Ulcerative ColitisPhase 4NCT03581149
Tolerability and Efficacy of Sodium Picosulfate/Magnesium Citrate Versus PEG/Ascorbic Acid in Ulcerative Colitis Patients
A Phase 4 study testing Sodium Picosulfate/Magnesium Citrate Laxative and 2L polyethylene glycol/ascorbic acid in people with Ulcerative Colitis, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
Ulcerative colitis is a chronic condition that results in the inflammation of the colon and rectum. Patients suspected to have ulcerative colitis are diagnosed via colonoscopy. Moreover, colonoscopy is considered to be the preferred procedure for assessing the activity and extent of the disease, as well as monitoring… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Sodium Picosulfate/Magnesium Citrate Laxative and 2L polyethylene glycol/ascorbic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteLebanon
- Study dates
- 26 Mar 2018to 26 Jul 2020
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with Ulcerative Colitis
- Patients undergoing elective outpatient colonoscopy
- Patients consenting to the study
Who cannot join
- Age less than 18 years
- Pregnant or lactating women
- Significant gastroparesis
- Gastric outlet obstruction
- Ileus
- Known or suspected bowel obstruction or perforation
Show all 20Show fewer
- Phenylketonuria
- Toxic colitis or megacolon
- Having a stoma
- Compromised swallowing reflex or mental status
- Psychiatric disease or known or suspected poor compliance
- Severe chronic renal failure (creatinine clearance <30 mL/minute)
- Severe congestive heart failure (New York Heart Association [NYHA] class III or IV)
- Dehydration
- Laxative use or dependency
- Chronic constipation (<3 spontaneous bm/week)
- Uncontrolled hypertension (systolic blood pressure ≥170 mm Hg, diastolic blood pressure ≥100 mm Hg)
- Prior colon resection
- Age above 65 years
- Profusely bleeding patients with severe UC
Trial locations and contacts
1 site in 1 country.
Lebanon1 site, 1 recruiting
- Recruiting
American University of Beirut
Beirut
Louma Rustam, MD
Ala Sharara, MD
About this study
Official title: Tolerability and Efficacy of Low-Volume Sodium Picosulfate/Magnesium Citrate Versus 2L Polyethylene Glycol/Ascorbic Acid in Patients With Ulcerative Colitis Undergoing Colonoscopy: A Randomized Controlled Trial
Ulcerative colitis is a chronic condition that results in the inflammation of the colon and rectum. Patients suspected to have ulcerative colitis are diagnosed via colonoscopy. Moreover, colonoscopy is considered to be the preferred procedure for assessing the activity and extent of the disease, as well as monitoring treatment response and development of lesions. Therefore, optimal performance and visualization of mucosal lesions via adequate bowel preparation is essential in such patients. In addition, the nature of the disease and the need for multiple colonoscopies throughout a patient's lifetime makes compliance to repeated procedures difficult.
It is well known that colonoscopy preparations are generally poorly tolerated, disliked and, consequently serve as an additional burden on patients.Polyethylene glycol (PEG), despite being the golden standard, is not very well tolerated. Inadequate bowel preparations are associated with cancelled procedures, prolonged procedure time, incomplete examination, increased cost and possibly complications, physician frustration and patient anxiety, but most importantly, with missed pathology. A good bowel preparation would need a solution with reasonable volume, acceptable taste, minimal diet restrictions, and easy-to-follow instructions. The strict need for adherence to drinking a relatively large volume of solution preparation may result in poor compliance.
Read more
Despite the emergence of several types of low volume preparations, the evidence on the use of such solutions remains sparse. This is especially true in terms of patients' tolerability to the solution, and its relation with adequate bowel preparation during colonoscopy.
The investigator's aim is to assess how small volume preparations such as sodium picosulfate/magnesium citrate (Citrafleet®) enhance participants tolerability to the solution, compliance, and adequacy of bowel preparations when compared to 2L polyethylene glycol + ascorbic acid (MoviPrep®) in patients with Ulcerative Colitis.
- Conditions
- Ulcerative Colitis
- Being tested
- Sodium Picosulfate/Magnesium Citrate Laxative, 2L polyethylene glycol/ascorbic acid
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Picosulfate/Magnesium Citrate LaxativeDrug
Also called (Citrafleet®)
● First arm: Patients will receive sodium picosulfate/magnesium citrate (Citrafleet®) solution with an instruction leaflet.
2L polyethylene glycol/ascorbic acidDrug
Also called (MoviPrep®)
- First arm: Patients will receive sodium picosulfate/magnesium citrate (Citrafleet®) solution with an instruction leaflet.
- Second arm: Patients will receive 2L polyethylene glycol + ascorbic acid (MoviPrep®) solution with an instruction leaflet.
| Study group | Role | What they receive |
|---|---|---|
| Citrafleet® | Active comparator | Patients will receive sodium picosulfate/magnesium citrate (Citrafleet®) solution with an instruction leaflet. Receives: Drug: Sodium Picosulfate/Magnesium Citrate Laxative |
| MoviPrep® | Active comparator | Patients will receive 2L polyethylene glycol + ascorbic acid (MoviPrep®) solution with an instruction leaflet. Receives: Drug: 2L polyethylene glycol/ascorbic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability of the preparation as assessed by a Likert-type scale
Patients will answer a data collection sheet with questions regarding their ability to tolerate the preparation without difficulty. We are using a Likert-type scale from 1 to 5, 1 being completely intolerable and 5 being very easily tolerated.
Measured: 1 year
Secondary outcomes (3)
Quality of the preparation as assessed by the Modified Aronchick scale.
A data collection sheet will be handed to the blinded endoscopist to answer questions related to the quality of the preparation. A description ranging from Poor to Excellent is assigned to the quality of the prepped colon.
Poor - Re-preparation required; large amount of fecal residue precludes a complete examination
Inadequate - Inadequate but examination completed; enough feces or turbid fluid to prevent a reliable examination; less than 90%mucosa seen
Fair - Moderate amount of stool that can be cleared with suctioning permitting adequate evaluation of entire colonic mucosa; more than 90% mucosa seen
Good - Small amount of turbid fluid without feces not interfering with examination; more than 90% mucosa seen
Excellent - Small amount of clear liquid with clear mucosa seen; more than 95% mucosa seen
Measured: 1 year
Quality of the preparation as assessed by the Boston Bowel Preparation Scale.
A data collection sheet will be handed to the blinded endoscopist to answer questions related to the quality of the preparation. A score ranging from 0 to 3 is assigned to each of the three segments of the colon: Right colon, Mid colon and Left colon. The scores are calculated as follows:
0 = Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared.
- = Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool and/or opaque liquid.
- = Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well.
- = Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid.
Measured: 1 year
Assessment of adherence to protocol
Patients will answer a set of questions in a data collection sheet pertaining to
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start26 Mar 2018
- Primary completion26 Jul 2020 (estimated)
- Study completion26 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ala'a Sharara, MD, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03581149
- Sponsor's protocol ID
- BIO-2017-0434
- Status last verified
- Sep 2019
- First submitted
- 27 Mar 2018
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerability and Efficacy of Low-Volume Sodium Picosulfate/Magnesium Citrate Versus 2L Polyethylene Glycol/Ascorbic Acid in Patients With Ulcerative Colitis Undergoing Colonoscopy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03581149
- Acronym / sponsor ID
- BIO-2017-0434
- Conditions
- Ulcerative Colitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- 26 Mar 2018 (actual)
- Primary completion
- 26 Jul 2020 (estimated)
- Study completion
- 26 Jul 2020 (estimated)
- First posted
- 10 Jul 2018 (actual)
- 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.
