Comparative Study of Lubiprostone and PEG Preparation Versus Conventional PEG Preparation for Colonoscopy

Asian Institute of Gastroenterology, India

Status and phase: Completed; Phase 3

Conditions: Colorectal Carcinoma

Treatments: Drug: Lubiprostone

Study type: Interventional

Funder types: Other

Identifiers

NCT01324284

AIG-GI2011-01

Details and patient eligibility

About

Lubiprostone as an adjunct to the standard bowel preparation regime the quality of bowel preparation can be improved for a good colonoscopic examination without missing lesions and complications.

Full description

Objectives:

1. Primary:

   • Same day Low volume PEG with placebo (Arm 1) versus same day low volume PEG with Lubiprostone (Arm 2)
   • Waiting time for colonoscopic procedure and quality of bowel preparation

2. Secondary:

   • Quality of bowel preparation without Dietary restriction (Modified bowel preparation regime without Fiber diet restrictions)

Enrollment: 442 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. All adult patient referred for colonoscopy to AIG
2. Age 18 - 75 years old

Exclusion criteria

1. Acute GI bleeding.
2. Patient of bowel preparation regime other than excepted for the study.
3. Renal insufficiency.
4. Dementia.
5. Symptomatic heart failure.
6. Recent Myocardial Infarction.
7. Patients with ileus.
8. Suspected bowel obstruction.
9. Prior alimentary tract surgery.
10. Significant gastroparesis.
11. Gastric outlet obstruction.
12. Toxic colitis or megacolon.
13. Pregnant or lactating patients.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

442 participants in 2 patient groups, including a placebo group

Lubiprostone

Experimental group

Description:

Lubiprostone with PEG solution versus Placebo with PEG solution

Treatment:

Drug: Lubiprostone

lubiprostone versus placebo

Placebo Comparator group