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Phase 4 N=520 Randomized Single-blind Treatment

MoviPrep® Versus GoLYTELY® Bowel Preparation in Hospitalized Patients Undergoing Colonoscopy

Bowel Preparation Before Colonoscopy

Enrolled (actual)
520
Serious AEs
1.2%
Results posted
Mar 2026
Primary outcome: Primary: Number of Participants With Adequate Bowel Preparation — 111; 111 Participants — p=0.007

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
MoviPrep (Drug); Golytely (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Yale University
Primary completion
Jul 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Adequate Bowel Preparation
111; 111 0.007 sig
SECONDARY
Mean Boston-Bowel-Preparation-Scale (BBPS) Score During Colonoscopy Withdrawal For Each Segment
1.91; 1.78; 1.91; 1.90; 2.13; 2.12
SECONDARY
Number of Participants With "Excellent" Bowel Preparation
58; 47
SECONDARY
Cecal Intubation
191; 201
SECONDARY
Cecal Intubation Time
13; 12
SECONDARY
Colonoscopy Withdrawal Time
26; 24
SECONDARY
Time to Colonoscopy
17.1; 17.6
SECONDARY
Hospital Length of Stay
6; 6
SECONDARY
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
104; 121
SECONDARY
Mayo Clinic Bowel Preparation Questionnaire- Tolerability Question 1
164; 164; 12; 20; 2; 2
SECONDARY
Mayo Clinic Bowel Preparation Questionnaire- Tolerability Question 2
54; 26; 74; 60; 34; 78
SECONDARY
Mayo Clinic Bowel Preparation Questionnaire- Tolerability Question 3
29; 43; 64; 89; 92; 67
SECONDARY
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 1
72; 74; 54; 60; 36; 44
SECONDARY
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 2
79; 58; 41; 43; 48; 69
SECONDARY
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 3
55; 48; 36; 35; 52; 58
SECONDARY
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 4
133; 148; 27; 33; 13; 12
SECONDARY
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 5
93; 91; 52; 55; 31; 35
SECONDARY
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 6
123; 123; 29; 42; 21; 27
SECONDARY
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 7
154; 159; 19; 20; 8; 15

Summary

Adequate bowel cleansing is a critical component in the care of hospitalized patients undergoing colonoscopy. However, inpatient status is a well-established risk factor for inadequate bowel preparation. However, few strategies have been rigorously shown to reduce the risk of inadequate bowel preparation. Moreover, inadequate bowel preparation is frequently related to the poor tolerability of high volumes of bowel preparation in the medically complex and comorbid hospitalized population. Low volume bowel preparations have been developed that have been shown to be noninferior compared to high volume bowel preparation with regards to adequacy of bowel preparation but with improved tolerability. However, the use of low volume bowel preparations for colonoscopies have largely been evaluated in the outpatient setting. In this study, we plan to compare rates of adequate bowel preparation and tolerability of a low volume bowel preparation, MoviPrep, compared to standard high volume bowel preparation, GoLYTELY, in hospitalized patients undergoing colonoscopy. This study promises to highlight low volume bowel preparation as a viable and better tolerated alternative to high volume bowel preparation in hospitalized patients which may ultimately decrease delays in inpatient endoscopy as well as hospital length of stay.

Eligibility Criteria

Inclusion Criteria

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Male or female, aged 18 or greater
  • Hospitalized patient scheduled to undergo colonoscopy with bowel preparation (not including preparation with enemas alone)
  • Ability to take bowel preparation and be willing to adhere to the regimen

Exclusion Criteria

  • Patients presenting to the hospital with ileus, toxic megacolon, evidence of gastrointestinal obstruction
  • Receipt of bowel preparation for other reasons during their hospitalization prior to their colonoscopy
  • Patients with prior significant gastrointestinal surgeries including colonic resection, subtotal colectomy, abdomino-perineal resection, Hartmann's procedure or other similar surgeries involving structure/function of small intestine or colon
  • Unable to give informed consent to the procedure
  • Known glucose-6-phosphate dehydrogenase deficiency
  • Known phenylketonuria
  • Known hypersensitivity to polyethylene glycols or ascorbic acid
  • Patients undergoing colonoscopy for foreign body removal and/or decompression
  • Pregnancy or lactating women
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05054036). 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.

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