Effect of Octreotide on the Colonic Motility in Pediatric Patients

The research study is designed to test how a medication called octreotide affects the motility (contraction or squeezing) of the colon (large intestine). Investigators are investigating whether octreotide can increase contraction and movement in the colon.

Study Overview

• Status: Completed
• Conditions: Constipation; Colonic Motility Index
• Intervention / Treatment: Drug: Bisacodyl; Drug: Octreotide

Detailed Description

As mentioned above.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Motility Laboratory, Division of Pediatric Gastroenterology, Hepatology and Nutrition at the James Whitcomb Riley Hospital for Children,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female and undergoing colonic manometry for a routinely accepted indication including: evaluation of chronic constipation, unexplained abdominal distension (Should have had previous diagnostic work up), recurrent fecal impaction, post Hirschsprung's disease repair, chronic intestinal pseudo-obstruction, or suspected colonic dysmotility of any other cause.
• Children aged 12 months or older who are undergoing colonic motility under the supervision of Dr. Joseph Croffie at Riley Hospital.
• In the investigator's judgment, parent(s)/guardian(s) is mentally competent to provide informed consent to participate in the study.

Exclusion Criteria:

• • Subjects with known or suspected allergy to octreotide.

  • Subjects with known prolonged corrected QT interval (QTc) Syndrome or highest risk QTc-Prolonging Agents (including mifepristone).
  • Subjects with known history of ventricular arrhythmia.
  • Subjects with history of any organ transplant who are taking cyclosporine at the time of the motility study.
  • Subjects with history of small bowel transplant.
  • Subjects less than 12 months old.
  • Subjects with severe renal impairment
  • Subjects with severe hepatic impairment
  • Subjects taking bromocriptine, insulin, oral hypoglycemic agents, beta blockers, calcium channel blockers, quinidine, terfenadine, pimozide, sildenafil, tadalafil, and any agents to control fluid and electrolyte imbalance

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Octreotide; All patient received octreotide. We compared pre (fasting) and post octreotide colonic motility index.	Drug: Bisacodyl; Drug: Octreotide; Average MI for all patients was calculated over 15-minutes, 30-minutes and 45- minutes before and after administration of octreotide; Other Names: post octreotide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compared Colonic Motility Index From Fasting to Post Octreotide Infusion	Colonic motility was measured using a solid-state catheter. The catheter had 36 sensors spaced 5-cm apart for the first 15 sensors and 1-cm apart for the remaining sensors. Pressures were transmitted to a transducer and recorded on a personal computer system (Medical Measurement Systems USA, Dover, NH). Motility index (MI) was calculated using the Medical Measurement Systems computer program. The MI represents the area under the curve of the pressure tracing for a certain period (21). The MI was calculated for each channel. The MIs from all of the channels were then averaged to give each patient 1 average MI for the particular period under study. In this study, MI was calculated for the periods of 15, 30, and 45 minutes before and after infusion of octreotide. MI is reported as millimeters of mercury (mmHg) per 15, 30, or 45 minutes.	Average MI for all patients was calculated over 15-minutes, 30-minutes and 45- minutes before and after administration of octreotide.

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Study Director: Joseph Croffie, Riley Hospital for Children

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: August 2, 2013
• First Submitted That Met QC Criteria: August 5, 2013
• First Posted (Estimate): August 7, 2013

Study Record Updates

• Last Update Posted (Estimate): December 21, 2015
• Last Update Submitted That Met QC Criteria: December 17, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation; Antineoplastic Agents; Gastrointestinal Agents; Antineoplastic Agents, Hormonal; Cathartics; Laxatives; Octreotide; Bisacodyl
• Other Study ID Numbers: 1305011397