A Study Comparing the Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution With PREPOPIK® for Colon Cleansing in Preparation for Colonoscopy

Ferring

Status and phase: Completed; Phase 3

Conditions: Bowel Preparation

Treatments: Drug: Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution; Drug: Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder

Study type: Interventional

Funder types: Industry

Identifiers

NCT03017235

000253

Details and patient eligibility

About

The purpose of this study is to compare the Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution with PREPOPIK® for colon cleansing in adult subjects undergoing colonoscopy.

Enrollment: 917 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or non-pregnant female subjects aged 18 to 80 years, inclusive, being scheduled to undergo elective colonoscopy
• Females of childbearing potential must agree to use an adequate contraception during the course of the trial. Accepted forms of contraception are: i.e., implants, injectables, hormonal intrauterine device, combined hormonal contraceptives, sexual abstinence, and vasectomized sexual partner. Premenopausal women who are of childbearing potential must have a negative serum pregnancy test result at screening and a negative urine pregnancy test result at randomization prior to colonoscopy. In the case of oral contraceptive use, women should have been taking the same pill consistently for a minimum of twelve (12) weeks before taking study medication. Sterilized or postmenopausal women may also participate. Women are considered to be postmenopausal and are not considered to be of childbearing potential if they have had twelve (12) months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation.
• An average of at least 3 spontaneous bowel movements per week for one month prior to the colonoscopy

Exclusion criteria

• Known or suspected gastrointestinal obstruction, perforation, ileus, or gastric retention
• Acute intestinal or gastric ulceration
• Severe acute inflammatory bowel disease (IBD), toxic colitis, or toxic megacolon
• Undergoing colonoscopy for foreign body removal or decompression
• Reduced level of consciousness or inability to swallow without aspiration
• Any prior colorectal surgery, excluding appendectomy, hemorrhoid surgery, or prior endoscopic procedures
• Upper gastrointestinal surgery (gastrectomy, gastric banding, gastric by-pass)
• Uncontrolled angina and/or myocardial infarction (MI) within last three months, congestive heart failure (CHF), uncontrolled hypertension, or ascites
• Severely reduced renal function (<30 mL/min/1.73 m2)
• Pregnant or lactating women
• Any clinically relevant abnormal findings in medical history, physical examination, vital signs, ECG, clinical chemistry, hematology, coagulation, or urinalysis at Screening Visit 1
• Rhabdomyolysis
• Chronic nausea and vomiting
• Hypermagnesemia
• Undergoing treatment with Lithium

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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917 participants in 2 patient groups

NaP/MC Oral Solution

Experimental group

Description:

Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution

Treatment:

Drug: Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution

PREPOPIK®

Active Comparator group

Treatment:

Drug: Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder