Bowel CleansingNCT03631446
Drug Use-Results Survey on Picoprep® Combination Powder
An observational study of Bowel Cleansing, run by Ferring Pharmaceuticals at 1 site in Japan.
Trial summary
The purpose of this survey is to confirm safety and efficacy with patients who are administered the Picoprep® for cleansing of intestinal contents for preparation of colonoscopy and colorectal surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bowel Cleansing
- What is being tested?
- Sodium Picosulfate, Magnesium Oxide and Citric Acid
- Type of treatment
- Pill or oral medicine
- How many people
- 1,298 participants
- Where
- 1 siteJapan
- Study dates
- 29 Aug 2017to 31 Dec 2021
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients being prepared for colonoscopy and colorectal surgery
Who may be able to join
- Patients who are administered the Picoprep® for cleansing of intestinal contents for preparation of colonoscopy and colorectal surgery.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Japan1 site
Investigational Site (there may be other sites in this country)
Shibuya City, Tokyo
About this study
The purpose of this survey is to confirm safety and efficacy with patients who are administered the Picoprep® for cleansing of intestinal contents for preparation of colonoscopy and colorectal surgery.
- Conditions
- Bowel Cleansing
- Being tested
- Sodium Picosulfate, Magnesium Oxide and Citric Acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Picosulfate, Magnesium Oxide and Citric AcidDrug
Also called Picoprep®
Combination powder for oral solution
| Study group | Role | What they receive |
|---|---|---|
| Patients administered Picoprep® for bowel cleansing | Patients administered Sodium Picosulfate, Magnesium Oxide and Citric Acid for bowel cleansing Receives: Drug: Sodium Picosulfate, Magnesium Oxide and Citric Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel cleansing assessment for colonoscopy
Assessment of each part of large intestine using a bowel cleanliness rating scale
Measured: 48 hours after drug administration
Bowel cleansing assessment for colorectal surgery
Assessment of each part of large intestine using a bowel cleanliness rating scale
Measured: 48 hours after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start29 Aug 2017
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel CleansingStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,298 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Compliance, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03631446
- Sponsor's protocol ID
- 000311
- Status last verified
- Oct 2021
- First submitted
- 13 Aug 2018
- Last updated
- 18 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Use-Results Survey on Picoprep® Combination Powder
- ClinicalTrials.gov ID
- NCT03631446
- Acronym / sponsor ID
- 000311
- Conditions
- Bowel Cleansing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,298 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 29 Aug 2017 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 15 Aug 2018 (actual)
- 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 survey is to confirm safety and efficacy with patients who are administered the Picoprep® for cleansing of intestinal contents for preparation of colonoscopy and colorectal surgery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients administered Picoprep® for bowel cleansing | – | Drug: Sodium Picosulfate, Magnesium Oxide and Citric AcidPatients administered Sodium Picosulfate, Magnesium Oxide and Citric Acid for bowel cleansing |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients being prepared for colonoscopy and colorectal surgery
Key inclusion criteria (1 listed)
- Patients who are administered the Picoprep® for cleansing of intestinal contents for preparation of colonoscopy and colorectal surgery.
Key exclusion criteria (0 listed)
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 Picosulfate, Magnesium Oxide and Citric AcidAlso: Picoprep®Combination powder for oral solution | Drug | Patients administered Picoprep® for bowel cleansing |
Primary outcome
Bowel cleansing assessment for colonoscopy
Time frame: 48 hours after drug administration
Assessment of each part of large intestine using a bowel cleanliness rating scale
Bowel cleansing assessment for colorectal surgery
Time frame: 48 hours after drug administration
Assessment of each part of large intestine using a bowel cleanliness rating scale
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 18 Jan 2022.
Related trials for Bowel Cleansing
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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.
Global Clinical Compliance study director
Ferring Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bowel Cleansing, run by Ferring Pharmaceuticals at 1 site in Japan.
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 0 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 18 Jan 2022. 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 Japan. 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?
Bowel cleansing assessment for colonoscopy (time frame: 48 hours after drug administration). The study lists 2 primary outcomes in all. 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 18 Jan 2022.