MedDataX Logo

Measurement of Gastric Emptying During and After COLOKIT® Intake

NCT ID: NCT01398098

Last Updated: 2012-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Ultra-sound study to assess changes in intragastric volume after bowel preparation.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colonoscopy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

COLOKIT®

Group Type EXPERIMENTAL

Sodium phosphate

Intervention Type DRUG

32 tablets

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sodium phosphate

32 tablets

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

1. Women pregnant or likely to be (without contraception) or nursing.
2. 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Laboratoires Mayoly Spindler

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Stanislas CHAUSSADE, Professor

Role: PRINCIPAL_INVESTIGATOR

Cochin Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cochin Hospital

Paris, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 25309090 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2011-002953-80

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

FCOL 111

Identifier Type: -

Identifier Source: org_study_id