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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

442 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2011-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of a Low-Cost High Resolution Microendoscope for the Detection of Lower Gastrointestinal Neoplasia

NCT01384240

Colon Polyps Colonic Dysplasia Anal Dysplasia

TERMINATED EARLY_PHASE1

Cytological Screening for Early Diagnosis of Precancerous or Cancerous Lesions of Oral Cavity

NCT02604121

Mouth Neoplasms

COMPLETED NA

Endoscopic Ultrasound-guided Versus Surgical Gastroenterostomy for Malignant Gastric Outlet Obstruction

NCT05564143

Malignant Gastric Outlet Obstruction

UNKNOWN NA

Quality of Life in Patients With Inoperable Malignant Bowel Obstruction

NCT02365584

Intestinal Obstruction

TERMINATED PHASE2

Endoscopic Submucosal Dissection Versus Laparoscopic Resection for Early Colorectal Neoplasms

NCT01112046

Colorectal Neoplasms

UNKNOWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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)

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colorectal Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lubiprostone

Lubiprostone with PEG solution versus Placebo with PEG solution

Group Type EXPERIMENTAL

Lubiprostone

Intervention Type DRUG

Lubiprostone is a chloride channel activator approved by the Food and Drug Administration for the treatment of chronic constipation. A randomized, double-blind, parallel-group, placebo-controlled study evaluating the effect of lubiprostone on gastric function showed slowed gastric emptying and increased small bowel and colonic transit time. Peak plasma concentration was shown to be around 1.14 hours, with a majority of the drug excreted in the urine within 48 hours.

lubiprostone versus placebo

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lubiprostone

Lubiprostone is a chloride channel activator approved by the Food and Drug Administration for the treatment of chronic constipation. A randomized, double-blind, parallel-group, placebo-controlled study evaluating the effect of lubiprostone on gastric function showed slowed gastric emptying and increased small bowel and colonic transit time. Peak plasma concentration was shown to be around 1.14 hours, with a majority of the drug excreted in the urine within 48 hours.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes