Bubbles in Colon at Time of ColonoscopyNCT01209806
The Effects of Moviprep With Simethicone on Colonic Bubbles
A study testing simethicone in people with Bubbles in Colon at Time of Colonoscopy, run by Thomas Jefferson University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether the administration of PEG along with simethicone will reduce the incidence of colonic bubbles that interfere with polyp detection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bubbles in Colon at Time of Colonoscopy
- What is being tested?
- simethicone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Sep 2012
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Elective outpatients undergoing colonoscopy using split dose PEG-ELS with sodium ascorbate and ascorbic acid
Who cannot join
- Unable or unwilling to give informed consent
- Age < 18 years
- Pregnant
- Breast feeding
- Established or suspected gastroparesis
- Pseudo-obstruction - established or suspected
Show all 14Show fewer
- Severe constipation (< 1 BM a week)
- Bowel obstruction
- Greater than 50% resection of colon
- Chronic nausea or vomiting
- Consumed > 100% standard dose of PEG-ELS (i.e. more than 2L)
- G6PD deficiency
- PEG allergy
- Significant psychiatric illness
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
The purpose of this study is to determine whether the administration of PEG along with simethicone will reduce the incidence of colonic bubbles that interfere with polyp detection.
Read the detailed description
evaluating if simethicone is better than placebo at decreasing gas in the colon at time of colonoscopy so that it is easier for the endoscopist to see polyps
- Conditions
- Bubbles in Colon at Time of Colonoscopy
- Being tested
- simethicone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simethiconeDrug
Also called Alka-Seltzer® Gas Relief Maximum Strength Softgels®, Flatulex® Drops, GasAid® Maximum Strength Softgels®, Gas-X®
400 mg simethicone at 6pm night prior to colonoscopy 400 mg simethicone 4 hours before colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| simethicone | Active comparator | Not described Receives: Drug: simethicone |
| no simethicone | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy - Entire colon
Successful cleansing defined as score or excellent or good Unsuccessful cleansing defined as score of fair or inadequate
Measured: At time of colonoscopy
Secondary outcomes (5)
Efficacy - Right colon
Successful cleansing defined as score or excellent or good Unsuccessful cleansing defined as score of fair or inadequate
Measured: At time of colonoscopy
Adenoma detection
Defined as number of adenoma/patient Secondarily evaluate % of patients with at least 1 adenoma
Measured: at time of colonoscopy
Flushing
Defined as need for any (1, 2, or 3) flushing
- 0 = none, 1 = <50 ml, 2 = 50-100 ml, 3 = >100 ml
Measured: at time of colonoscopy
Tolerance
Prep completion
- Completion defined as consuming > 90%
Sleep
- Primary definition as quality of sleep
- Also evaluate duration of sleep Overall satisfaction
- Use visual analogue (Likert) scale Adverse events - nausea, vomiting, abdominal pain, bloating, light-headedness
- Primary is incidence
- Secondary is severity using Likert scale
Measured: during prep ingestion
Safety
Vitals with orthostatic measures (BP, Pulse) day of colonoscopy Physical exam
Measured: at time of colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2010 (estimated)
- Study startNov 2009
- Primary completionAug 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bubbles in Colon at Time of ColonoscopyStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Kastenberg, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01209806
- Sponsor's protocol ID
- #09D.472
- Status last verified
- Jul 2019
- First submitted
- 12 Jul 2010
- Last updated
- 15 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Moviprep With Simethicone on Colonic Bubbles
- ClinicalTrials.gov ID
- NCT01209806
- Acronym / sponsor ID
- #09D.472
- Conditions
- Bubbles in Colon at Time of Colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 27 Sep 2010 (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.
The purpose of this study is to determine whether the administration of PEG along with simethicone will reduce the incidence of colonic bubbles that interfere with polyp detection.
Detailed description
evaluating if simethicone is better than placebo at decreasing gas in the colon at time of colonoscopy so that it is easier for the endoscopist to see polyps
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| simethicone | Active comparator | Drug: simethicone |
| no simethicone | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Elective outpatients undergoing colonoscopy using split dose PEG-ELS with sodium ascorbate and ascorbic acid
Key exclusion criteria (14 listed)
- Unable or unwilling to give informed consent
- Age < 18 years
- Pregnant
- Breast feeding
- Established or suspected gastroparesis
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 |
|---|---|---|
| simethiconeAlso: Alka-Seltzer® Gas Relief Maximum Strength Softgels®, Flatulex® Drops, GasAid® Maximum Strength Softgels®, Gas-X®400 mg simethicone at 6pm night prior to colonoscopy 400 mg simethicone 4 hours before colonoscopy | Drug | simethicone |
Primary outcome
Efficacy - Entire colon
Time frame: At time of colonoscopy
Successful cleansing defined as score or excellent or good Unsuccessful cleansing defined as score of fair or inadequate
5 secondary outcomes
Efficacy - Right colon
Time frame: At time of colonoscopy
Adenoma detection
Time frame: at time of colonoscopy
Flushing
Time frame: at time of colonoscopy
Tolerance
Time frame: during prep ingestion
Safety
Time frame: at time of colonoscopy
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 15 Jul 2019.
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.
David Kastenberg, MD principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing simethicone in people with Bubbles in Colon at Time of Colonoscopy, run by Thomas Jefferson University at 1 site in United States.
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 1 inclusion and 14 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 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Efficacy - Entire colon (time frame: At time of colonoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2019.