ColonoscopyNCT00558376
Polyethylene Glycol Versus Sodium Phosphate for Colon Preparation After Failure of First Preparation for Colonoscopy
A study testing polyethylene glycol and Sodium phosphate in people with Colonoscopy, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The aim of the study is to compare the efficacy of Polyethylene glycol versus sodium phosphate as purgative for colon preparation to colonoscopy, after the failure of preparation with sodium phosphate for first colonoscopy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colonoscopy
- What is being tested?
- polyethylene glycol and Sodium phosphate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2008to Mar 2009
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Failed colonoscopy due to inadequate preparation
- Able to understand and sign an informed consent
- Preparation for frst colonoscopy consisted of sodium phosphate
Who cannot join
- Significant heart disease or CHF
- Chronic Renal Failure
- Allergy to any of the purgative ingredients
- Pregnancy
- Alcohol and/or drug abuse
- Vomiting or aspiration
- Suspected bowel obstruction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Polyethylene Glycol Versus Sodium Phosphate for Colon Preparation After Failure of First Preparation for Colonoscopy - An Investigator Blinded Prospective Controlled Trial
The aim of the study is to compare the efficacy of Polyethylene glycol versus sodium phosphate as purgative for colon preparation to colonoscopy, after the failure of preparation with sodium phosphate for first colonoscopy. The hypothesis tested is whether there is advantage for substituting the purgative used, as compared to repeating the colonoscopy with the same purgative.Briefly, patients whose preparation was inadequate, will be allocated randomly to a group that will receive 3L Polyethylene glycol versus a group that will receive sodium phosphate(45ccX2). Both groups will be instructed to extend low-fiber diet to 5 days. Cleanliness of the colon at colonoscopy will be assessed blindly by an experienced endoscopist.
Read the detailed description
The aim of the study is to compare the efficacy of Polyethylene glycol versus sodium phosphate as purgative for colon preparation to colonoscopy, after the failure of preparation with sodium phosphate for first colonoscopy. The hypothesis tested is whether there is advantage for substituting the purgative used, as compared to repeating the colonoscopy with the same purgative.Briefly, the study will be composed of patients whose preparation was judged to be inadequate in a first colonoscopy by an endoscopist independent of the current study. They will be allocated randomly to a group that will receive 3L Polyethylene glycol versus a group that will receive sodium phosphate(45ccX2). Both groups will be instructed to extend low-fiber diet to 5 days. Cleanliness of the colon at colonoscopy will be assessed blindly by an experienced endoscopist.
- Conditions
- Colonoscopy
- Being tested
- polyethylene glycol, Sodium phosphate
- Keywords
- Colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polyethylene glycolDrug
Also called Meroken New, Polyethylene glycol 3350, Taro, Israel
Single time 3 liters PEG, 250 cc every 15 minutes the day before colonoscopy
Sodium phosphateDrug
Also called Sodium phosphate solution; Soffodex, Dexxon, Israel
Sodium phosphate 45cc, 2 doses 4 hours apart the day before colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Ingestion of 3L polyethylene Glycol Receives: Drug: polyethylene glycol |
| 2 | Active comparator | Ingestion of 2 doses of sodium phosphate 45 cc Receives: Drug: Sodium phosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colon cleanliness at the second colonoscopy
Measured: within 24 hours of purgative ingestion, and within 30 minutes of colonoscopy
Secondary outcomes (1)
Tolerability of purgative regimen
Measured: within 24 hours of purgative ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2007 (estimated)
- Study startJan 2008
- Primary completionMar 2009
- Study completionMar 2009
Why it stopped: Study terminated due to FDA alert regarding Fleet phosphosoda
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Prof. Shomron BenHorin, Sheba Medical Center
- Investigators
- Shomron Ben-Horin, MD, Principal investigator, Sheba Medical CenterBenjamin Avidan, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00558376
- Sponsor's protocol ID
- SHEBA-07-4884-SBH-CTIL
- Status last verified
- Jun 2018
- First submitted
- 13 Nov 2007
- Last updated
