Effect of Octreotide on the Colonic Motility in Pediatric Patients

Constipation Clinical Trial

Official title:

Effect of Octreotide on the Colonic Motility in Pediatric Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01917773
• Other study ID #: 1305011397
• Status: Completed
• Phase: Phase 4
• First received: August 2, 2013
• Last updated: December 17, 2015
• Start date: August 2013
• Est. completion date: June 2014

Study information

• Verified date: December 2015
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

As mentioned above.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 18 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Colonic Motility Index
• Constipation

Intervention

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

Locations

Country	Name	City	State
United States	Motility Laboratory, Division of Pediatric Gastroenterology, Hepatology and Nutrition at the James Whitcomb Riley Hospital for Children,	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No