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

NCT03017235 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 000253
• Study Type: interventional
• Target: 917
• Locations: 2 countries
• Sites: 14

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.

Conditions

Bowel Preparation

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects Classified as a Responder Defined by "Excellent" or "Good"

  The efficacy of overall colon cleansing in terms of responders was measured by a blinded endoscopist using the Modified Aronchick Scale. Modified Aronchick scale is a 4-point scale that grades colon cleansing as Excellent (\>90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization), Good (\>90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization), Fair (\>90% of mucosa seen, mixture of liquid and semisolid stool, could be suctioned and/or washed) or Inadequate (\<90% of mucosa seen, mixture of semisolid and solid stool which could not be suctioned or washed).The participant is considered to be a responder if overall colon cleansing is "excellent" or "good" on this 4-point scale.

  During colonoscopy procedure (5-9 hours after completed treatment)

Secondary Outcomes (22)

• Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Right Segment of the Colon

  During colonoscopy procedure (5-9 hours after completed treatment)

• Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Transverse Segment of the Colon

  During colonoscopy procedure (5-9 hours after completed treatment)

• Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Left Segment of the Colon

  During colonoscopy procedure (5-9 hours after completed treatment)

• Frequency of Each Category on the Subject Tolerability Questionnaire (How Many Bowel Movements Did You Have in the Week Prior to Starting Colon Preparation?)

  During colonoscopy procedure (5-9 hours after completed treatment)

• Frequency of Each Category on the Subject Tolerability Questionnaire (How Much Bowel Preparation Was Left in Bottle After Drinking it?)

  During colonoscopy procedure (5-9 hours after completed treatment)

Study Arms (2)

NaP/MC Oral Solution

EXPERIMENTAL

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

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

PREPOPIK®

ACTIVE COMPARATOR

Drug: Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder

Interventions

Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution DRUG

Supplied as two 160 mL ready-to-drink bottles, per subject, without further reconstitution, before administration.

NaP/MC Oral Solution

Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder DRUG

Supplied as two sachets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.

Also known as: PREPOPIK®, PicoPrep®

PREPOPIK®

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (14)

Clinical Research Associates

Huntsville, Alabama, 35801, United States

Location

Associated Gastroenterology Medical Group

Anaheim, California, 92801, United States

Location

GW Research, Inc.

Chula Vista, California, 91910, United States

Location

Precision Research Institute

San Diego, California, 92114, United States

Location

Connecticut Clinical Research Foundation

Bristol, Connecticut, 06010, United States

Location

Florida Clinical Research Group

Clearwater, Florida, 33759, United States

Location

Nature Coast Clinical Research

Inverness, Florida, 34452, United States

Location

Long Island Gastrointestinal Research Group LLC

Great Neck, New York, 11023, United States

Location

Kinston Medical Specialists, PA

Kinston, North Carolina, 28501, United States

Location

Wake Research Associates, LLC

Raleigh, North Carolina, 27612, United States

Location

Hillmont GI

Flourtown, Pennsylvania, 19031, United States

Location

Advanced Research Institute

Ogden, Utah, 84405, United States

Location

Hotel Dieu Hospital

Kingston, K7L 5G2, Canada

Location

Canadian Phase Onward, Inc.

Toronto, M3J 2C5, Canada

Location

Related Publications (4)

• 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.

  PMID: 34262611 DERIVED

• 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.

  PMID: 32313553 DERIVED

• 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.

  PMID: 32095161 DERIVED

• 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.

  PMID: 31205487 DERIVED

MeSH Terms

Interventions

picosulfate sodium; Magnesium Oxide; Citric Acid

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds; Citrates; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Global Clinical Compliance
• Organization: Ferring Pharmaceuticals

DKO-Disclosure@ferring.com

+1 833-548-1402

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: January 9, 2017
• First Posted: January 11, 2017
• Study Start: February 20, 2017
• Primary Completion: September 15, 2017
• Study Completion: October 12, 2017
• Last Updated: November 14, 2018
• Results First Posted: November 14, 2018

Record last verified: 2018-10

Locations

US (12); CA (2)