Effect of Octreotide on the Colonic Motility in Pediatric Patients

NCTNCT01917773Other id1305011397

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Overview

Status: Completed
Phase: Phase 4
Enrollment: 13 participants (actual)
Sponsor: Indiana University · Other
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
United States
Start: Aug 2013
Primary completion: Jun 2014
Completion: Jun 2014
First posted: 7 Aug 2013 (estimated)
Last update posted: 21 Dec 2015 (estimated)
Conditions: Colonic Motility Index · Constipation

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201320142015

Ph 4
Effect of Octreotide on the Colonic Motility in Pediatric Patients
NCT01917773
Aug 2013 to Jun 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

OctreotideDrug
BisacodylDrug

Arms1

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

Primary outcomes1

Outcomes the sponsor listed as primary.

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.
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

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

Compared Colonic Motility Index From Fasting to Post Octreotide Infusion

Group	Value (mm Hg)
15 Minutes	6.03
30 Minutes	6.89
45 Minutes	7.73

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
All PatientsAll 13 patient received octreotide injection. Motility Index (MI) (mm Hg) for the 15 minutes before and after octreotide infusion was measured.	–	0 / 13	7 / 13

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 1 Year up to 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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