ColonoscopyPhase 2NCT01398098
Measurement of Gastric Emptying During and After COLOKIT® Intake
A Phase 2 study testing Sodium phosphate in people with Colonoscopy, run by Laboratoires Mayoly Spindler at 1 site in France.
Trial summary
Ultra-sound study to assess changes in intragastric volume after bowel preparation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colonoscopy
- What is being tested?
- Sodium phosphate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2011to Sep 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gastric Emptying Time Assessment During Bowel Preparation With COLOKIT®
Ultra-sound study to assess changes in intragastric volume after bowel preparation.
- Conditions
- Colonoscopy
- Being tested
- Sodium phosphate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium phosphateDrug
32 tablets
| Study group | Role | What they receive |
|---|---|---|
| COLOKIT® | Experimental | Not described Receives: Drug: Sodium phosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with a residual antral volume lower than 20 mL
Measured: after 2nd treatment regimen intake
Secondary outcomes (3)
Adverse events
Measured: After drug intake
Acceptability of COLOKIT®.
Measured: After drug intake
Colonoscopy results
Measured: After colonoscopy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2011 (estimated)
- Study startOct 2011
- Primary completionMay 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoires Mayoly Spindler
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stanislas CHAUSSADE, Professor, Principal investigator, Cochin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01398098
- Sponsor's protocol ID
- FCOL 111
- Other IDs
- 2011-002953-80
- Status last verified
- Nov 2012
- First submitted
- 13 Jul 2011
- Last updated
- 29 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25309090
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Emptying Time Assessment During Bowel Preparation With COLOKIT®
- ClinicalTrials.gov ID
- NCT01398098
- Acronym / sponsor ID
- FCOL 111
- Conditions
- Colonoscopy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Laboratoires Mayoly SpindlerIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 20 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ultra-sound study to assess changes in intragastric volume after bowel preparation.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COLOKIT® | Experimental | Drug: Sodium phosphate |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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®.
Key exclusion criteria (19 listed)
- Women pregnant or likely to be (without contraception) or nursing.
- Subject having any of the following diseases or conditions:
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 |
|---|---|---|
| Sodium phosphate32 tablets | Drug | COLOKIT® |
Primary outcome
Percentage of patients with a residual antral volume lower than 20 mL
Time frame: after 2nd treatment regimen intake
3 secondary outcomes
Adverse events
Time frame: After drug intake
Acceptability of COLOKIT®.
Time frame: After drug intake
Colonoscopy results
Time frame: After colonoscopy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2012.
- Derived from this study: PubMed 25309090Coriat 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.
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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.
Stanislas CHAUSSADE, Professor principal investigator
Cochin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sodium phosphate in people with Colonoscopy, run by Laboratoires Mayoly Spindler at 1 site in France.
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 6 inclusion and 19 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 29 Nov 2012. 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 France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of patients with a residual antral volume lower than 20 mL (time frame: after 2nd treatment regimen intake). 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 NCT01398098, which also lists 1 linked publication.
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 29 Nov 2012.