Colorectal CarcinomaPhase 3LubiprostoneNCT01324284
Comparative Study of Lubiprostone and PEG Preparation Versus Conventional PEG Preparation for Colonoscopy
A Phase 3 study testing Lubiprostone in people with Colorectal Carcinoma, run by Asian Institute of Gastroenterology, India.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Carcinoma
- What is being tested?
- Lubiprostone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 442 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Jun 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All adult patient referred for colonoscopy to AIG
- Age 18 - 75 years old
Who cannot join
- Acute GI bleeding.
- Patient of bowel preparation regime other than excepted for the study.
- Renal insufficiency.
- Dementia.
- Symptomatic heart failure.
- Recent Myocardial Infarction.
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- Patients with ileus.
- Suspected bowel obstruction.
- Prior alimentary tract surgery.
- Significant gastroparesis.
- Gastric outlet obstruction.
- Toxic colitis or megacolon.
- Pregnant or lactating patients.
About this study
Official title: Comparative Study of Lubiprostone and PEG Preparation Versus Conventional PEG Preparation to Enhance the Colonoscopy Preparation Quality in an Indian Tertiary Care Center.
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.
Read the detailed description
Objectives:
- 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
- Secondary:
- Quality of bowel preparation without Dietary restriction (Modified bowel preparation regime without Fiber diet restrictions)
- Conditions
- Colorectal Carcinoma
- Being tested
- Lubiprostone
- Keywords
- Lubiprostone, Bowel preparation regime
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LubiprostoneDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Lubiprostone | Experimental | Lubiprostone with PEG solution versus Placebo with PEG solution Receives: Drug: Lubiprostone |
| lubiprostone versus placebo | Placebo comparator | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of bowel preparation in Same day Low volume PEG with placebo versus same day low volume PEG with Lubiprostone
Quality of bowel preparation is based on Boston Bowel Preparation Score (BBPS)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CarcinomaStudies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 442 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rupa Banerjee, Asian Institute of Gastroenterology, India
- Investigators
- Nageshwar D Reddy, MD. DM, Study director, Asian Institute of Gastroenterolgy IndiaRupa Banerjee, MD, Principal investigator, Asian Institute of Gastroenterology, IndiaSaravanan Arjunan, MD, Principal investigator, Asian Institute of Gastroenterology, IndiaManu Tandan, MD DM, Principal investigator, AIG Hyderabad india
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01324284
- Sponsor's protocol ID
- AIG-GI2011-01
- Acronym
- Lubiprostone
- Status last verified
- Apr 2013
- First submitted
- 22 Mar 2011
- Last updated
- 5 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Banerjee R, Chaudhari H, Shah N, Saravanan A, Tandan M, Reddy DN. Addition of Lubiprostone to polyethylene glycol(PEG) enhances the quality & efficacy of colonoscopy preparation: a randomized, double-blind, placebo controlled trial. BMC Gastroenterol. 2016 Oct 13;16(1):133. doi: 10.1186/s12876-016-0542-0.
PubMed 27737636
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Lubiprostone and PEG Preparation Versus Conventional PEG Preparation to Enhance the Colonoscopy Preparation Quality in an Indian Tertiary Care Center.
- ClinicalTrials.gov ID
- NCT01324284
- Acronym / sponsor ID
- Lubiprostone / AIG-GI2011-01
- Conditions
- Colorectal Carcinoma
- Keywords
- Lubiprostone, Bowel preparation regime
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 442 participants (actual)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 29 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objectives:
- 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
- Secondary:
- Quality of bowel preparation without Dietary restriction (Modified bowel preparation regime without Fiber diet restrictions)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lubiprostone | Experimental | Drug: LubiprostoneLubiprostone with PEG solution versus Placebo with PEG solution |
| lubiprostone versus placebo | Placebo comparator | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All adult patient referred for colonoscopy to AIG
- Age 18 - 75 years old
Key exclusion criteria (13 listed)
- Acute GI bleeding.
- Patient of bowel preparation regime other than excepted for the study.
- Renal insufficiency.
- Dementia.
- Symptomatic heart failure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LubiprostoneLubiprostone 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. | Drug | Lubiprostone |
Primary outcome
Quality of bowel preparation in Same day Low volume PEG with placebo versus same day low volume PEG with Lubiprostone
Time frame: 2 months
Quality of bowel preparation is based on Boston Bowel Preparation Score (BBPS)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2013.
- Derived from this study: PubMed 27737636Banerjee R, Chaudhari H, Shah N, Saravanan A, Tandan M, Reddy DN. Addition of Lubiprostone to polyethylene glycol(PEG) enhances the quality & efficacy of colonoscopy preparation: a randomized, double-blind, placebo controlled trial. BMC Gastroenterol. 2016 Oct 13;16(1):133. doi: 10.1186/s12876-016-0542-0.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nageshwar D Reddy, MD. DM study director
Asian Institute of Gastroenterolgy India
Rupa Banerjee, MD principal investigator
Asian Institute of Gastroenterology, India
Saravanan Arjunan, MD principal investigator
Asian Institute of Gastroenterology, India
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lubiprostone in people with Colorectal Carcinoma, run by Asian Institute of Gastroenterology, India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of bowel preparation in Same day Low volume PEG with placebo versus same day low volume PEG with Lubiprostone (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01324284, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2013.