Effect of Octreotide on the Colonic Motility in Pediatric Patients

NCT01917773 | Completed Phase 4 Results DMC

• 1 other identifier: 1305011397
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonic Motility Index; Constipation

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Octreotide

EXPERIMENTAL

All patient received octreotide. We compared pre (fasting) and post octreotide colonic motility index.

Drug: Octreotide; Drug: Bisacodyl

Interventions

Octreotide DRUG

Average MI for all patients was calculated over 15-minutes, 30-minutes and 45- minutes before and after administration of octreotide

Also known as: post octreotide

Octreotide

Bisacodyl DRUG

Octreotide

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Motility Laboratory, Division of Pediatric Gastroenterology, Hepatology and Nutrition at the James Whitcomb Riley Hospital for Children,

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Constipation

Interventions

Octreotide; Bisacodyl

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Cresols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Joseph Croffie
• Organization: Riley Hospital for Children, Indiana University

jcroffie@iupui.edu

317-944-3774

Study Officials

• Joseph Croffie

  Riley Hospital for Children

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2013
• First Posted: August 7, 2013
• Study Start: August 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: December 21, 2015
• Results First Posted: December 21, 2015

Record last verified: 2015-12

Locations

US (1)