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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-08-31

Brief Summary

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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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Detailed Description

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Conditions

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Colonoscopy Preparation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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90 grams of Crystalline Lactulose

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

Group Type EXPERIMENTAL

90 grams of Crystalline Lactulose

Intervention Type DRUG

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

135 grams of Crystalline Lactulose

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

Group Type EXPERIMENTAL

135 grams of Crystalline Lactulose

Intervention Type DRUG

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

180 grams of Crystalline Lactulose

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

Group Type EXPERIMENTAL

180 grams of Crystalline Lactulose

Intervention Type DRUG

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

Interventions

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90 grams of Crystalline Lactulose

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

Intervention Type DRUG

135 grams of Crystalline Lactulose

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

Intervention Type DRUG

180 grams of Crystalline Lactulose

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes