ColonoscopyPhase 2NCT00321230
Clinical Evaluation of a New Reduced Volume Bowel Preparation
A Phase 2 study testing macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate in people with Colonoscopy, run by Norgine at 1 site in France.
Trial summary
Monocentric, cleansing evaluation pilot study in patients undergoing colonoscopy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Colonoscopy
- What is being tested?
- macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2001to May 2001
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or female, inpatients 18 to 65 years old with indication for complete colonoscopy
- the patient's written informed consent must be obtained prior to inclusion
- willing and able to complete the entire procedure and to comply with study instructions
Who cannot join
- ileus or toxic megacolon
- intestinal obstruction or perforation
- known of G6PD insufficiency
- history of any colonic surgery
- ischaemic cardiovascular disease
- untreated or uncontrolled arterial hypertension (max >170mmHg, min >100mmHg)
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- renal insufficiency (creating above 45µmol/l)
- abnormal laboratory values (clinically significant) for sodium, potassium,chloride, creatinine and hematocrit
- cirrhosis of liver (Child-Pugh grade B or C)
- females who are pregnant, nursing or planning a pregnancy. Females of child bearing potential not using reliable methods of contraception.
- concurrent participation in an investigational drug study or participation within 30 days of study entry
- subject has a condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound the study results or may interfere significantly
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Monocentric, Open Phase II Study to Investigate the Efficacy and Safety of a New Oral Gut Cleansing Solution ("Low Dose Bowel Prep") in 30 Patients Submitted to Colonoscopy
Monocentric, cleansing evaluation pilot study in patients undergoing colonoscopy.
Read the detailed description
Open prospective pilot monocentric phase II clinical trial evaluating the therapeutic efficacy of a new "Low Dose Bowel Prep" formulation for gut cleansing prior to colonoscopy.
Thirty patients admitted to the hospital (inpatients) planned to undergo a complete colonoscopy will have gut cleansing with the "Low Dose Bowel Prep" using a one-step intake mode.
- Conditions
- Colonoscopy
- Being tested
- macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate
- Keywords
- Colon cleansing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy measured by a final scoring system i.e., "the overall quality of colonoscopy prep" that will be graded (from A to C) and assessed from the degree of cleansing in a 0 - 4 grade scale for each of the predefined colon areas.
Secondary outcomes (2)
Stool weight as recorded on the case report form for each stool as from start of gut cleansing (day -1) to the beginning of colonoscopy (day 0).
Amount of fluid removed from the colon during the colonoscopy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2006 (estimated)
- Study startJan 2001
- Study completionMay 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Norgine
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Alain Bitoun, MD, Principal investigator, Hopital Lariboisière
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00321230
- Sponsor's protocol ID
- NRL994-02/2000
- Other IDs
- 02/2000
- Status last verified
- Apr 2008
- First submitted
- 2 May 2006
- Last updated
- 16 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Davis GR, Santa Ana CA, Morawski SG, Fordtran JS. Development of a lavage solution associated with minimal water and electrolyte absorption or secretion. Gastroenterology. 1980 May;78(5 Pt 1):991-5.
PubMed 7380204
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Monocentric, Open Phase II Study to Investigate the Efficacy and Safety of a New Oral Gut Cleansing Solution ("Low Dose Bowel Prep") in 30 Patients Submitted to Colonoscopy
- ClinicalTrials.gov ID
- NCT00321230
- Acronym / sponsor ID
- NRL994-02/2000
- Conditions
- Colonoscopy
- Keywords
- Colon cleansing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- NorgineIndustry (pharma, biotech, devices)
- Study start
- Jan 2001
- Study completion
- May 2001
- First posted
- 3 May 2006 (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.
Monocentric, cleansing evaluation pilot study in patients undergoing colonoscopy.
Detailed description
Open prospective pilot monocentric phase II clinical trial evaluating the therapeutic efficacy of a new "Low Dose Bowel Prep" formulation for gut cleansing prior to colonoscopy.
Thirty patients admitted to the hospital (inpatients) planned to undergo a complete colonoscopy will have gut cleansing with the "Low Dose Bowel Prep" using a one-step intake mode.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- male or female, inpatients 18 to 65 years old with indication for complete colonoscopy
- the patient's written informed consent must be obtained prior to inclusion
- willing and able to complete the entire procedure and to comply with study instructions
Key exclusion criteria (12 listed)
- ileus or toxic megacolon
- intestinal obstruction or perforation
- known of G6PD insufficiency
- history of any colonic surgery
- ischaemic cardiovascular 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 |
|---|---|---|
| macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate | Drug | – |
Primary outcome
Efficacy measured by a final scoring system i.e., "the overall quality of colonoscopy prep" that will be graded (from A to C) and assessed from the degree of cleansing in a 0 - 4 grade scale for each of the predefined colon areas.
2 secondary outcomes
Stool weight as recorded on the case report form for each stool as from start of gut cleansing (day -1) to the beginning of colonoscopy (day 0).
Amount of fluid removed from the colon during the 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 16 Apr 2008.
- Background: PubMed 7380204Davis GR, Santa Ana CA, Morawski SG, Fordtran JS. Development of a lavage solution associated with minimal water and electrolyte absorption or secretion. Gastroenterology. 1980 May;78(5 Pt 1):991-5.
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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.
Alain Bitoun, MD principal investigator
Hopital Lariboisière
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate in people with Colonoscopy, run by Norgine at 1 site in France.
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 12 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 16 Apr 2008. 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 France. 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?
Efficacy measured by a final scoring system i.e., "the overall quality of colonoscopy prep" that will be graded (from A to C) and assessed from the degree of cleansing in a 0 - 4 grade scale for each of the predefined colon areas.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00321230, which also lists 1 linked publication.
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 16 Apr 2008.