Bowel PreparationNCT01093274
Efficacy and Safety of Polyethylene Glycol Compared With Sodium Picosulphate for Bowel Preparation Before Colonoscopy
A study testing Sodium Picosulphate and Polyethylene Glycol in people with Bowel Preparation, run by Rabin Medical Center at 1 site in Israel.
Trial summary
Patients intended for ambulatory colonoscopy will be randomized into 2 groups Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bowel Preparation
- What is being tested?
- Sodium Picosulphate and Polyethylene Glycol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Start not givento not given
- 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
- Ambulatory patients scheduled for elective colonoscopy
- Age 18-80
Who cannot join
- Renal insufficiency (serum creatinine ≥2.0 mg/dl)
- Symptomatic congestive heart failure
- Recent myocardial infarction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Polyethylene Glycol Compared With Sodium Picosulphate for Bowel Preparation Before Colonoscopy, a Prospective Randomized, Controlled Study
Patients intended for ambulatory colonoscopy will be randomized into 2 groups
- Conditions
- Bowel Preparation
- Being tested
- Sodium Picosulphate, Polyethylene Glycol
- Keywords
- colonoscopy, Cathartics, Sodium picosulfate, Polyethylene Glycol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium PicosulphateDrug
2 Sachets
Polyethylene GlycolDrug
Also called Meroken new, Go-Lytely
3 Liters solution
| Study group | Role | What they receive |
|---|---|---|
| Polyethylene glycol | Active comparator | Preparation with Polyethylene Glycol and bisacodyl Receives: Drug: Polyethylene Glycol |
| Picolax | Experimental | Preparation with Sodium Picosulphate and Bisacodyl. Receives: Drug: Sodium Picosulphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients requiring repeat colonoscopy because of poor preparation
Quality of preparation: good, moderate, poor
Measured: quality of preparation will be assessed during colonoscopy
Secondary outcomes (1)
Patient's satisfaction as measured by questionnaire and willingness to repeat same preparation on future examination
Patient satisfaction on questionnaire referring to taste, compliance with protocol, side effects, willingness to repeat preparation.
Measured: Questionnaire will be filled before colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel PreparationStudies 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
- Care provider
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Eyal Gal, MD, Principal investigator, Rabin Medical Center - Beilinson hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01093274
- Sponsor's protocol ID
- Gal001
- Status last verified
- Feb 2010
- First submitted
- 22 Feb 2010
- Last updated
- 25 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Polyethylene Glycol Compared With Sodium Picosulphate for Bowel Preparation Before Colonoscopy, a Prospective Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT01093274
- Acronym / sponsor ID
- Gal001
- Conditions
- Bowel Preparation
- Keywords
- colonoscopy, Cathartics, Sodium picosulfate, Polyethylene Glycol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- First posted
- 25 Mar 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.
Patients intended for ambulatory colonoscopy will be randomized into 2 groups
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polyethylene glycol | Active comparator | Drug: Polyethylene GlycolPreparation with Polyethylene Glycol and bisacodyl |
| Picolax | Experimental | Drug: Sodium PicosulphatePreparation with Sodium Picosulphate and Bisacodyl. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ambulatory patients scheduled for elective colonoscopy
- Age 18-80
Key exclusion criteria (3 listed)
- Renal insufficiency (serum creatinine ≥2.0 mg/dl)
- Symptomatic congestive heart failure
- Recent myocardial infarction
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 |
|---|---|---|
| Sodium Picosulphate2 Sachets | Drug | Picolax |
| Polyethylene GlycolAlso: Meroken new, Go-Lytely3 Liters solution | Drug | Polyethylene glycol |
Primary outcome
Percentage of patients requiring repeat colonoscopy because of poor preparation
Time frame: quality of preparation will be assessed during colonoscopy
Quality of preparation: good, moderate, poor
1 secondary outcome
Patient's satisfaction as measured by questionnaire and willingness to repeat same preparation on future examination
Time frame: Questionnaire will be filled before colonoscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2010.
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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.
Eyal Gal, MD principal investigator
Rabin Medical Center - Beilinson hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium Picosulphate and Polyethylene Glycol in people with Bowel Preparation, run by Rabin 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 2 inclusion and 3 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 25 Mar 2010. 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?
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?
Percentage of patients requiring repeat colonoscopy because of poor preparation (time frame: quality of preparation will be assessed during 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 25 Mar 2010.