Colon CleansingPhase 3NCT01840553
Efficacy and Safety Study of Sodium Phosphate Tablets vs PEG for Bowel Cleansing
A Phase 3 study testing oral sodium phosphate tablets and polyethylene glycol in people with Colon Cleansing, run by Laboratoires Mayoly Spindler at 19 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of sodium phosphate tablets compared to split dose of 4 liters of PEG used in adults for bowel cleansing prior to colonoscopy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colon Cleansing
- What is being tested?
- oral sodium phosphate tablets and polyethylene glycol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 461 participants
- Where
- 19 sitesin 3 countries
- Study dates
- May 2013to Mar 2014
- Phase
- Phase 3
- 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
- Men and women aged from 18 to 75 years (included).
- Scheduled for a colonoscopy as an outpatient.
- Normal renal function
Who cannot join
- Having a disease or condition as follows:
- repeated episodes of nausea and vomiting
- abdominal pain due to severe infection or requiring surgery
- clinically significant abnormal electrolytes values
- congestive heart failure, unstable angina pectoris or recent myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass surgery within previous 3 months
- known/suspected bowel obstruction, megacolon, ileus or intestinal perforation, or gastroparesis,
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- inflammatory bowel disease,
- history of gastric stapling or bypass procedure or gastric retention
- Sodium phosphate preparation taken within the past three weeks prior to colonoscopy.
- Known allergy to any of the active ingredients or excipients of the study drugs.
- History of phenylketonuria
Trial locations and contacts
19 sites in 3 countries.
19 sites in 3 countries
France8 sites
Hôpital Avicenne
Bobigny
Polyclinique Bordeaux Nord Aquitaine
Bordeaux
Hopital Edouard Herriot
Lyon
Groupe Hospitalier Intercommunal Le Raincy-Montfermeil
Montfermeil
CHU Hotel Dieu
Nantes
Hopital l'Archet
Nice
CHU Cochin
Paris
Clinique Saint-Jean Languedoc
Toulouse
Spain7 sites
Complejo Hospitalario de A Coruna
A Coruña
Hospital Clinic de Barcelona
Barcelona
Hospital de Fuenlabrada
Fuenlabrada
Hospital 12 de Octubre
Madrid
Hospital Clinico San Carlos
Madrid
Hospital Universitarion Gregorio Maranon
Madrid
Clinica Universidad de Navarra
Pamplona
Germany4 sites
Sana Klinikum Lichtenberg
Berlin
Kreisklinik Biberach
Biberach
Klinikum Heidenheim
Heidenheim
Medizinische Klinik und Poliklinik II Munchen
München
About this study
Official title: A Randomized Assessor-blinded Multicenter International Study Investigating Efficacy Patients Acceptance Safety and Tolerability of Sodium Phosphate Tablets Compared to Split Dose Polyethylene Glycol for Colon Cleansing Prior to Colonoscopy
The purpose of this study is to evaluate the efficacy and safety of sodium phosphate tablets compared to split dose of 4 liters of PEG used in adults for bowel cleansing prior to colonoscopy.
- Conditions
- Colon Cleansing
- Being tested
- oral sodium phosphate tablets, polyethylene glycol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral sodium phosphate tabletsDrug
polyethylene glycolDrug
| Study group | Role | What they receive |
|---|---|---|
| polyethylene glycol | Active comparator | 4 Liters of PEG administered split in 2 doses Receives: Drug: polyethylene glycol |
| oral sodium phosphate tablets | Experimental | oral Sodium Phosphate tablets administered as 32 tablets (20+12) with 2 Liters of liquid Receives: Drug: oral sodium phosphate tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall quality of bowel cleansing
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2013 (estimated)
- Study startMay 2013
- Primary completionMar 2014
- Study completionMar 2014
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 Colon CleansingStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 461 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoires Mayoly Spindler
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01840553
- Sponsor's protocol ID
- ICOL121
- Other IDs
- 2012-005115-13
- Status last verified
- Nov 2013
- First submitted
- 23 Apr 2013
- Last updated
- 24 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Chaussade S, Schmocker C, Toulemonde P, Munoz-Navas M, O'Mahony V, Henri F. Phosphate tablets or polyethylene glycol for preparation to colonoscopy? A multicentre non-inferiority randomized controlled trial. Surg Endosc. 2017 May;31(5):2166-2173. doi: 10.1007/s00464-016-5214-1. Epub 2016 Nov 18.
PubMed 27864718
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Assessor-blinded Multicenter International Study Investigating Efficacy Patients Acceptance Safety and Tolerability of Sodium Phosphate Tablets Compared to Split Dose Polyethylene Glycol for Colon Cleansing Prior to Colonoscopy
- ClinicalTrials.gov ID
- NCT01840553
- Acronym / sponsor ID
- ICOL121
- Conditions
- Colon Cleansing
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 461 participants (actual)
- Lead sponsor
- Laboratoires Mayoly SpindlerIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 25 Apr 2013 (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.
The purpose of this study is to evaluate the efficacy and safety of sodium phosphate tablets compared to split dose of 4 liters of PEG used in adults for bowel cleansing prior to colonoscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| polyethylene glycol | Active comparator | Drug: polyethylene glycol4 Liters of PEG administered split in 2 doses |
| oral sodium phosphate tablets | Experimental | Drug: oral sodium phosphate tabletsoral Sodium Phosphate tablets administered as 32 tablets (20+12) with 2 Liters of liquid |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women aged from 18 to 75 years (included).
- Scheduled for a colonoscopy as an outpatient.
- Normal renal function
Key exclusion criteria (11 listed)
- Having a disease or condition as follows:
- Sodium phosphate preparation taken within the past three weeks prior to colonoscopy.
- Known allergy to any of the active ingredients or excipients of the study drugs.
- History of phenylketonuria
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 |
|---|---|---|
| oral sodium phosphate tablets | Drug | oral sodium phosphate tablets |
| polyethylene glycol | Drug | polyethylene glycol |
Primary outcome
overall quality of bowel cleansing
Time frame: day 1
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 24 Mar 2014.
- Derived from this study: PubMed 27864718Chaussade S, Schmocker C, Toulemonde P, Munoz-Navas M, O'Mahony V, Henri F. Phosphate tablets or polyethylene glycol for preparation to colonoscopy? A multicentre non-inferiority randomized controlled trial. Surg Endosc. 2017 May;31(5):2166-2173. doi: 10.1007/s00464-016-5214-1. Epub 2016 Nov 18.
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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.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing oral sodium phosphate tablets and polyethylene glycol in people with Colon Cleansing, run by Laboratoires Mayoly Spindler at 19 sites in 3 countries.
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 11 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 24 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in France, Spain, Germany. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
overall quality of bowel cleansing (time frame: day 1). 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 NCT01840553, 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 24 Mar 2014.