CClinicalTrials.gg
Sign In
CompletedNCT02123017Updated Feb 24, 2016Results posted

Efficacy and Safety of Bisacodyl and Lactulose as a Preparation for Colonoscopy

A Phase 2 interventional study of 90 grams of Crystalline Lactulose and 135 grams of Crystalline Lactulose in Colonoscopy Preparation, sponsored by Cumberland Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-02-24.

Sponsored by Cumberland Pharmaceuticals · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
32
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of the study is to evaluate the efficacy and safety of bisacodyl combined with escalating doses of lactulose to be used as a preparation for colonoscopy.

02

Conditions studied

  • Colonoscopy Preparation

Keywords

  • Bowel Evacuation
  • Colonoscopy Preparation
03

In context

Lead sponsor

Cumberland Pharmaceuticals is the lead sponsor of 47 studies on the registry; 1 is open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Patients requiring bowel evacuation for colonoscopy.

Exclusion criteria

Exclusion Criteria:

  • Patients with galactosemia (galactose-sensitive diet).
  • Patients known to be hypersensitive to any of the components of lactulose for oral solution.
  • Patients with a known abnormality on screening or a vital sign assessments that, in the Investigator's judgment, may pose a significant risk including those pertaining to dehydration or electrolyte shifts.
  • Patients with a history of impaired renal function.
  • Patients with current or recent history of hypotension, as defined by the Investigator.
  • Patients with a history of long Q-T syndrome.
  • Patients with a history of a failed bowel preparation.
  • Patients with severe constipation, defined as those patients taking daily prescription or over-the-counter laxatives.
  • Patients with possible bowel obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon, ileus or previous colonic surgery (except hemorrhoidectomy and polypectomy).
  • Patients on lactulose therapy or receiving any treatment for chronic constipation.
  • Be pregnant or nursing.
  • Patients expected to require electrocautery or argon plasma coagulation.
  • Patients less than 18 years of age.
  • Inability to understand the requirements of the study or be unwilling to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board [IRB]) and agree to abide by the study restrictions.
  • Be otherwise unsuitable for the study, in the opinion of the Investigator.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
Single (Investigator)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    90 grams of Crystalline Lactulose

    15 mg of bisacodyl, plus 30 grams of crystalline lactulose x three doses

    Drug: 90 grams of Crystalline Lactulose

  • Experimental
    135 grams of Crystalline Lactulose

    15 mg of bisacodyl, plus 45 grams of crystalline lactulose x three doses

    Drug: 135 grams of Crystalline Lactulose

  • Experimental
    180 grams of Crystalline Lactulose

    15 mg of bisacodyl, plus 60 grams of crystalline lactulose x three doses

    Drug: 180 grams of Crystalline Lactulose

Interventions

  • Drug90 grams of Crystalline Lactulose

    15 mg of bisacodyl, plus 30 grams crystalline lactulose x 3 doses

  • Drug135 grams of Crystalline Lactulose

    15 mg of bisacodyl, plus 45 grams crystalline lactulose x 3 doses

  • Drug180 grams of Crystalline Lactulose

    15 mg of bisacodyl, plus 60 grams crystalline lactulose x 3 doses

06

What researchers measure

Primary outcomes

  1. Efficacy of Bisacodyl and Lactulose as a Preparation for Colonoscopy.

    Efficacy assessed by the physician's determination of the cleanliness of the colon using the Boston Bowel Preparation Scale (BBPS). 9 is the maximum score, representing an fully cleansed colon; 0 is the minimal score, representing a colon with no cleaning.

    Time frame: 10-14 hours post last consumption

Secondary outcomes

  1. Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Incidence

    Safety determined by the incidence of treatment emergent adverse events.

    Time frame: 1 day post last consumption

  2. Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Severity

    Safety determined by the severity of treatment emergent adverse events.

    Time frame: 1 day post last consumption

  3. Tolerability of and Preference for Bisacodyl and Lactulose as a Bowel Evacuant

    Tolerability assessed by a patient questionnaire. Overall tolerability as given by Visual Analog Scale (VAS): 100 represents maximally tolerable; 0 represents minimally tolerable

    Time frame: 1 day post last consumption

07

Results

Posted Feb 24, 2016

Participant flow

Participant flow — Overall Study
Milestone90 Grams Crystalline Lactulose135 Grams Crystalline Lactulose180 Grams Crystalline Lactulose
Started81212
Completed81212
Not completed000

Outcome measures

PrimaryEfficacy of Bisacodyl and Lactulose as a Preparation for Colonoscopy.

Efficacy assessed by the physician's determination of the cleanliness of the colon using the Boston Bowel Preparation Scale (BBPS). 9 is the maximum score, representing an fully cleansed colon; 0 is the minimal score, representing a colon with no cleaning.

