Measurement of Gastric Emptying During and After COLOKIT®... | NCT01398098

Studies
Measurement of Gastric Emptying During and After COLOKIT® Intake

NCT01398098

Sponsor

Laboratoires Mayoly Spindler

Status

Completed

Last Update Posted

Nov 29, 2012Estimated

Enrollment

30Actual

Phase

Phase 2

Conditions

Colonoscopy

Interventions

Sodium phosphate

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2011-002953-80	EudraCT Number

Status Module

Record Verification Date

Nov 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2011

Primary Completion Date

May 2012Actual

Completion Date

Sep 2012Actual

First Submitted Date

Jul 13, 2011

First Submission Date that Met QC Criteria

Jul 19, 2011

First Posted Date

Jul 20, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 28, 2012

Last Update Posted Date

Nov 29, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Label	Type	Description	Intervention Names
COLOKIT®	Experimental		Drug: Sodium phosphate

Name	Type	Description	Arm Group Labels	Other Names
Sodium phosphate	Drug	32 tablets	COLOKIT®

Measure	Description	Time Frame
Percentage of patients with a residual antral volume lower than 20 mL		after 2nd treatment regimen intake

Measure	Description	Time Frame
Adverse events		After drug intake
Acceptability of COLOKIT®.		After drug intake
Colonoscopy results

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject who signed an informed consent to participate in the trial.
Subject affiliated with Social Security
Men and women aged 18 to 75 years.
Subject with an indication of scheduled outpatient colonoscopy.
colonoscopy performed within six hours after the second sequence COLOKIT®.
Subject able to swallow tablets.

Exclusion Criteria:

Women pregnant or likely to be (without contraception) or nursing.
Subject having any of the following diseases or conditions:
- allergy or hypersensitivity to the product tested or any of its excipients,
- nausea, vomiting or abdominal pain,
- clinically significant renal failure,
- primary hyperparathyroidism associated with hypercalcemia,
- congestive heart failure,
- ascites,
- a known or suspected bowel obstruction,
- megacolon (congenital or acquired)
- intestinal perforation,
- ileus,
- an inflammatory disease or suspected inflammatory bowel disease,
- swallowing disorders,
- known digestive motor disorders (gastroparesis, scleroderma, mega-esophagus),
- diabetes mellitus (insulin or non insulin-dependent)
- a history of gastric surgery (partial or total)
- a contraindication to the anesthesia required for the completion of the colonoscopy,
- Any clinical condition which, in the opinion of the investigator, would not allow the subject to perform the test in good conditions.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Stanislas CHAUSSADE, Professor	Cochin Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Cochin Hospital		Paris		75014	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25309090	Derived	Coriat R, Polin V, Oudjit A, Henri F, Dhooge M, Leblanc S, Delchambre C, Esch A, Tabouret T, Barret M, Prat F, Chaussade S. Gastric emptying evaluation by ultrasound prior colonoscopy: an easy tool following bowel preparation. World J Gastroenterol. 2014 Oct 7;20(37):13591-8. doi: 10.3748/wjg.v20.i37.13591.