Ulcerative colitis is a chronic condition that results in the inflammation of the colon and rectum. Patients suspected to have ulcerative colitis are diagnosed via colonoscopy. Moreover, colonoscopy is considered to be the preferred procedure for assessing the activity and extent of the disease, as well as monitoring treatment response and development of lesions. Therefore, optimal performance and visualization of mucosal lesions via adequate bowel preparation is essential in such patients. In addition, the nature of the disease and the need for multiple colonoscopies throughout a patient's lifetime makes compliance to repeated procedures difficult.
It is well known that colonoscopy preparations are generally poorly tolerated, disliked and, consequently serve as an additional burden on patients.Polyethylene glycol (PEG), despite being the golden standard, is not very well tolerated. Inadequate bowel preparations are associated with cancelled procedures, prolonged procedure time, incomplete examination, increased cost and possibly complications, physician frustration and patient anxiety, but most importantly, with missed pathology. A good bowel preparation would need a solution with reasonable volume, acceptable taste, minimal diet restrictions, and easy-to-follow instructions. The strict need for adherence to drinking a relatively large volume of solution preparation may result in poor compliance.
Despite the emergence of several types of low volume preparations, the evidence on the use of such solutions remains sparse. This is especially true in terms of patients' tolerability to the solution, and its relation with adequate bowel preparation during colonoscopy.
The investigator's aim is to assess how small volume preparations such as sodium picosulfate/magnesium citrate (Citrafleet®) enhance participants tolerability to the solution, compliance, and adequacy of bowel preparations when compared to 2L polyethylene glycol + ascorbic acid (MoviPrep®) in patients with Ulcerative Colitis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Citrafleet® | Active comparator | Drug: Sodium Picosulfate/Magnesium Citrate LaxativePatients will receive sodium picosulfate/magnesium citrate (Citrafleet®) solution with an instruction leaflet. |
| MoviPrep® | Active comparator | Drug: 2L polyethylene glycol/ascorbic acidPatients will receive 2L polyethylene glycol + ascorbic acid (MoviPrep®) solution with an instruction leaflet. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with Ulcerative Colitis
- Patients undergoing elective outpatient colonoscopy
- Patients consenting to the study
Key exclusion criteria (20 listed)
- Age less than 18 years
- Pregnant or lactating women
- Significant gastroparesis
- Gastric outlet obstruction
- Ileus
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 Picosulfate/Magnesium Citrate LaxativeAlso: (Citrafleet®)● First arm: Patients will receive sodium picosulfate/magnesium citrate (Citrafleet®) solution with an instruction leaflet. | Drug | Citrafleet® |
| 2L polyethylene glycol/ascorbic acidAlso: (MoviPrep®)* First arm: Patients will receive sodium picosulfate/magnesium citrate (Citrafleet®) solution with an instruction leaflet. * Second arm: Patients will receive 2L polyethylene glycol + ascorbic acid (MoviPrep®) solution with an instruction leaflet. | Drug | MoviPrep® |
Primary outcome
Tolerability of the preparation as assessed by a Likert-type scale
Time frame: 1 year
Patients will answer a data collection sheet with questions regarding their ability to tolerate the preparation without difficulty. We are using a Likert-type scale from 1 to 5, 1 being completely intolerable and 5 being very easily tolerated.
3 secondary outcomes
Quality of the preparation as assessed by the Modified Aronchick scale.
Time frame: 1 year
Quality of the preparation as assessed by the Boston Bowel Preparation Scale.
Time frame: 1 year
Assessment of adherence to protocol
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sodium Picosulfate/Magnesium Citrate Laxative and 2L polyethylene glycol/ascorbic acid in people with Ulcerative Colitis, run by American University of Beirut Medical Center at 1 site in Lebanon.
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 20 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: status not confirmed, as of the sponsor's last update on 19 Sep 2019. 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 Lebanon. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ala Sharara, M.D (00961893989, as08@aub.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability of the preparation as assessed by a Likert-type scale (time frame: 1 year). 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 19 Sep 2019.