Subjects Undergoing a Complete Exploratory Diagnostic Colonoscopy for the First Time.Phase 3NCT01065857
Safety and Efficacy Study of CitraFleet (Sodium Picosulphate) as an Evacuating Treatment Prior to Colonoscopy.
A Phase 3 study testing Sodium picosulphate, light magnesium oxide and anhydride citric acid. and Polyethylene glycol, KCl, NaCl, sodium sulphate anhydrous and sodium bicarbonate. in people with Subjects Undergoing a Complete Exploratory Diagnostic Colonoscopy for the First Time., run by Laboratorios Casen-Fleet S.L.U. at 15 sites in Spain.
Trial summary
The purpose of this study is to determine any significant differences in the efficacy and acceptability between CitraFleet and Klean Prep® (polyethylene glycol) for the preparation of gastrointestinal subjects undergoing a colon examination. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Subjects Undergoing a Complete Exploratory Diagnostic Colonoscopy for the First Time.
- What is being tested?
- Sodium picosulphate, light magnesium oxide and anhydride citric acid. and Polyethylene glycol, KCl, NaCl, sodium sulphate anhydrous and sodium bicarbonate.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 547 participants
- Where
- 15 sitesSpain
- Study dates
- Jan 2010to Feb 2011
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who are between 18 and 80 years of age.
- Subjects undergoing complete colonoscopy and therefore require prior preparation with either Klean Prep® or CitraFleet.
- Subjects capable of maintaining appropriate oral hydration during the intestinal preparation process.
- Subjects that have provided written informed consent.
- Subjects in whom the use of any of the study drugs (KleanPrep®,CitraFleet) is not contraindicated.
- Subjects who can communicate with the study personnel and comply with study requirements.
- Subjects undergoing a complete exploratory diagnostic colonoscopy for the first time.
Who cannot join
- Severe renal insufficiency.
- Ascites.
- Congestive heart failure.
- Gastrointestinal obstruction, gastric retention, intestinal perforation and/or ileus.
- Megacolon and/or toxic colitis.
- Nausea and/or vomiting and/or abdominal pain.
Show all 16Show fewer
- Severe dehydration.
- Hypermagnesemia.
- Rhabdomyolysis.
- Pregnant women.
- Subjects who have participated in a clinical trial in the previous 30 days.
- Abdominal surgery for any acute process (for example acute appendicitis).
- Active inflammatory intestinal disease.
- Known allergy to any of the active ingredients or excipients of the study drugs.
- Subjects not providing written informed consent.
- Subjects not complying with all of the inclusion criteria.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Spain15 sites
H. Universitari Vall´d Hebron
Barcelona, Barcelona, 08035
H. Clínic
Barcelona, Barcelona, 08036
H. Basurto
Bilbao, Vizcaya, 48013
H. General Universitario Reina Sofía
Córdoba, Córdoba, 14004
H. Universitario Virgen de las Nieves
Granada, Granada, 18014
H. General Universitario Gregorio Marañón
Madrid, Madrid, 28007
H. Universitario Puerta de Hierro
Madrid, Madrid, 28222
H. Regional Universitario Carlos Haya
Málaga, Málaga, 29010
H. Universitario Virgen de la Arrixaca
Murcia, Murcia, 30120
H. Universitario Central de Asturias
Oviedo, Oviedo, 33006
Clínica Universitaria de Navarra
Pamplona, Navarre, 31008
H. Universitario de Canarias
San Cristóbal de La Laguna, Tenerife, 38320
H. Virgen Macarena
Seville, Sevilla, 41009
H. Infanta Elena
Valdemoro, Madrid, 28340
H. Universitario La Fé
Valencia, Valencia, 46009
About this study
Official title: Phase III, Multicenter, Randomized, Assessor-blind Study to Evaluate the Safety and Efficacy of CitraFleet (Sodium Picosulphate) as an Evacuating Treatment Prior to Colonoscopy.
The purpose of this study is to determine any significant differences in the efficacy and acceptability between CitraFleet and Klean Prep® (polyethylene glycol) for the preparation of gastrointestinal subjects undergoing a colon examination.
Read the detailed description
The composite principal objective of the current study will therefore be, to determine any significant differences in the joint variable of efficacy and acceptability between CitraFleet and Klean Prep® (polyethylene glycol) for the preparation of subjects undergoing a colon examination.
