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

This study is currently recruiting participants.
Verified November 2016 by The Guthrie Clinic
Sponsor:
ClinicalTrials.gov Identifier:
NCT02250924
First Posted: September 26, 2014
Last Update Posted: November 29, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
The Guthrie Clinic
  Purpose
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.

Condition Intervention Phase
C.Surgical Procedure; Digestive System Dietary Supplement: Caffeine Other: Gum Behavioral: wear silicone bracelet Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Caffeinated Gum to Prevent Post-Operative Ileus: A Prospective, Randomized, Placebo-controlled Trial

Further study details as provided by The Guthrie Clinic:

Primary Outcome Measures:
  • Mean time to GI function recovery (GI-3) [ Time Frame: An expected average of 5 days ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 435
Study Start Date: June 2015
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Subjects will wear a silicone bracelet for 30 minutes 3 times daily at 8 am, 12 pm and 4 pm.
Behavioral: wear silicone bracelet
Subjects will put on bracelet to correspond with times for chewing gum
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.
Other: Gum
Chewing 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.
Dietary Supplement: Caffeine Other: Gum
Chewing gum

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02250924


Contacts
Contact: Karim Sadik, MD 570-887-2681 sadik_karim@guthrie.org
Contact: Alexander Johnston, MD 570-887-3585 johnston_alexander@guthrie.org

Locations
United States, Pennsylvania
The Guthrie Clinic Recruiting
Sayre, Pennsylvania, United States, 18840
Sponsors and Collaborators
The Guthrie Clinic
Investigators
Principal Investigator: Karim Sadik, MD The Guthrie Clinic
  More Information

Responsible Party: The Guthrie Clinic
ClinicalTrials.gov Identifier: NCT02250924     History of Changes
Other Study ID Numbers: GC1410-55
First Submitted: September 22, 2014
First Posted: September 26, 2014
Last Update Posted: November 29, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents