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Effect of Octreotide on the Colonic Motility in Pediatric Patients
Plain-language guide to NCT01917773: phase 4 interventional trial of Octreotide, 13 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01917773
- Phase
- phase 4
- Status
- completed
- Start
- 2013-08
- Completion (planned or actual)
- 2014-06
- Participants
- 13 (actual)
- Design
- na, open label (everyone knows who gets what), supportive_care
- Conditions studied
- Colonic Motility Index; Constipation
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around Octreotide.
The research study is designed to test how a medication called octreotide affects the motility (contraction or squeezing) of the colon (large intestine).
It had 1 arm (groups): Octreotide (experimental).
All patient received octreotide. the researchers compared pre (fasting) and post octreotide colonic motility index.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 13 actual participants took part.
It was open to people of any sex aged from 1 Year up to 18 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: 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.
The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: • 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.
How the Study Was Run
The set-up was single-group and open-label.
Nothing was hidden in this open-label Octreotide study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2013-08 with completion listed for 2014-06.
It ran at 1 site in United States.
Its stated primary purpose is supportive care.
What Was Measured
Primary outcome: Compared Colonic Motility Index From Fasting to Post Octreotide Infusion.
What This Means in Plain Language
Put simply, this is a phase 4 trial of Octreotide in 13 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Octreotide compound page, all human trials.
Our Notes on the Compound
Octreotide: An 8-amino-acid somatostatin analog (Sandostatin, Mycapssa) used for acromegaly and certain hormone-secreting tumors.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.