Phase 3
Completed N=204
A Trial Comparing the PICOPREP Tailored Dosing Schedule to the PICOPREP Day-before Dosing Schedule for Colon Cleansing in Preparation for Colonoscopy
Bowel Cleansing
Source: ClinicalTrials.gov NCT02239692 ↗
Enrolled (actual)
204
Serious AEs
0.5%
Results posted
Jun 2016
Primary outcomePrimary: Overall Colon Cleansing Procedure (ITT) Measured by the Total Ottawa Scale — 8.2; 4.2 score on a scale — p=<0.0001
◆ Published Evidence
Emerging
9citations · ~1 / year
Efficacy and safety of PICOPREP tailored dosing compared with PICOPREP day-before dosing for colon cleansing: a multi-centric randomised study.
Summary
This was a phase 3, randomised, assessor-blinded, multi-centre trial comparing the efficacy, safety and tolerability of a PICOPREP tailored dosing schedule to the PICOPREP day-before dosing schedule for colon cleansing in preparation for colonoscopy.
Linked Publications
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Efficacy and safety of PICOPREP tailored dosing compared with PICOPREP day-before dosing for colon cleansing: a multi-centric randomised study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Colon Cleansing Procedure (ITT) Measured by the Total Ottawa Scale |
8.2; 4.2 | <0.0001 sig |
| PRIMARY Overall Colon Cleansing Procedure (PP) Measured by the Total Ottawa Scale |
8.1; 3.7 | <0.0001 sig |
| SECONDARY Ascending Colon Cleansing Responder Status (ITT) |
15.1; 61.1 | <0.0001 sig |
| SECONDARY Frequency and Intensity of Adverse Events |
4; 15; 4; 12; 0; 2 | — |
| SECONDARY Clinically Significant Changes in Vital Signs (Pulse and Blood Pressure) |
0; 0; 0; 0 | — |
| SECONDARY Clinically Significant Changes in Laboratory Values (Haematology, Clinical Chemistry, Coagulation and Urinalysis) |
0; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female, 18 years of age or above, being scheduled to undergo elective colonoscopy
- Subjects must have had more than or equal to 3 spontaneous bowel movements (i.e. without use of any laxative within 24 hours before the bowel movement, with the exception for bulk-forming laxatives (ATC code A06AC)) per week for one month prior to the colonoscopy
Exclusion Criteria
- Acute surgical abdominal conditions (e.g. acute obstruction or perforation, etc.)
- Active (acute/exacerbation of/severe/uncontrolled) Inflammatory Bowel Disease (IBD)
- Any prior colorectal surgery, excluding appendectomy, haemorrhoid surgery or prior endoscopic procedures
- Colon disease (history of colonic cancer, toxic megacolon, toxic colitis, idiopathic pseudoobstruction, hypomotility syndrome)
- Ascites
- Gastrointestinal disorder (active ulcer, outlet obstruction, retention, gastroparesis, ileus)
- Upper gastrointestinal surgery (gastric resection, gastric banding, gastric by-pass)
- Severely reduced renal function (Glomerular filtration rate (GFR) <30 (mL/min/1.73 m2))
- The subject is a pregnant (positive urine pregnancy test at Visit 1 or Visit 2) woman. Women of childbearing potential (defined, for the purpose of this trial, as all females post-puberty, not postmenopausal ≥2 years, or not surgically sterile) who do not agree to use one of the following methods of birth control from the day of signing the Informed Consent Form until End of Trial Visit are excluded:
- Transdermal patch
- Hormonal contraception (i.e., oral, implant, or injectable contraceptive)
- Double-barrier birth control (i.e., condom plus intrauterine device, diaphragm plus spermicide, etc.)
- Maintenance of a monogamous relationship with a male who has been surgically sterilised by vasectomy
- Sexual abstinence
- The subject is a breast-feeding or lactating woman
Data sourced from ClinicalTrials.gov (NCT02239692) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.