Safety, Efficacy, and Patient Preference of Split-Dose Crystalline Lactulose as a Preparation for Colonoscopy in Adults

NCT01650870 | Completed Phase 2

• 1 other identifier: SplitDose Cryst. Lactulose
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the efficacy of a split-dose regimen of crystalline lactulose for cleansing of the colon as a preparation for colonoscopy, as assessed by the physician's determination of the cleanliness of the colon using the Boston Bowel Prep Scale (BBPS).

Conditions

Colonoscopy

Keywords

Cathartics; Laxatives; Lactulose; Gastrointestinal Agents; Therapeutic Uses; Pharmacologic Actions

Outcome Measures

Primary Outcomes (1)

• Cleanliness of the Colon During Colonoscopy

  To evaluate the primary objective of efficacy of the split-dose, the following endpoint will be measured: o Physician's determination of the cleanliness of the colon will be evaluated by completion of the Boston bowel prep scale.

  Day of the procedure

Secondary Outcomes (4)

• Treatment Failures

  Day of the procedure

• Patient Tolerability and Preference

  Day before and day of colonoscopy

• Colonic Hydrogen and Methane Gas Production

  Day of colonoscopy

• Safety/Adverse Events

  Day before colonoscopy till 7 days after colonoscopy

Study Arms (2)

Evening Only (full-dose)

ACTIVE COMPARATOR

The dosing regimen of Crystalline lactulose will be four 45-gram doses (one dose every 60 minutes for 4 straight hours) taken the evening before the colonoscopy procedure.

Drug: Crystalline Lactulose

Split-dose

EXPERIMENTAL

The dosing regimen of Crystalline lactulose will be three 45-gram doses (one dose every 60 minutes for 3 straight hours) taken the evening before the colonoscopy procedure followed by one 45-gram dose the morning before the colonoscopy procedure.

Drug: Crystalline Lactulose

Interventions

Crystalline Lactulose DRUG

Evening Only (full-dose); Split-dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• 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 Crystalline Lactulose
• 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, previous colonic surgery, gastric retention, bowel perforation, toxic colitis, toxic megacolon, or ileus
• Patients on lactulose therapy or receiving any treatment for chronic constipation
• 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 pregnant or nursing
• Be otherwise unsuitable for the study, in the opinion of the Investigator

Sponsors & Collaborators

• Benaroya Research Institute: lead
• Virginia Mason Hospital/Medical Center: collaborator
• Cumberland Pharmaceuticals: collaborator

Study Sites (1)

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Study Officials

• Otto Lin, MD

  Virginia Mason Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2012
• First Posted: July 26, 2012
• Study Start: July 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: August 8, 2014

Record last verified: 2014-08

Locations

US (1)