title  ICMJE Caffeinated Gum to Prevent Post-Operative Ileus: A Prospective, Randomized, Placebo-controlled Trial
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE C.Surgical Procedure; Digestive System
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Subjects will wear a silicone bracelet for 30 minutes 3 times daily at 8 am, 12 pm and 4 pm.
    Intervention: Behavioral: wear silicone bracelet
  • Sham Comparator: 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.
    Intervention: Other: Gum
  • Experimental: 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.
    Interventions:
    • Dietary Supplement: Caffeine
    • Other: Gum
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: June 1, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: September 24, 2014)
450
Actual Study Completion Date  ICMJE May 28, 2020
Actual Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02250924
Other Study ID Numbers  ICMJE GC1410-55
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The Guthrie Clinic
Study Sponsor  ICMJE The Guthrie Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Karim Sadik, MD The Guthrie Clinic
PRS Account The Guthrie Clinic
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP