Clinical trial NCT03017235: A Study Comparing the Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution With PREPOPIK® for Colon Cleansing in Preparation for Colonoscopy
Official title: A Randomized, Assessor-Blinded, Multi-Center Study Investigating the Efficacy, Safety, and Tolerability of Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution Versus Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Powder for Oral Solution (PREPOPIK®) for Colon Cleansing in Preparation for Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bowel Preparation
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2017-01-11
Enrollment: 917
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Subjects Classified as a Responder Defined by "Excellent" or "Good"
timeFrame: During colonoscopy procedure (5-9 hours after completed treatment)
Secondary outcomes:
measure: Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Right Segment of the Colon
timeFrame: During colonoscopy procedure (5-9 hours after completed treatment)
measure: Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Transverse Segment of the Colon
timeFrame: During colonoscopy procedure (5-9 hours after completed treatment)
measure: Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Left Segment of the Colon
timeFrame: During colonoscopy procedure (5-9 hours after completed treatment)
measure: Frequency of Each Category on the Subject Tolerability Questionnaire (How Many Bowel Movements Did You Have in the Week Prior to Starting Colon Preparation?)
timeFrame: During colonoscopy procedure (5-9 hours after completed treatment)
measure: Frequency of Each Category on the Subject Tolerability Questionnaire (How Much Bowel Preparation Was Left in Bottle After Drinking it?)
timeFrame: During colonoscopy procedure (5-9 hours after completed treatment)
measure: Frequency of Each Category on the Subject Tolerability Questionnaire (Was the Bowel Preparation Tolerable?)
timeFrame: During colonoscopy procedure (5-9 hours after completed treatment)
measure: Frequency of Each Category on the Subject Tolerability Questionnaire (How Willing Are You to Use This Preparation in the Future?)
timeFrame: During colonoscopy procedure (5-9 hours after completed treatment)
measure: Frequency of Each Category on the Subject Tolerability Questionnaire (If Difficulties Existed, Were They Due to Your Current Health Status?)
timeFrame: During colonoscopy procedure (5-9 hours after completed treatment)
measure: Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bad Taste in Mouth?)
timeFrame: During colonoscopy procedure (5-9 hours after completed treatment)
measure: Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Gastric Fullness?)
timeFrame: During colonoscopy procedure (5-9 hours after completed treatment)
measure: Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Lack of Sleep From Excessive Bathroom Trips?)
timeFrame: During colonoscopy procedure (5-9 hours after completed treatment)
measure: Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Nausea, Vomiting?)
timeFrame: During colonoscopy procedure (5-9 hours after completed treatment)
measure: Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bloating/Abdominal Distension/Gas?)
timeFrame: During colonoscopy procedure (5-9 hours after completed treatment)
measure: Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Abdominal Pain/Cramps?)
timeFrame: During colonoscopy procedure (5-9 hours after completed treatment)
measure: Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Headache?)
timeFrame: During colonoscopy procedure (5-9 hours after completed treatment)
measure: Frequency of Each Category on the Subject Tolerability Questionnaire (Was This Your First Colonoscopy?)
timeFrame: During colonoscopy procedure (5-9 hours after completed treatment)
measure: Frequency of Each Category on the Subject Tolerability Questionnaire (Previous Bowel Preparation)
timeFrame: During colonoscopy procedure (5-9 hours after completed treatment)
measure: Frequency of Each Category on the Subject Tolerability Questionnaire (Tolerability Compared to Previous Bowel Prepreparations)
timeFrame: During colonoscopy procedure (5-9 hours after completed treatment)
measure: Percentage of Treatment-emergent Adverse Events(AEs)
timeFrame: From baseline (screening) up to day 28 after colonoscopy
measure: Clinically Significant Changes in Vital Signs
timeFrame: From baseline (screening) up to day 28 after colonoscopy
measure: Clinically Significant Changes in Electrocardiogram (ECG)
timeFrame: At baseline (screening), on the day of colonoscopy, 1-2 days after colonoscopy, 7 days after colonoscopy and 28 days after colonoscopy
measure: Clinically Significant Changes in Laboratory Values
timeFrame: At baseline (screening), on the day of colonoscopy, 1-2 days after colonoscopy, 7 days after colonoscopy and 28 days after colonoscopy
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Clinical Research Associates
state: Alabama
city: Anaheim
country: United States
facility: Associated Gastroenterology Medical Group
state: California
city: Chula Vista
country: United States
facility: GW Research, Inc.
state: California
city: San Diego
country: United States
facility: Precision Research Institute
state: California
city: Bristol
country: United States
facility: Connecticut Clinical Research Foundation
state: Connecticut
city: Clearwater
country: United States
facility: Florida Clinical Research Group
state: Florida
city: Inverness
country: United States
facility: Nature Coast Clinical Research
state: Florida
city: Great Neck
country: United States
facility: Long Island Gastrointestinal Research Group LLC
state: New York
city: Kinston
country: United States
facility: Kinston Medical Specialists, PA
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Flourtown
country: United States
facility: Hillmont GI
state: Pennsylvania
city: Ogden
country: United States
facility: Advanced Research Institute
state: Utah
city: Kingston
country: Canada
facility: Hotel Dieu Hospital
city: Toronto
country: Canada
facility: Canadian Phase Onward, Inc.
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
citation: Mankaney GN, Ando M, Dahdal DN, Burke CA. Safety and efficacy of sodium picosulfate, magnesium oxide, and citric acid bowel preparation in patients with baseline renal impairment or diabetes: subanalysis of a randomized, controlled trial. Therap Adv Gastroenterol. 2021 Jun 28;14:17562848211024458. doi: 10.1177/17562848211024458. eCollection 2021.
citation: Hookey L, Bertiger G, Johnson KL 2nd, Boules M, Ando M, Dahdal DN. Efficacy, safety, and tolerability of a ready-to-drink bowel preparation in overweight and obese adults: subanalysis by body mass index from a phase III, assessor-blinded study. Therap Adv Gastroenterol. 2020 Apr 9;13:1756284820910050. doi: 10.1177/1756284820910050. eCollection 2020.
citation: Hookey L, Bertiger G, Johnson KL, Boules M, Ando M, Dahdal DN. Efficacy, safety, and tolerability of a ready-to-drink bowel preparation: subanalysis by age from a phase III, assessor-blinded study. Therap Adv Gastroenterol. 2020 Feb 7;13:1756284820902878. doi: 10.1177/1756284820902878. eCollection 2020.
citation: Hookey L, Bertiger G, Lee Johnson K 2nd, Ayala J, Seifu Y, Brogadir SP. Efficacy and safety of a ready-to-drink bowel preparation for colonoscopy: a randomized, controlled, non-inferiority trial. Therap Adv Gastroenterol. 2019 May 19;12:1756284819851510. doi: 10.1177/1756284819851510. eCollection 2019.