Bowel Cleansing Prior to ColonoscopyPhase 2NCT00771485
Study of Efficacy of Bowel Preparation Before Colonoscopy
A Phase 2 study testing FM-602 and Marketed Bowel Cleanser in people with Bowel Cleansing Prior to Colonoscopy, run by C.B. Fleet Company, Inc. at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of FM-602 as a bowel preparation before colonoscopy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bowel Cleansing Prior to Colonoscopy
- What is being tested?
- FM-602 and Marketed Bowel Cleanser
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2008to Dec 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Are men or nonpregnant women who are scheduled for an elective colonoscopy and who are at least 18 years of age,
- Are, in the opinion of the Investigator, able to communicate with study personnel and comply with the requirements of the study,
- Are able and willing to follow the study-specified testing including the diet and hydration regimen, and
- Have been informed of the nature and risks of the study and have given written informed consent at Screening and before any study-related tests are done.
Who cannot join
- Have any known contraindications to the study procedures or treatment,
- Have clinically significant active cardiovascular disease, including a history of myocardial infarction, within the past 6 months and/or heart failure
- Have known or suspected electrolyte abnormalities, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon, or ileus,
- Have any history of prior colon surgery,
- History of active inflammatory bowel disease,
- Have clinical evidence of dehydration,
Show all 14Show fewer
- Are pregnant or breast-feeding,
- Are unwilling to abstain from alcohol consumption from the day before colonoscopy until discharged from the study,
- Are unwilling to use any prohibited medications, including laxatives, 4 days before receiving the first study dose,
- Have received any investigational agent within 30 days before dosing,
- Have any known or suspected allergies, sensitivity or an unwillingness to consume components of the study medication,
- Known or suspected phenylketonuria (PKU) or sensitivity to products containing phenylalanine, or is on a phenylalanine-reduced diet,
- A history of hemolysis or taking concomitant medications known to precipitate hemolytic reactions,
- Have any other condition which in the Investigator's opinion would make the subject unsuitable for inclusion into the study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Advanced Clinical Research Institute
Anaheim, California, 92801
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, 23320
Cumberland Research Associates, LLC
Fayetteville, North Carolina, 28304
About this study
The purpose of this study is to evaluate the effectiveness of FM-602 as a bowel preparation before colonoscopy.
- Conditions
- Bowel Cleansing Prior to Colonoscopy
- Being tested
- FM-602, Marketed Bowel Cleanser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FM-602Drug
Study of Efficacy of Bowel Preparation Before Colonoscopy
Marketed Bowel CleanserDrug
Marketed bowel cleanser
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: FM-602 |
| 2 | Other | Not described Receives: Drug: Marketed Bowel Cleanser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of bowel cleansing assessed by the examining physician
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 posted13 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionDec 2008
- Study completionDec 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- C.B. Fleet Company, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sherrie McNamara, RN, MSN, MBA, Study director, C.B. Fleet Company, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00771485
- Sponsor's protocol ID
- PL08.01
- Status last verified
- Feb 2012
- First submitted
- 9 Oct 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
- Study of Efficacy of Bowel Preparation Before Colonoscopy
- ClinicalTrials.gov ID
- NCT00771485
- Acronym / sponsor ID
- PL08.01
- Conditions
- Bowel Cleansing Prior to Colonoscopy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- C.B. Fleet Company, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 13 Oct 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 evaluate the effectiveness of FM-602 as a bowel preparation before colonoscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: FM-602 |
| 2 | Other | Drug: Marketed Bowel Cleanser |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Are men or nonpregnant women who are scheduled for an elective colonoscopy and who are at least 18 years of age,
- Are, in the opinion of the Investigator, able to communicate with study personnel and comply with the requirements of the study,
- Are able and willing to follow the study-specified testing including the diet and hydration regimen, and
- Have been informed of the nature and risks of the study and have given written informed consent at Screening and before any study-related tests are done.
Key exclusion criteria (14 listed)
- Have any known contraindications to the study procedures or treatment,
- Have clinically significant active cardiovascular disease, including a history of myocardial infarction, within the past 6 months and/or heart failure
- Have known or suspected electrolyte abnormalities, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon, or ileus,
- Have any history of prior colon surgery,
- History of active inflammatory bowel disease,
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-602Study of Efficacy of Bowel Preparation Before Colonoscopy | Drug | 1 |
| Marketed Bowel CleanserMarketed bowel cleanser | Drug | 2 |
Primary outcome
Effectiveness of bowel cleansing assessed by the examining physician
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.
Related trials for Bowel Cleansing Prior to Colonoscopy
RecruitingPhase 3
A Study to Investigate Bowel Cleansing With PLENVU® Compared to Sodium Picosulfate in Participants Aged 1 to < 18 Years of Age in Preparation for Colonoscopy
Bowel Cleansing Prior to Clinical Procedures
Not yet recruitingPhase 3
A Study to Evaluate the Safety and Effectiveness of MSP01-T for Bowel Cleansing Before a Colonoscopy
Colonoscopy, Bowel Preparation
RecruitingPhase 4
A Trial to Compare Efficacy and Tolerability of Plenvu® and Picoprep® as Cleansing Agents Before Colonoscopy
Colon Disease
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.
Sherrie McNamara, RN, MSN, MBA study director
C.B. Fleet Company, Inc.
3 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-602 and Marketed Bowel Cleanser in people with Bowel Cleansing Prior to Colonoscopy, run by C.B. Fleet Company, Inc. at 3 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 14 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 3 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 assessed by the examining physician (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.