Trial Outcomes & Findings for Effect of Octreotide on the Colonic Motility in Pediatric Patients (NCT NCT01917773)
NCT ID: NCT01917773
Last Updated: 2015-12-21
Results Overview
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.
COMPLETED
PHASE4
13 participants
Average MI for all patients was calculated over 15-minutes, 30-minutes and 45- minutes before and after administration of octreotide.
2015-12-21
Participant Flow
All eligible patients referred for colonic manometry to the GI Motility Laboratory at Riley Hospital between Sep 2013 and June 2014. 24 patients were assessed for eligibility to participate in the study in the hospital. 8 patients were excluded, as they did not meet inclusion criteria. 3 participant refused enrollment.
Participant milestones
| Measure |
Octreotide
This was a non-randomized, single center, open label, and prospective study. Thirteen patients were enrolled in the study. All patient received Octreotide as per study protocol.
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Octreotide on the Colonic Motility in Pediatric Patients
Baseline characteristics by cohort
| Measure |
Octreotide
n=13 Participants
1. Fasting motility was recorded for at least 60 minutes.
2. Octreotide 1mcg/kg, maximum of 50mcg was administered subcutaneously (one hour after application of EMLA topical cream). Motility was then recorded for 45-60 minutes.
3. Patients were then offered a high-fat, high-energy meal as described elsewhere, and motility was recorded for 60 minutes.
4. Patients then received 1 to 2 doses of bisacodyl (0.2 mg/kg, maximum of 10 mg) through the motility catheter, and motility was recorded.
|
|---|---|
|
Age, Continuous
|
9.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Average MI for all patients was calculated over 15-minutes, 30-minutes and 45- minutes before and after administration of octreotide.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.
Outcome measures
| Measure |
15 Minutes
n=13 Participants
The MI for the 15 minutes before and after octreotide infusion was measured.
|
30 Minutes
n=13 Participants
The MI for the 30 minutes before and after octreotide infusion was measured.
|
45 Minutes
n=13 Participants
The MI for the 45 minutes before and after octreotide infusion was measured.
|
|---|---|---|---|
|
Compared Colonic Motility Index From Fasting to Post Octreotide Infusion
pre-octreotide
|
6.03 mm Hg
Interval 5.35 to 6.72
|
6.89 mm Hg
Interval 6.14 to 7.64
|
7.73 mm Hg
Interval 7.01 to 8.45
|
|
Compared Colonic Motility Index From Fasting to Post Octreotide Infusion
post-octreotide
|
5.32 mm Hg
Interval 4.42 to 6.23
|
6.71 mm Hg
Interval 5.91 to 7.52
|
7.53 mm Hg
Interval 6.78 to 8.28
|
Adverse Events
All Patients
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All Patients
n=13 participants at risk
All 13 patient received octreotide injection. Motility Index (MI) (mm Hg) for the 15 minutes before and after octreotide infusion was measured.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Mild discomfort with administration of subcutaneous octreotide
|
46.2%
6/13
|
|
Gastrointestinal disorders
mild abdominal discomfort
|
23.1%
3/13
|
Additional Information
Joseph Croffie
Riley Hospital for Children, Indiana University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place