The evaluation will be carried out by two blinded assessors, independent of the investigator who performed the procedure (endoscopist investigator). It will be assessed from images of different sections of the colon: cecum, ascending, transverse, descending and rectum and subsequent confirmation by Principal Investigator if an agreement has been reached between the two blinded assessors or whether it is necessary to reach consensus.
The evaluation of the subject's acceptability will be assessed using a 5 point scale which assesses the difficulty of taking the product, the degree of discomfort caused by it, and the taste of the drug.
The secondary objective is to evaluate the safety of CitraFleet.
In addition a second exploratory arm of CitraFleet was included in this study (CitraFleet Exploratory arm). The study is not powered to make formal statistical comparisons for this arm. Exploratory assessment of this arm against the main CitraFleet regimen and Klean-Prep will be made in order to run future trials design with this schedule.
- Being tested
- Sodium picosulphate, light magnesium oxide and anhydride citric acid., Polyethylene glycol, KCl, NaCl, sodium sulphate anhydrous and sodium bicarbonate.
- Keywords
- Colonoscopy, Preparation, Evacuating, Bowel Cleansing.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium picosulphate, light magnesium oxide and anhydride citric acid.Drug
Also called Citrafleet
2 Single-dose sachets containing sodium picosulphate (0.01g/sachet), light magnesium oxide (3.50g/sachet) and anhydrous citric acid (10.97g/sachet).
Polyethylene glycol, KCl, NaCl, sodium sulphate anhydrous and sodium bicarbonate.Drug
Also called KleanPrep PEG 4l
4 sachets containing Polyethylene glycol 3350 (59 gr), KCl (0.7425 gr), NaCl (1.465 gr), sodium sulphate anhydrous (5.685 gr), sodium bicarbonate (1.685 gr).
| Study group | Role | What they receive |
|---|---|---|
| Citrafleet | Experimental | The day prior to the colonoscopy in two dose times, first at 15:00h and second at 20:00h. Receives: Drug: Sodium picosulphate, light magnesium oxide and anhydride citric acid. |
| Klean Prep | Active comparator | The day prior to the colonoscopy from 16:00h to 20:00h. Receives: Drug: Polyethylene glycol, KCl, NaCl, sodium sulphate anhydrous and sodium bicarbonate. |
| Citrafleet Exploratory | Experimental | The day of the colonoscopy in two dose times, first at 06:00h and second at 09:00h. Receives: Drug: Sodium picosulphate, light magnesium oxide and anhydride citric acid. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects that achieve 'excellent' or 'good' cleansing in the Fleet® Grading Scale for Bowel Cleansing.
Measured: 24 hours
Percentage of subjects who find the agent easy to take or tolerable using a 5 point scale which assesses, the difficulty of taking the product, the degree of discomfort caused by it, and the taste of the drug, recorded in the subject questionnaire
Measured: 24 hours
Secondary outcomes (1)
Frequency of adverse reactions.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionJun 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjects Undergoing a Complete Exploratory Diagnostic Colonoscopy for the First Time.Studies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 547 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratorios Casen-Fleet S.L.U.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Trial Form Support S.L., Apices Soluciones S.L.
- Investigators
- Miguel A. Muñoz-Navas, M.D., Principal investigator, Clínica Universitaria de Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01065857
- Sponsor's protocol ID
- CF-PICOS2006
- Status last verified
- Apr 2011
- First submitted
- 8 Feb 2010
- Last updated
- 15 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III, Multicenter, Randomized, Assessor-blind Study to Evaluate the Safety and Efficacy of CitraFleet (Sodium Picosulphate) as an Evacuating Treatment Prior to Colonoscopy.
- ClinicalTrials.gov ID
- NCT01065857
- Acronym / sponsor ID
- CF-PICOS2006
- Keywords
- Colonoscopy, Preparation, Evacuating, Bowel Cleansing.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 547 participants (estimated)
- Lead sponsor
- Laboratorios Casen-Fleet S.L.U.Industry (pharma, biotech, devices)
- Collaborators
- Trial Form Support S.L., Apices Soluciones S.L.
- Study start
- Jan 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 9 Feb 2010 (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 determine any significant differences in the efficacy and acceptability between CitraFleet and Klean Prep® (polyethylene glycol) for the preparation of gastrointestinal subjects undergoing a colon examination.