- 14 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polyethylene Glycol Versus Sodium Phosphate for Colon Preparation After Failure of First Preparation for Colonoscopy - An Investigator Blinded Prospective Controlled Trial
- ClinicalTrials.gov ID
- NCT00558376
- Acronym / sponsor ID
- SHEBA-07-4884-SBH-CTIL
- Conditions
- Colonoscopy
- Keywords
- Colonoscopy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to FDA alert regarding Fleet phosphosoda
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jan 2008 (actual)
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 14 Nov 2007 (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 aim of the study is to compare the efficacy of Polyethylene glycol versus sodium phosphate as purgative for colon preparation to colonoscopy, after the failure of preparation with sodium phosphate for first colonoscopy. The hypothesis tested is whether there is advantage for substituting the purgative used, as compared to repeating the colonoscopy with the same purgative.Briefly, patients whose preparation was inadequate, will be allocated randomly to a group that will receive 3L Polyethylene glycol versus a group that will receive sodium phosphate(45ccX2). Both groups will be instructed to extend low-fiber diet to 5 days. Cleanliness of the colon at colonoscopy will be assessed blindly by an experienced endoscopist.
Detailed description
The aim of the study is to compare the efficacy of Polyethylene glycol versus sodium phosphate as purgative for colon preparation to colonoscopy, after the failure of preparation with sodium phosphate for first colonoscopy. The hypothesis tested is whether there is advantage for substituting the purgative used, as compared to repeating the colonoscopy with the same purgative.Briefly, the study will be composed of patients whose preparation was judged to be inadequate in a first colonoscopy by an endoscopist independent of the current study. They will be allocated randomly to a group that will receive 3L Polyethylene glycol versus a group that will receive sodium phosphate(45ccX2). Both groups will be instructed to extend low-fiber diet to 5 days. Cleanliness of the colon at colonoscopy will be assessed blindly by an experienced endoscopist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: polyethylene glycolIngestion of 3L polyethylene Glycol |
| 2 | Active comparator | Drug: Sodium phosphateIngestion of 2 doses of sodium phosphate 45 cc |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Failed colonoscopy due to inadequate preparation
- Able to understand and sign an informed consent
- Preparation for frst colonoscopy consisted of sodium phosphate
Key exclusion criteria (7 listed)
- Significant heart disease or CHF
- Chronic Renal Failure
- Allergy to any of the purgative ingredients
- Pregnancy
- Alcohol and/or drug abuse
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 |
|---|---|---|
| polyethylene glycolAlso: Meroken New, Polyethylene glycol 3350, Taro, IsraelSingle time 3 liters PEG, 250 cc every 15 minutes the day before colonoscopy | Drug | 1 |
| Sodium phosphateAlso: Sodium phosphate solution; Soffodex, Dexxon, IsraelSodium phosphate 45cc, 2 doses 4 hours apart the day before colonoscopy | Drug | 2 |
Primary outcome
Colon cleanliness at the second colonoscopy
Time frame: within 24 hours of purgative ingestion, and within 30 minutes of colonoscopy
1 secondary outcome
Tolerability of purgative regimen
Time frame: within 24 hours of purgative ingestion
Results and safety
The study was stopped early (reason given: Study terminated due to FDA alert regarding Fleet phosphosoda). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2018.
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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.
Shomron Ben-Horin, MD principal investigator
Sheba Medical Center
Benjamin Avidan, MD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing polyethylene glycol and Sodium phosphate in people with Colonoscopy, run by Sheba Medical Center at 1 site in Israel.
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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 14 Jun 2018. 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 Israel. 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 was stopped early (reason given: Study terminated due to FDA alert regarding Fleet phosphosoda). Results are not available in the source record.
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?
Colon cleanliness at the second colonoscopy (time frame: within 24 hours of purgative ingestion, and within 30 minutes 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 14 Jun 2018.