Bowel Preparation for ColonoscopyNCT01028573
A Study Comparing PEG-3350 (Miralax) and Gatorade With PEG-ELS (Golytely) for Bowel Preparation Prior to Colonoscopy
A study testing PEG-ELS (Golytely), Miralax mixed with Gatorade and Miralax in people with Bowel Preparation for Colonoscopy, run by Southern California Institute for Research and Education at 1 site in United States.
Trial summary
The purpose of this study to to see how well Miralax (PEG-3350) and Gatorade cleans the colon before a colonoscopy and how easy it is to take compared to Golytely (PEG-ELS) bowel preparation solution. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bowel Preparation for Colonoscopy
- What is being tested?
- PEG-ELS (Golytely), Miralax mixed with Gatorade and Miralax
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Jul 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-80 years in age
- Undergoing full colonoscopy for colorectal cancer screening or colon polyp/cancer surveillance or other diagnostic purpose
Who cannot join
- Allergic to polyethylene glycol
- Pregnant or lactating
- Baseline abnormalities of relevant serum electrolytes including Sodium, Potassium, Calcium, Magnesium and phosphorus
- Congestive Heart Failure NY Heart Assn, Grades III and IV
- Liver Cirrhosis Childs Pugh Class B or C
- Serum Creatinine greater than 1.5
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- Previous alimentary tract surgery
- Ongoing symptoms of abdominal pain, bloating, nausea or constipation
- Ileus, suspected bowel obstruction, toxic colitis or megacolon, severe ulcerative colitis
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
VA Long Beach Healthcare System
Long Beach, California, 90822-5201
Mazen Jamal, MD
About this study
Official title: A Randomized, Controlled, Single-Blind Study Comparing the Efficacy, Tolerability and Safety of PEG-3350 (Miralax) and Gatorade With PEG-ELS (Golytely) for Bowel Preparation Prior to Colonoscopy
The purpose of this study to to see how well Miralax (PEG-3350) and Gatorade cleans the colon before a colonoscopy and how easy it is to take compared to Golytely (PEG-ELS) bowel preparation solution. Another purpose is to see if taking half of the bowel preparation solution on the evening before the colonoscopy and half on the morning of the colonoscopy will result in a cleaner colon than taking all of the bowel preparation solution on the evening before.
- Conditions
- Bowel Preparation for Colonoscopy
- Being tested
- PEG-ELS (Golytely), Miralax mixed with Gatorade, Miralax
- Keywords
- bowel preparation, colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-ELS (Golytely)Drug
4L consumed evening before colonoscopy
PEG-ELS (Golytely)Drug
2L consumed on the evening before and 2L consumed on the morning of Colonoscopy
Miralax mixed with GatoradeDrug
238g of PEG-3350 (Miralax) mixed with 2L of Gatorade consumed on the evening before colonoscopy
MiralaxDrug
1L of PEG-3350 + Gatorade consumed on the evening before and 1L of PEG-3350 + Gatorade consumed on the morning of Colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | 4L of PEG-ELS (Golytely) consumed on the evening before colonoscopy Receives: Drug: PEG-ELS (Golytely) |
| Group 2 | Experimental | 2L of PEG-ELS (Golytely) consumed on the evening before and 2L consumed on the morning of colonoscopy Receives: Drug: PEG-ELS (Golytely) |
| Group 3 | Experimental | 238g of PEG-3350 mixed with 2L of Gatorade Receives: Drug: Miralax mixed with Gatorade |
| Group 4 | Experimental | 1L of PEG-3350 + Gatorade Receives: Drug: Miralax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of bowel prepreparation/cleanliness scored using the Boston Bowel Preparation Scale
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionJul 2012 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel Preparation for ColonoscopyStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southern California Institute for Research and Education
- Sponsor type
- University, hospital or other
- Investigators
- Mazen Jamal, MD, Principal investigator, VA Long Beach Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01028573
- Sponsor's protocol ID
- 976
- Status last verified
- Mar 2012
- First submitted
- 7 Dec 2009
- Last updated
- 14 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Single-Blind Study Comparing the Efficacy, Tolerability and Safety of PEG-3350 (Miralax) and Gatorade With PEG-ELS (Golytely) for Bowel Preparation Prior to Colonoscopy
- ClinicalTrials.gov ID
- NCT01028573
- Acronym / sponsor ID
- 976
- Conditions
- Bowel Preparation for Colonoscopy
- Keywords
- bowel preparation, colonoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Southern California Institute for Research and EducationUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 9 Dec 2009 (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 to to see how well Miralax (PEG-3350) and Gatorade cleans the colon before a colonoscopy and how easy it is to take compared to Golytely (PEG-ELS) bowel preparation solution. Another purpose is to see if taking half of the bowel preparation solution on the evening before the colonoscopy and half on the morning of the colonoscopy will result in a cleaner colon than taking all of the bowel preparation solution on the evening before.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: PEG-ELS (Golytely)4L of PEG-ELS (Golytely) consumed on the evening before colonoscopy |
| Group 2 | Experimental | Drug: PEG-ELS (Golytely)2L of PEG-ELS (Golytely) consumed on the evening before and 2L consumed on the morning of colonoscopy |
| Group 3 | Experimental | Drug: Miralax mixed with Gatorade238g of PEG-3350 mixed with 2L of Gatorade |
| Group 4 | Experimental | Drug: Miralax1L of PEG-3350 + Gatorade |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-80 years in age
- Undergoing full colonoscopy for colorectal cancer screening or colon polyp/cancer surveillance or other diagnostic purpose
Key exclusion criteria (9 listed)
- Allergic to polyethylene glycol
- Pregnant or lactating
- Baseline abnormalities of relevant serum electrolytes including Sodium, Potassium, Calcium, Magnesium and phosphorus
- Congestive Heart Failure NY Heart Assn, Grades III and IV
- Liver Cirrhosis Childs Pugh Class B or C
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 |
|---|---|---|
| PEG-ELS (Golytely)4L consumed evening before colonoscopy | Drug | Group 1 |
| PEG-ELS (Golytely)2L consumed on the evening before and 2L consumed on the morning of Colonoscopy | Drug | Group 2 |
| Miralax mixed with Gatorade238g of PEG-3350 (Miralax) mixed with 2L of Gatorade consumed on the evening before colonoscopy | Drug | Group 3 |
| Miralax1L of PEG-3350 + Gatorade consumed on the evening before and 1L of PEG-3350 + Gatorade consumed on the morning of Colonoscopy | Drug | Group 4 |
Primary outcome
Quality of bowel prepreparation/cleanliness scored using the Boston Bowel Preparation Scale
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2012.
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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.
Mazen Jamal, MD principal investigator
VA Long Beach Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEG-ELS (Golytely), Miralax mixed with Gatorade and Miralax in people with Bowel Preparation for Colonoscopy, run by Southern California Institute for Research and Education 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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 14 Mar 2012. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mazen Jamal, MD ((562) 826-5628, mazen.jamal@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of bowel prepreparation/cleanliness scored using the Boston Bowel Preparation Scale (time frame: two years). 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 14 Mar 2012.