Effect of Octreotide on the Colonic Motility in Pediatric Patients

• ClinicalTrials.gov Identifier: NCT01917773
• Recruitment Status: Completed
• First Posted: August 7, 2013
• Results First Posted: December 21, 2015
• Last Update Posted: December 21, 2015
• Sponsor: Indiana University
• Information provided by (Responsible Party): Indiana University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Colonic Motility Index; Constipation	Drug: Octreotide; Drug: Bisacodyl	Phase 4

Detailed Description:

As mentioned above.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 13 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Effect of Octreotide on the Colonic Motility in Pediatric Patients
• Study Start Date: August 2013
• Actual Primary Completion Date: June 2014
• Actual Study Completion Date: June 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Compared Colonic Motility Index From Fasting to Post Octreotide Infusion [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 1 Year to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Indiana

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

Indianapolis, Indiana, United States, 46202

Sponsors and Collaborators

Indiana University

Investigators

• Study Director: Joseph Croffie; Riley Hospital for Children

More Information

• Responsible Party: Indiana University
• ClinicalTrials.gov Identifier: NCT01917773
• Other Study ID Numbers: 1305011397
• First Posted: August 7, 2013
• Results First Posted: December 21, 2015
• Last Update Posted: December 21, 2015
• Last Verified: December 2015

Additional relevant MeSH terms:

Constipation; Signs and Symptoms, Digestive; Octreotide; Bisacodyl; Gastrointestinal Agents; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Cathartics; Laxatives