Effect of Octreotide on the Colonic Motility in Pediatric Patients

Phase 4

Completed

• Conditions: Colonic Motility Index; Constipation
• Interventions: Drug: Octreotide; Drug: Bisacodyl

• Registration Number: NCT01917773
• Lead Sponsor: Indiana University

Brief Summary

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.

Detailed Description

As mentioned above.

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-02
• Study First Submitted QC: 2013-08-05
• Study First Posted: 2013-08-07
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Results First Submitted: 2015-11-12
• Status Verified: 2015-12
• Results First Submitted QC: 2015-12-17
• Last Update Submitted: 2015-12-17
• Results First Posted: 2015-12-21
• Last Update Posted: 2015-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Octreotide	Bisacodyl	All patient received octreotide. We compared pre (fasting) and post octreotide colonic motility index.
Octreotide	Octreotide	All patient received octreotide. We compared pre (fasting) and post octreotide colonic motility index.

Primary Outcome Measures

Name	Time	Method
Compared Colonic Motility Index From Fasting to Post Octreotide Infusion	Average MI for all patients was calculated over 15-minutes, 30-minutes and 45- minutes before and after administration of octreotide.	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.

Trial Locations

Locations (1)

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