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OpenTrials
Completed

NCT Number: NCT02123017

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

ClinSearch, LLC

Chattanooga, Tennessee, 37421, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients requiring bowel evacuation for colonoscopy.

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.

Treatment and study plan

90 grams of Crystalline Lactulose

Drug

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

135 grams of Crystalline Lactulose

Drug

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

180 grams of Crystalline Lactulose

Drug

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

Primary outcomes

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

    Time frame: 10-14 hours post last consumption

    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.

Secondary outcomes

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

    Time frame: 1 day post last consumption

    Safety determined by the incidence of treatment emergent adverse events.

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

    Time frame: 1 day post last consumption

    Safety determined by the severity of treatment emergent adverse events.

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

    Time frame: 1 day post last consumption

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

Sponsors and collaborators

Lead sponsor

Cumberland Pharmaceuticals

Industry

Registry information

Official study title

An Observer-blinded, Dose-finding Study to Investigate the Safety, Efficacy, and Patient Preference of Lactulose for Oral Solution With Bisacodyl for Cleansing of the Colon as a Preparation for Colonoscopy in Adults

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 25, 2014
Registry last updated
Feb 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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