Phase 3
N=917
A Study Comparing the Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution With PREPOPIK® for Colon Cleansing in Preparation for Colonoscopy
Bowel Preparation
Bottom Line
View on ClinicalTrials.gov: NCT03017235 ↗Enrolled (actual)
917
Serious AEs
1.7%
Results posted
Nov 2018
Primary outcome: Primary: Percentage of Subjects Classified as a Responder Defined by "Excellent" or "Good" — 87.7; 81.5 Percentage of participants — p=0.0067
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution (Drug); Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ferring Pharmaceuticals
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Classified as a Responder Defined by "Excellent" or "Good" |
87.7; 81.5 | 0.0067 sig |
| SECONDARY Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Right Segment of the Colon |
94.2; 89.6 | 0.0099 sig |
| SECONDARY Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Transverse Segment of the Colon |
96.0; 94.0 | 0.1781 |
| SECONDARY Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Left Segment of the Colon |
94.6; 91.2 | 0.0391 sig |
| SECONDARY Frequency of Each Category on the Subject Tolerability Questionnaire (How Many Bowel Movements Did You Have in the Week Prior to Starting Colon Preparation?) |
63; 47; 264; 299; 120; 105 | — |
| SECONDARY Frequency of Each Category on the Subject Tolerability Questionnaire (How Much Bowel Preparation Was Left in Bottle After Drinking it?) |
443; 448; 1; 1; 0; 2 | — |
| SECONDARY Frequency of Each Category on the Subject Tolerability Questionnaire (Was the Bowel Preparation Tolerable?) |
400; 433; 41; 17; 4; 1 | — |
| SECONDARY Frequency of Each Category on the Subject Tolerability Questionnaire (How Willing Are You to Use This Preparation in the Future?) |
11; 6; 75; 38; 361; 408 | — |
| SECONDARY Frequency of Each Category on the Subject Tolerability Questionnaire (If Difficulties Existed, Were They Due to Your Current Health Status?) |
11; 8; 104; 93; 310; 320 | — |
| SECONDARY Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bad Taste in Mouth?) |
371; 426; 63; 22; 11; 2 | — |
| SECONDARY Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Gastric Fullness?) |
382; 387; 53; 57; 10; 6 | — |
| SECONDARY Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Lack of Sleep From Excessive Bathroom Trips?) |
335; 328; 86; 85; 25; 37 | — |
| SECONDARY Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Nausea, Vomiting?) |
416; 435; 23; 11; 6; 2 | — |
| SECONDARY Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bloating/Abdominal Distension/Gas?) |
403; 402; 35; 40; 7; 6 | — |
| SECONDARY Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Abdominal Pain/Cramps?) |
427; 432; 15; 15; 3; 3 | — |
| SECONDARY Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Headache?) |
396; 396; 38; 47; 13; 7 | — |
| SECONDARY Frequency of Each Category on the Subject Tolerability Questionnaire (Was This Your First Colonoscopy?) |
261; 281; 185; 171; 1; 2 | — |
| SECONDARY Frequency of Each Category on the Subject Tolerability Questionnaire (Previous Bowel Preparation) |
56; 52; 14; 17; 20; 20 | — |
| SECONDARY Frequency of Each Category on the Subject Tolerability Questionnaire (Tolerability Compared to Previous Bowel Prepreparations) |
5; 5; 62; 67; 190; 209 | — |
| SECONDARY Percentage of Treatment-emergent Adverse Events(AEs) |
84.4; 84.8 | — |
| SECONDARY Clinically Significant Changes in Vital Signs |
0; 4; 1; 2; 2; 0 | — |
| SECONDARY Clinically Significant Changes in Electrocardiogram (ECG) |
3; 0; 0; 2; 0; 2 | — |
| SECONDARY Clinically Significant Changes in Laboratory Values |
1; 1; 1; 0; 0; 1 | — |
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
Data sourced from ClinicalTrials.gov (NCT03017235). 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.