2 Regimens of Lactulose for Colonoscopy Preparation in Adults

NCT01887470 | Completed Phase 2 Results

• 1 other identifier: CPI-KR-004
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine the efficacy of 2 regimens of lactulose as a preparation for colonoscopy.

Conditions

Colonoscopy Preparation

Keywords

Bowel Evacuation; Colonoscopy Preparation

Outcome Measures

Primary Outcomes (1)

• Efficacy of Lactulose as a Preparation for Colonoscopy.

  Efficacy assessed by the physician's determination of the cleanliness of the colon using the cumulative Boston Bowel Preparation Scale (BBPS) score. The cumulative score is derived from three segmental scores assessed from the following three colonic segments: right colon, transverse colon, and left colon. Segment scores range from 0 to 3 with the following abbreviated definitions: 0=mucosa not visible; 1=a portion of the mucosa is visible; 2=minor residue, but mucosa is seen well; 3=entire mucosa is seen well with no residue. The cumulative BBPS score is the sum of the three segment scores such that a cumulative score of 9 represents a colon with maximum mucosa visible and a score of 0 represents minimal visibility.

  at least 3 hours post last consumption

Secondary Outcomes (9)

• Incidence of Treatment Failure

  at least 3 hours post last consumption

• Tolerability of and Preference for Lactulose as a Bowel Evacuant-Patient Visual Analog Scale (VAS)

  3 - 15 hours post last consumption

• Tolerability of and Preference for Lactulose as a Bowel Evacuant-Likert 1

  3-15 hours post last consumption

• Tolerability of and Preference for Lactulose as a Bowel Evacuant-Likert 2

  3-15 hours post last consumption

• Tolerability of and Preference for Lactulose as a Bowel Evacuant-Likert 3

  3 - 15 hours post last consumption

Study Arms (4)

Full dose preparation; AM colonoscopy

EXPERIMENTAL

Four hourly doses of lactulose for oral solution are taken in the evening. The colonoscopy is initiated prior to noon on the following day.

Drug: Full dose preparation

Full dose preparation; PM colonoscopy

EXPERIMENTAL

Four hourly doses of lactulose for oral solution are taken in the evening. The colonoscopy is initiated after noon on the following day.

Drug: Full dose preparation

Split dose preparation; AM colonoscopy

EXPERIMENTAL

Three hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure; one dose is taken on the morning of the procedure. The colonoscopy is initiated prior to noon.

Drug: Split dose preparation

Split dose preparation; PM colonoscopy

EXPERIMENTAL

Three hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure; one dose is taken on the morning of the procedure. The colonoscopy is initiated after noon.

Drug: Split dose preparation

Interventions

Full dose preparation DRUG

Also known as: Evening-only Regimen

Full dose preparation; AM colonoscopy; Full dose preparation; PM colonoscopy

Split dose preparation DRUG

Split dose preparation; AM colonoscopy; Split dose preparation; PM colonoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients requiring bowel evacuation for colonoscopy.

You may not qualify if:

• Patients with galactosemia (galactose-sensitive diet).
• Patients known to be hypersensitive to any of the components of lactulose for oral solution.
• Patients with an abnormality on screening blood work or 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.
• Patients on lactulose therapy or receiving any treatment for chronic constipation.
• Be pregnant or nursing.
• Patients with known large polyps or flat polyps (i.e. polyps requiring 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.

Sponsors & Collaborators

• Cumberland Pharmaceuticals: lead

Study Sites (1)

ClinSearch, LLC

Chattanooga, Tennessee, 37421, United States

Location

Results Point of Contact

• Title: Amy Rock, PhD
• Organization: Cumberland Pharmaceuticals, Inc.

arock@cumberlandpharma.com

615-255-0068

Study Officials

• Richard Krause, M.D

  ClinSearch, LLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2013
• First Posted: June 26, 2013
• Study Start: July 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: June 1, 2015
• Results First Posted: June 1, 2015

Record last verified: 2015-05

Locations

US (1)