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Prucalopride + Prucalopride Booster vs. Prucalopride + Picosalax Booster for the Colon Capsule

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01864915
Recruitment Status : Completed
First Posted : May 30, 2013
Last Update Posted : February 16, 2017
Sponsor:
Collaborators:
Hotel Dieu Hospital
Janssen Inc.
Information provided by (Responsible Party):
Dr. Lawrence Hookey, Queen's University

Brief Summary:

Colon capsule endoscopy is a new technology that is a noninvasive method of examining the large bowel. The bowel preparation required for this test differs from colonoscopy in that it needs to clean the colon but also needs to provide propulsion. Most published studies have used medications as part of their regime that are not available in parts of North America (ex. sodium phosphate) and have shown poor test completion, bowel preparation and polyp detection rates.

Objective: In this study a bowel preparation for the colon capsule is proposed that uses medications approved for use in Canada that may provide a better preparation quality and better completion rates.

Methods: Patients who are being referred for a colonoscopy will be recruited to participate in the study. They will all receive split-dose polyethylene glycol (PEG) for bowel preparation. They will be randomized to receive either 1) Prucalopride 2mg daily for four days, 2) Prucalopride 2mg daily for four days plus a Prucalopride booster, or 3) Prucalopride 2mg for four days plus 1 and 1/2 sachets of Picosalax boosters for the colon capsule study. The day after the colon capsule they will drink PEG ( 2 Liters) at 5am -or approx 4hrs prior to procedure time and return for a colonoscopy. The colon capsule results will be reviewed by two endoscopists experienced in video capsule endoscopy who will assess the bowel preparation using a previously defined scale and examine for polyps. We propose that administering Prucalopride daily for 4 days will increase intestinal motility and improve colon capsule completion rates and a booster dose of Picosalax will improve colon capsule completion rates compared to prucalopride by itself.


Condition or disease Intervention/treatment Phase
Bowel Cleansing Colon Capsule Completion Times Drug: Prucalopride Procedure: Colon Capsule Phase 3

Detailed Description:

Colon capsule endoscopy is a new technology that is a noninvasive method of examining the large bowel. The bowel preparation required for this test differs from colonoscopy in that it needs to clean the colon but also needs to provide propulsion. Most published studies have used medications as part of their regime that are not available in parts of North America (ex. sodium phosphate) and have shown poor test completion, bowel preparation and polyp detection rates.

Objective: In this study a bowel preparation for the colon capsule is proposed that uses medications approved for use in Canada that may provide a better preparation quality and better completion rates.

Methods: Patients who are being referred for a colonoscopy will be recruited to participate in the study. They will all receive split-dose polyethylene glycol (PEG) for bowel preparation. They will be randomized to receive either 1) Prucalopride 2mg daily for four days, 2) Prucalopride 2mg daily for four days plus a Prucalopride booster, or 3) Prucalopride 2mg for four days plus 1 and 1/2 sachets of Picosalax boosters for the colon capsule study. The day after the colon capsule they will drink PEG ( 2 Liters) at 5am -or approx 4hrs prior to procedure time and return for a colonoscopy. The colon capsule results will be reviewed by two endoscopists experienced in video capsule endoscopy who will assess the bowel preparation using a previously defined scale and examine for polyps. We propose that administering Prucalopride daily for 4 days will increase intestinal motility and improve colon capsule completion rates and a booster dose of Picosalax will improve colon capsule completion rates compared to prucalopride by itself

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Prucalopride + Prucalopride Booster vs. Prucalopride + Picosalax Booster for the Colon Capsule
Study Start Date : June 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Arm Intervention/treatment
Experimental: No Booster-low dose prucalopride booster
low dose prucalopride booster arm
Drug: Prucalopride
Prucalopride 2mg daily starting three days before the colon capsule study (total of 4 doses with the last at 0800hrs on day of colon capsule study)
Other Name: RESTORAN

Procedure: Colon Capsule
Colon capsule procedure performed day prior to colonoscopy, at 0800 hrs on day 4.

Experimental: Prucalopride Booster-high dose prucalopride booster
additional 2mg prucalopride at time of capsule ingestion
Drug: Prucalopride
Prucalopride 2mg daily starting three days before the colon capsule study (total of 4 doses with the last at 0800hrs on day of colon capsule study)
Other Name: RESTORAN

Procedure: Colon Capsule
Colon capsule procedure performed day prior to colonoscopy, at 0800 hrs on day 4.

Experimental: Picosalax Booster Arm
One sachet of Picosalax 2hrs after capsule ingestion and 1/2 sachet at 4 hrs after swallowing colon capsule.
Drug: Prucalopride
Prucalopride 2mg daily starting three days before the colon capsule study (total of 4 doses with the last at 0800hrs on day of colon capsule study)
Other Name: RESTORAN

Procedure: Colon Capsule
Colon capsule procedure performed day prior to colonoscopy, at 0800 hrs on day 4.




Primary Outcome Measures :
  1. To assess the quality of the bowel preparations [ Time Frame: Day of colon capsule procedure and day of colonoscopy ]

    Colon capsule bowel prep assessed with previously used scale completed by designated gastroenterologists.

    Colonoscopy bowel prep assessed by completion of Aronchick Scale by endoscopist performing procedure.



Secondary Outcome Measures :
  1. Tolerance of Bowel Preparation with survey [ Time Frame: Day of colonoscopy ]
  2. Gastric, small bowel and colon transit time [ Time Frame: Day of colon capsule ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients between the ages of 18-75 being referred for colonoscopy

Exclusion Criteria:

  • symptoms of dysphagia or any problems with swallowing, bowel obstruction or ileus, known stricture or fistula, inflammatory bowel disease, previous small or large bowel surgery, severe gastroparesis or motility disorder, severe renal impairment ( defined as lab test result eGFR ie. estimated Glomerular Filtration Rate less than 55 within three months of study), congestive heart failure (NYHA III or IV), ischemic heart disease (acute event in the last 6mths), decompensated cirrhosis or severe hepatic dysfunction (ascites or known lab test INR>2), history of serious arrhythmia or any other severe and clinically unstable concomitant disease (eg. lung disease, neurological or psychiatric disorder, cancer, AIDS and other endocrine disorder) ,diabetics on treatment with insulin or hypoglycemic, pregnant or nursing women, galactose intolerance (since the tablets contain lactose monohydrate, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose/galactose malabsorption must not take this medicinal product.) or known hypersensitivity to the drug or to any ingredient in the formulation (each 2mg tablet contains prucalopride 2 mg. Nonmedicinal ingredients: tablet core: lactose monohydrate, microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate; coating: hypromellose, lactose monohydrate, triacetin, titanium dioxide, macrogol 3000, iron oxide red, iron oxide yellow, and FD&C Blue No. 2 Aluminum Lake) Females of child bearing potential who are unwilling to use appropriate birth control methods during the study will not be able to participate in this clinical trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01864915


Locations
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Canada, Ontario
Hotel Dieu Hospital
Kingston, Ontario, Canada, K7L 5V7
Sponsors and Collaborators
Queen's University
Hotel Dieu Hospital
Janssen Inc.
Investigators
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Principal Investigator: Lawrence Hookey Queen's University

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Responsible Party: Dr. Lawrence Hookey, Principal Investigator, Queen's University
ClinicalTrials.gov Identifier: NCT01864915    
Other Study ID Numbers: DMED 1578-13 HOOKEY
9427-D2773-21C ( Other Identifier: Health Canada TPD )
First Posted: May 30, 2013    Key Record Dates
Last Update Posted: February 16, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: final analysis dataset shared with Janssen Inc (study sponsor)
Keywords provided by Dr. Lawrence Hookey, Queen's University:
colon capsule
bowel preparation
booster
prucalopride
picosalax
Additional relevant MeSH terms:
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Prucalopride
Laxatives
Gastrointestinal Agents
Serotonin 5-HT4 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs