Investigation of PICOPREP and PEG-ELS for Bowel Preparation for Colonoscopy

NCT01356407 | Completed Phase 3 Results

• 1 other identifier: FE999169 CS02
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 7

Brief Summary

Eligible subjects undergoing a colonoscopy will randomly receive either PICOPREP or polyethylene glycol 4000 electrolyte lavage solution before the procedure to evaluate its effectiveness, tolerability and safety.

Conditions

Colonoscopy

Outcome Measures

Primary Outcomes (1)

• The Ottawa Scale Score of Patients Who Had Successfully Completed the Colonoscopy Examination After Having Completed the Study Bowel Preparation

  The total Ottawa Bowel Preparation Scale (OBPS) score, rated by the treatment-blinded Investigator at colonoscopy, was designed to evaluate cleanliness of the colon by grading the endoscopic visibility of the mucosa according to a scale from 0 ('excellent' visibility) to 4 ('inadequate' visibility); The component scores for each of the colon segment are added together, along with an overall 'fluid' score (from small amount = 0, to large amount = 2). Thus, the total OBPS has a range from 0 (a perfect preparation) to 14 (a completely unprepared bowel)

  day 2

Secondary Outcomes (5)

• Patient Response to Acceptability and Tolerability Questionnaire

  Day 2

• Ottawa Scale Score by Colon Segment

  Day 2

• Percentage of Successful Completion of Colonoscopy

  Day 2

• Proportion of Successful Colonoscopies in the Clinical Setting (Predicted by Ottawa Scale Score)

  Day 2

• Proportion of Subjects Requiring a Repeat Colonoscopy Due to Poor Bowel Preparation

  Day 2

Study Arms (2)

PICOPREP

EXPERIMENTAL

"Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy.

Drug: PICOPREP

PEG-ELS

ACTIVE COMPARATOR

PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.

Drug: PEG-ELS

Interventions

PICOPREP DRUG

PICOPREP

PEG-ELS DRUG

PEG-ELS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have signed the informed consent form and have been verbally explained the details of the trial and treatment procedures
• Chinese citizen
• Males or females aged between 18 and 70 years inclusive
• Patients scheduled for colonoscopy
• Patients who are able to observe instructions given during the study, and are able to complete the entire study procedure

You may not qualify if:

• Those pregnant, breastfeeding, or with the intention of becoming pregnant, or fertile women who are not on effective birth control
• Taking concomitant lithium
• Allergy to any ingredient in the study medication
• History of gastrointestinal diseases (active ulcers, gastric outlet obstruction, gastric retention, intestinal obstruction)
• Colon diseases (toxic megacolon, toxic colitis, idiopathic intestinal pseudo-obstruction, gastric retention, intestinal obstruction, lazy bowel syndrome) at screening
• Active (acute/severe/uncontrolled) Inflammatory Bowel Disease (IBD)
• Acute abdominal symptoms (acute intestinal obstruction, intestinal perforation, diverticulitis or appendicitis)
• Ascites
• History of surgery in upper gastrointestinal tract (gastrectomy, gastric banding, gastric bypass surgery)
• History of colorectal surgery (excluding appendectomy, hemorrhoidectomy and endoscopic surgery)
• Uncontrolled angina and/or myocardial infarction, congestive heart failure, or uncontrolled hypertension within 3 months prior randomisation
• Severe liver damage
• Kidney function impairment
• Diabetics currently on insulin treatment
• Having participated in any other clinical trial during the 3 month prior recruitment

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (7)

Nanfang Hospital, Southern Medical University

Guangzhou, China

Location

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, China

Location

Drum Tower Hospital

Nanjing, China

Location

Changhai Hospital, The Second Military Medical University

Shanghai, China

Location

Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, China

Location

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, China

Location

Huazhong Technological University Tongji Medical College Affiliated Union Hospital

Wuhan, China

Location

MeSH Terms

Interventions

picosulfate sodium

Results Point of Contact

• Title: Clinical Development Support
• Organization: Ferring Pharmaceuticals

DK0-Disclosure@ferring.com

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2011
• First Posted: May 19, 2011
• Study Start: January 1, 2011
• Primary Completion: May 1, 2011
• Study Completion: July 1, 2011
• Last Updated: January 28, 2013
• Results First Posted: January 28, 2013

Record last verified: 2012-12

Locations

CN (7)