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Effect of Octreotide on the Colonic Motility in Pediatric Patients

NCT ID: NCT01917773

Last Updated: 2015-12-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-06-30

Brief Summary

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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

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As mentioned above.

Conditions

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Colonic Motility Index Constipation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Octreotide

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

Group Type EXPERIMENTAL

Octreotide

Intervention Type DRUG

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

Bisacodyl

Intervention Type DRUG

Interventions

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Octreotide

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

Intervention Type DRUG

Bisacodyl

Intervention Type DRUG

Other Intervention Names

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post octreotide

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joseph Croffie

Role: STUDY_DIRECTOR

Riley Hospital for Children

Locations

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

Indianapolis, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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1305011397

Identifier Type: -

Identifier Source: org_study_id