Colonic Motility IndexPhase 4NCT01917773

Effect of Octreotide on the Colonic Motility in Pediatric Patients

A Phase 4 study testing Octreotide and Bisacodyl in people with Colonic Motility Index and Constipation, run by Indiana University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 1 year to 18 years
Conditions the study is for: Colonic Motility Index, Constipation
What is being tested?: Octreotide and Bisacodyl
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 1 siteUnited States
Study dates: Aug 2013to Jun 2014
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 1 year to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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.

Who cannot join

• 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.

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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

Trial locations and contacts

1 site in 1 country.

United States1 site

Motility Laboratory, Division of Pediatric Gastroenterology, Hepatology and Nutrition at the James Whitcomb Riley Hospital for Children,
Indianapolis, Indiana, 46202

Other trials in United States

About this study

Read the detailed description

As mentioned above.

Conditions: Colonic Motility Index, Constipation
Being tested: Octreotide, Bisacodyl
Medical subject headings: Constipation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01917773
Study group	Role	What they receive
Octreotide	Experimental	All patient received octreotide. We compared pre (fasting) and post octreotide colonic motility index. Receives: Drug: Octreotide; Drug: Bisacodyl

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2013Jun 2014

First posted7 Aug 2013 (estimated)
Study startAug 2013
Primary completionJun 2014
Study completionJun 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Colonic Motility IndexStudies of the same condition, open and under way.
More trials run by Indiana UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01917773
Sponsor's protocol ID: 1305011397
Status last verified: Dec 2015
First submitted: 2 Aug 2013
Last updated: 21 Dec 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Study at a glance

From the registry record, last updated by the sponsor on 21 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Octreotide on the Colonic Motility in Pediatric Patients
ClinicalTrials.gov ID: NCT01917773
Acronym / sponsor ID: 1305011397
Conditions: Colonic Motility Index, Constipation
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: Indiana UniversityUniversity, hospital or other
Study start: Aug 2013
Primary completion: Jun 2014 (actual)
Study completion: Jun 2014 (actual)
First posted: 7 Aug 2013 (estimated)
Results: Posted 21 Dec 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

As mentioned above.

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Octreotide	Experimental	Drug: Octreotide, Drug: BisacodylAll patient received octreotide. We compared pre (fasting) and post octreotide colonic motility index.

Who may qualify

Ages: 1 year to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (9 listed)

• Subjects with known or suspected allergy to octreotide.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OctreotideAlso: post octreotideAverage MI for all patients was calculated over 15-minutes, 30-minutes and 45- minutes before and after administration of octreotide	Drug	Octreotide
Bisacodyl	Drug	Octreotide

Primary outcome

Compared Colonic Motility Index From Fasting to Post Octreotide Infusion
Time frame: 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.

Results and safety

Results posted to the registry on 21 Dec 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Octreotide	13	13

Primary outcome: Compared Colonic Motility Index From Fasting to Post Octreotide Infusion

Time frame: Average MI for all patients was calculated over 15-minutes, 30-minutes and 45- minutes before and after administration of octreotide.. Mean (95% Confidence Interval). Unit: mm Hg

Measure	15 Minutes n = 13	30 Minutes n = 13	45 Minutes n = 13
pre-octreotide	6.03 (5.35 to 6.72)	6.89 (6.14 to 7.64)	7.73 (7.01 to 8.45)
post-octreotide	5.32 (4.42 to 6.23)	6.71 (5.91 to 7.52)	7.53 (6.78 to 8.28)

15 Minutes: p = 0.087, Wilcoxon signed rank test
30 Minutes: p = 0.552, Wilcoxon signed rank test
45 Minutes: p = 0.807, Wilcoxon signed rank test

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Patients	0 of 13 (0%)	7 of 13 (53.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Joseph Croffie study director

Riley Hospital for Children

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Octreotide and Bisacodyl in people with Colonic Motility Index and Constipation, run by Indiana University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compared Colonic Motility Index From Fasting to Post Octreotide Infusion (time frame: Average MI for all patients was calculated over 15-minutes, 30-minutes and 45- minutes before and after administration of octreotide.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01917773.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2015.