Colonoscopy
Conditions
Keywords
colonoscopy, preparation
Brief summary
To compare the safety and efficacy of 2 different bowel cleansing preparations prior to colonoscopy in adult subjects.
Detailed description
The goal of the study is to evaluate the efficacy of 2 different HalfLytely preparations to produce a clinically acceptable degree of cleansing of the bowel, sufficient for colonoscopy.
Interventions
DRUGHalfLytely - Reformulation
DRUGHalfLytely with Bisacodyl Tablets Bowel Prep Kit
Sponsors
Braintree Laboratories
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Male or female outpatients who are undergoing colonoscopy for the following routinely accepted indications: Evaluation of BE results GI bleeding Anemia of unknown etiology Neoplastic disease surveillance Endosonography Inflammatory bowel disease Unknown diarrhea or constipation etiology Polypectomy Laser therapy Routine Screening * At least 18 years of age * Otherwise in good health, as determined by physical exam and medical history * If female, and of child-bearing potential, is using an acceptable form of birth control (hormonal birth control, IUD, double-barrier method, depot contraceptive, sterilized, abstinent, or vasectomized spouse) * Negative urine pregnancy test at screening, if applicable * In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study
Exclusion criteria
* Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, or toxic megacolon * Subjects with impaired consciousness that predisposes them to pulmonary aspiration * Subjects who are undergoing colonoscopy for foreign body removal and decompression * Subjects with pre-existing electrolyte disturbances, such as dehydration, or those secondary to the use of diuretics * Subjects who are taking drugs that may affect electrolyte levels * Subjects taking laxatives or prokinetic agents that refuse to discontinue these treatments for the duration of the study * Subjects with known clinically significant electrolyte abnormalities such as hypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia * Subjects who are pregnant or lactating, or intending to become pregnant during the study * Subjects of childbearing potential who refuse a pregnancy test * Subjects who are allergic to any preparation components * Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures * Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy - preparation quality using a 4-point scale | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety - patient-reported preparation related side-effects | — |
Countries
United States
Outcome results
None listed