Effect of Octreotide on the Colonic Motility in Pediatric Patients

Indiana University

Status and phase

Completed

Phase 4

Conditions

Colonic Motility Index

Constipation

Treatments

Drug: Octreotide

Drug: Bisacodyl

Study type

Interventional

Funder types

Other

Identifiers

NCT01917773

1305011397

Details and patient eligibility

About

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.

Full description

As mentioned above.

Enrollment

13 patients

Sex

All

Ages

1 to 18 years old

Volunteers

No Healthy Volunteers

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