Status:
COMPLETED
Effect of Octreotide on the Colonic Motility in Pediatric Patients
Lead Sponsor:
Indiana University
Conditions:
Colonic Motility Index
Constipation
Eligibility:
All Genders
1-18 years
Phase:
PHASE4
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 octreo...
Detailed Description
As mentioned above.
Eligibility Criteria
Inclusion
- 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
- • 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
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01917773
Start Date
August 1 2013
End Date
June 1 2014
Last Update
December 21 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Motility Laboratory, Division of Pediatric Gastroenterology, Hepatology and Nutrition at the James Whitcomb Riley Hospital for Children,
Indianapolis, Indiana, United States, 46202