Detailed description
The composite principal objective of the current study will therefore be, to determine any significant differences in the joint variable of efficacy and acceptability between CitraFleet and Klean Prep® (polyethylene glycol) for the preparation of subjects undergoing a colon examination.
The evaluation will be carried out by two blinded assessors, independent of the investigator who performed the procedure (endoscopist investigator). It will be assessed from images of different sections of the colon: cecum, ascending, transverse, descending and rectum and subsequent confirmation by Principal Investigator if an agreement has been reached between the two blinded assessors or whether it is necessary to reach consensus.
The evaluation of the subject's acceptability will be assessed using a 5 point scale which assesses the difficulty of taking the product, the degree of discomfort caused by it, and the taste of the drug.
The secondary objective is to evaluate the safety of CitraFleet.
In addition a second exploratory arm of CitraFleet was included in this study (CitraFleet Exploratory arm). The study is not powered to make formal statistical comparisons for this arm. Exploratory assessment of this arm against the main CitraFleet regimen and Klean-Prep will be made in order to run future trials design with this schedule.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Citrafleet | Experimental | Drug: Sodium picosulphate, light magnesium oxide and anhydride citric acid.The day prior to the colonoscopy in two dose times, first at 15:00h and second at 20:00h. |
| Klean Prep | Active comparator | Drug: Polyethylene glycol, KCl, NaCl, sodium sulphate anhydrous and sodium bicarbonate.The day prior to the colonoscopy from 16:00h to 20:00h. |
| Citrafleet Exploratory | Experimental | Drug: Sodium picosulphate, light magnesium oxide and anhydride citric acid.The day of the colonoscopy in two dose times, first at 06:00h and second at 09:00h. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects who are between 18 and 80 years of age.
- Subjects undergoing complete colonoscopy and therefore require prior preparation with either Klean Prep® or CitraFleet.
- Subjects capable of maintaining appropriate oral hydration during the intestinal preparation process.
- Subjects that have provided written informed consent.
- Subjects in whom the use of any of the study drugs (KleanPrep®,CitraFleet) is not contraindicated.
Key exclusion criteria (16 listed)
- Severe renal insufficiency.
- Ascites.
- Congestive heart failure.
- Gastrointestinal obstruction, gastric retention, intestinal perforation and/or ileus.
- Megacolon and/or toxic colitis.
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 picosulphate, light magnesium oxide and anhydride citric acid.Also: Citrafleet2 Single-dose sachets containing sodium picosulphate (0.01g/sachet), light magnesium oxide (3.50g/sachet) and anhydrous citric acid (10.97g/sachet). | Drug | Citrafleet, Citrafleet Exploratory |
| Polyethylene glycol, KCl, NaCl, sodium sulphate anhydrous and sodium bicarbonate.Also: KleanPrep PEG 4l4 sachets containing Polyethylene glycol 3350 (59 gr), KCl (0.7425 gr), NaCl (1.465 gr), sodium sulphate anhydrous (5.685 gr), sodium bicarbonate (1.685 gr). | Drug | Klean Prep |
Primary outcome
Percentage of subjects that achieve 'excellent' or 'good' cleansing in the Fleet® Grading Scale for Bowel Cleansing.
Time frame: 24 hours
Percentage of subjects who find the agent easy to take or tolerable using a 5 point scale which assesses, the difficulty of taking the product, the degree of discomfort caused by it, and the taste of the drug, recorded in the subject questionnaire
Time frame: 24 hours
1 secondary outcome
Frequency of adverse reactions.
Time frame: 24 hours
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 15 Apr 2011.
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.
Miguel A. Muñoz-Navas, M.D. principal investigator
Clínica Universitaria de Navarra
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sodium picosulphate, light magnesium oxide and anhydride citric acid. and Polyethylene glycol, KCl, NaCl, sodium sulphate anhydrous and sodium bicarbonate. in people with Subjects Undergoing a Complete Exploratory Diagnostic Colonoscopy for the First Time., run by Laboratorios Casen-Fleet S.L.U. at 15 sites in Spain.
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 7 inclusion and 16 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 15 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Spain. 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?
Percentage of subjects that achieve 'excellent' or 'good' cleansing in the Fleet® Grading Scale for Bowel Cleansing. (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Apr 2011.