Effect of Octreotide on the Colonic Motility in Pediatric Patients



Status:Completed
Conditions:Constipation
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:1 - 18
Updated:4/21/2016
Start Date:August 2013
End Date:June 2014

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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.

As mentioned above.

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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