Tolerability and Efficacy of Sodium Picosulfate/Magnesium Citrate Versus PEG/Ascorbic Acid in Ulcerative Colitis Patients

NCT03581149 | Unknown Phase 4 DMC

• 1 other identifier: BIO-2017-0434
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (3)

• Quality of the preparation as assessed by the Modified Aronchick scale.

  1 year

• Quality of the preparation as assessed by the Boston Bowel Preparation Scale.

  1 year

• Assessment of adherence to protocol

  1 year

Study Arms (2)

Citrafleet®

ACTIVE COMPARATOR

Patients will receive sodium picosulfate/magnesium citrate (Citrafleet®) solution with an instruction leaflet.

Drug: Sodium Picosulfate/Magnesium Citrate Laxative

MoviPrep®

ACTIVE COMPARATOR

Patients will receive 2L polyethylene glycol + ascorbic acid (MoviPrep®) solution with an instruction leaflet.

Drug: 2L polyethylene glycol/ascorbic acid

Interventions

Sodium Picosulfate/Magnesium Citrate Laxative DRUG

● First arm: Patients will receive sodium picosulfate/magnesium citrate (Citrafleet®) solution with an instruction leaflet.

Also known as: (Citrafleet®)

Citrafleet®

2L polyethylene glycol/ascorbic acid DRUG

* 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.

Also known as: (MoviPrep®)

MoviPrep®

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with Ulcerative Colitis
• Patients undergoing elective outpatient colonoscopy
• Patients consenting to the study

You may not qualify if:

• Age less than 18 years
• Pregnant or lactating women
• Significant gastroparesis
• Gastric outlet obstruction
• Ileus
• Known or suspected bowel obstruction or perforation
• 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

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

American University of Beirut

Beirut, Lebanon

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

picosulfate sodium; Polyethylene Glycols; Ascorbic Acid; MoviPrep

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Carbohydrates

Central Study Contacts

Ala Sharara, M.D

CONTACT

00961893989; as08@aub.edu.lb

Louma Rustam, M.D

CONTACT

00961952395; lr22@aub.edu.lb

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 27, 2018
• First Posted: July 10, 2018
• Study Start: March 26, 2018
• Primary Completion: July 26, 2020
• Study Completion: July 26, 2020
• Last Updated: September 19, 2019

Record last verified: 2019-09

Locations

LE (1)