Bowel Cleansing Prior to ColonoscopyPhase 2NCT00621920
Efficacy Study of Bowel Preparation Before Colonoscopy
A Phase 2 study testing FM-601 in people with Bowel Cleansing Prior to Colonoscopy, run by C.B. Fleet Company, Inc. at 2 sites in United States.
Trial summary
The purpose of this study is to determine the efficacious dose range when used as a bowel preparation before colonoscopy. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bowel Cleansing Prior to Colonoscopy
- What is being tested?
- FM-601
- How many people
- 72 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2008to Apr 2008
- Phase
- Phase 2
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and nonpregnant women who are scheduled for an elective colonoscopy and who are at least 50 years of age.
- Are able to communicate with study personnel and comply with study requirements.
- Are able and willing to follow study-specified testing, diet, and hydration regimen.
- Have been informed of the nature and risks of the study and have given written informed consent.
Who cannot join
- Have known or suspected liver disease or any history of abnormal liver function tests.
- Have clinically active cardiovascular disease within the past 6 months.
- Have blood pressure greater than 150/90 mm Hg.
- Have known or suspected renal insufficiency.
- Have known or suspected electrolyte abnormalities, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon, or ileus.
- Have a history of prior bowel surgery within 2 years before enrollment, or active inflammatory bowel disease.
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- Have diabetes or a history of diabetes.
- Have clinical evidence of dehydration.
- Are pregnant or breast-feeding.
- Are unwilling to abstain from alcohol consumption from one day before colonoscopy until discharged from the study.
- Use prohibited medications of the study in the defined timeframes.
- Have received any investigational agent within 30 days before dosing.
- Have any known contraindications to the study treatment.
- Have any known or suspected allergies to the components of the study medication.
- Have any other condition which would make the subject unsuitable for inclusion in the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Advanced Clinical Research Institute
Anaheim, California, 92801
Qualia Clinical Services
Omaha, Nebraska, 68154
About this study
The purpose of this study is to determine the efficacious dose range when used as a bowel preparation before colonoscopy.
- Conditions
- Bowel Cleansing Prior to Colonoscopy
- Being tested
- FM-601
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FM-601Drug
Dose-escalation, split dosage, liquid
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of bowel cleansing based on a grading scale.
Measured: During colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel Cleansing Prior to 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- C.B. Fleet Company, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00621920
- Sponsor's protocol ID
- PL07.01
- Status last verified
- Feb 2012
- First submitted
- 12 Feb 2008
- Last updated
- 10 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Study of Bowel Preparation Before Colonoscopy
- ClinicalTrials.gov ID
- NCT00621920
- Acronym / sponsor ID
- PL07.01
- Conditions
- Bowel Cleansing Prior to Colonoscopy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- C.B. Fleet Company, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 22 Feb 2008 (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 the efficacious dose range when used as a bowel preparation before colonoscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and nonpregnant women who are scheduled for an elective colonoscopy and who are at least 50 years of age.
- Are able to communicate with study personnel and comply with study requirements.
- Are able and willing to follow study-specified testing, diet, and hydration regimen.
- Have been informed of the nature and risks of the study and have given written informed consent.
Key exclusion criteria (15 listed)
- Have known or suspected liver disease or any history of abnormal liver function tests.
- Have clinically active cardiovascular disease within the past 6 months.
- Have blood pressure greater than 150/90 mm Hg.
- Have known or suspected renal insufficiency.
- Have known or suspected electrolyte abnormalities, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon, or ileus.
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 |
|---|---|---|
| FM-601Dose-escalation, split dosage, liquid | Drug | – |
Primary outcome
Effectiveness of bowel cleansing based on a grading scale.
Time frame: During 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 10 Feb 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FM-601 in people with Bowel Cleansing Prior to Colonoscopy, run by C.B. Fleet Company, Inc. at 2 sites 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 4 inclusion and 15 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 10 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Effectiveness of bowel cleansing based on a grading scale. (time frame: 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 10 Feb 2012.