A Trial Comparing the PICOPREP Tailored Dosing Schedule to the PICOPREP Day-before Dosing Schedule for Colon Cleansing in Preparation for Colonoscopy (OPTIMA)

Ferring

Status and phase: Completed; Phase 3

Conditions: Bowel Cleansing

Treatments: Drug: PICOPREP

Study type: Interventional

Funder types: Industry

Identifiers

NCT02239692

2014-001062-10 (EudraCT Number)

000121

Details and patient eligibility

About

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.

Enrollment: 204 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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:

  1. Transdermal patch
  2. Hormonal contraception (i.e., oral, implant, or injectable contraceptive)
  3. Double-barrier birth control (i.e., condom plus intrauterine device, diaphragm plus spermicide, etc.)
  4. Maintenance of a monogamous relationship with a male who has been surgically sterilised by vasectomy
  5. Sexual abstinence

• The subject is a breast-feeding or lactating woman

Trial design

204 participants in 2 patient groups

PICOPREP day-before dosing schedule

Active Comparator group

Description:

Both doses administered the day before colonoscopy.

Treatment:

Drug: PICOPREP

PICOPREP tailored dosing schedule

Experimental group

Description:

First dose one day before colonoscopy or on the day of colonoscopy, dependent on the planned time for colonoscopy, and second dose on the day of colonoscopy.

Treatment:

Drug: PICOPREP