Back to results

Effect of Octreotide on the Colonic Motility in Pediatric Patients

Primary Purpose

Colonic Motility Index, Constipation

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Octreotide

Bisacodyl

About this trial

This is an interventional supportive care trial for Colonic Motility Index

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Octreotide

Arm Description

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

Outcomes

Primary Outcome Measures

Compared Colonic Motility Index From Fasting to Post Octreotide Infusion

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01917773

First Posted

August 2, 2013

Last Updated

December 17, 2015

Sponsor

Indiana University

1. Study Identification

Unique Protocol Identification Number

NCT01917773

Brief Title

Effect of Octreotide on the Colonic Motility in Pediatric Patients

Official Title

Effect of Octreotide on the Colonic Motility in Pediatric Patients

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

August 2013 (undefined)

Primary Completion Date

June 2014 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Indiana University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 octreotide can increase contraction and movement in the colon.

Detailed Description

As mentioned above.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colonic Motility Index, Constipation

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Octreotide

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Octreotide

Other Intervention Name(s)

post octreotide

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Bisacodyl

Primary Outcome Measure Information:

Title

Compared Colonic Motility Index From Fasting to Post Octreotide Infusion

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joseph Croffie

Organizational Affiliation

Riley Hospital for Children

Official's Role

Study Director

Facility Information:

Facility Name

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

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Effect of Octreotide on the Colonic Motility in Pediatric Patients

We'll reach out to this number within 24 hrs