Time frame:
10-14 hours post last consumption
Reported as:
Mean · units on a scale
Efficacy of Bisacodyl and Lactulose as a Preparation for Colonoscopy.
units on a scale90 Grams of Crystalline Lactulose135 Grams of Crystalline Lactulose180 Grams of Crystalline Lactulose
Efficacy of Bisacodyl and Lactulose as a Preparation for Colonoscopy.5.7 ± 2.87.4 ± 0.97.8 ± 0.8
SecondarySafety of Bisacodyl and Lactulose as a Bowel evacuant_AE Incidence

Safety determined by the incidence of treatment emergent adverse events.

Time frame:
1 day post last consumption
Reported as:
Number · % of patients with adverse events
Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Incidence
% of patients with adverse events90 Grams of Crystalline Lactulose135 Grams of Crystalline Lactulose180 Grams of Crystalline Lactulose
Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Incidence253350
SecondarySafety of Bisacodyl and Lactulose as a Bowel evacuant_AE Severity

Safety determined by the severity of treatment emergent adverse events.

Time frame:
1 day post last consumption
Reported as:
Number · Percentage of subjects
Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Severity
Percentage of subjects90 Grams of Crystalline Lactulose135 Grams of Crystalline Lactulose180 Grams of Crystalline Lactulose
Mild02550
Moderate2580
Severe000
SecondaryTolerability of and Preference for Bisacodyl and Lactulose as a Bowel Evacuant

Tolerability assessed by a patient questionnaire. Overall tolerability as given by Visual Analog Scale (VAS): 100 represents maximally tolerable; 0 represents minimally tolerable

Time frame:
1 day post last consumption
Reported as:
Mean · units on a VAS scale
Tolerability of and Preference for Bisacodyl and Lactulose as a Bowel Evacuant
units on a VAS scale90 Grams of Crystalline Lactulose135 Grams of Crystalline Lactulose180 Grams of Crystalline Lactulose
Tolerability of and Preference for Bisacodyl and Lactulose as a Bowel Evacuant65.4 ± 27.668.5 ± 19.671.3 ± 18.4

Adverse events

Collected over Adverse Events were collected from the first dose of study drug through the end of the observation period after the colonoscopy (Day 2).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
90 Grams of Crystalline Lactulose—0/8 (0%)2/8 (25%)
135 Grams of Crystalline Lactulose—0/12 (0%)4/12 (33.3%)
180 Grams of Crystalline Lactulose—0/12 (0%)6/12 (50%)
Most frequent other events
Most frequent other events
Event90 Grams of Crystalline Lactulose135 Grams of Crystalline Lactulose180 Grams of Crystalline Lactulose
Procedural hypotensionVascular disorders0/84/126/12
VomitingGastrointestinal disorders2/82/120/12
Abdominal PainGastrointestinal disorders0/81/120/12
NauseaGastrointestinal disorders0/81/120/12

Baseline characteristics

All patients adhered to the one set of study-level eligibility criteria.

Age, Continuous
Age, Continuous(years)90 Grams of Crystalline Lactulose135 Grams of Crystalline Lactulose180 Grams of Crystalline LactuloseTotal
Subject Age at Enrollment47.4 ± 6.257.0 ± 7.458.1 ± 8.755.0 ± 8.7
Sex: Female, Male
Sex: Female, Male(Participants)90 Grams of Crystalline Lactulose135 Grams of Crystalline Lactulose180 Grams of Crystalline LactuloseTotal
Female48921
Male44311
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)90 Grams of Crystalline Lactulose135 Grams of Crystalline Lactulose180 Grams of Crystalline LactuloseTotal
Hispanic or Latino1012
Not Hispanic or Latino7121130
Unknown or Not Reported0000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)90 Grams of Crystalline Lactulose135 Grams of Crystalline Lactulose180 Grams of Crystalline LactuloseTotal
American Indian or Alaska Native0000
Asian0000
Native Hawaiian or Other Pacific Islander0000
Black or African American0123
White8111029
More than one race0000
Unknown or Not Reported0000
08

Study locations

1 site
  • ClinSearch, LLC
    Chattanooga, Tennessee 37421, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02123017
Lead sponsor
Cumberland Pharmaceuticals
Responsible party
Sponsor
First posted
Apr 25, 2014
Start date
Apr 2014
Primary completion
Aug 2014
Completion
Aug 2014
Results posted
Feb 24, 2016
Last update
Feb 24, 2016

Study contacts

Richard Krause, MD
principal investigator · ClinSearch, LLC

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Cumberland Pharmaceuticals

Start the discussion