Ulcerative ColitisPhase 2NCT00867438
Efficacy and Tolerability of a New Oral Extended-Release Formulation Containing Parnaparin Sodium, Administered Add-on Therapy
A Phase 2 study testing Sigmoidoscopy in people with Ulcerative Colitis, run by Cosmo Technologies Ltd.
Trial summary
The objective of this study is to evaluate the efficacy and the tolerability of oral parnaparin sodium (210mg), administered in extended-release tablets identified as CB-01-05-MMX™. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Sigmoidoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 133 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Nov 2007
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients, between 18 and 70 years of age.
- Patients with a confirmed diagnosis of ulcerative colitis in treatment with fixed-dose of oral mesalazine or other 5-ASA derivatives for at least 4 weeks with a high clinical suspicion of active disease, confirmed by sigmoidoscopy at enrolment in the study .
- Presence of ulcerative colitis located at left side of the colon, from splenic flexure of the colon to the rectum (up to 15 cm proximal to the anus).
- Patients with mild to moderate active ulcerative colitis, as defined by the DAI ≥ 4 and ≤ 10, and CAI ≥ 5 and ≤ 12.
- Women with negative serum test for pregnancy.
- Women of childbearing potential provided they use adequate contraceptive precautions during the treatment period. Adequate contraceptive methods are defined as those with a failure rate <1% per year when correctly used, and include implants, injectables, combined oral pills, some IUDs or a vasectomised partner in a stable relationship.
- Ability to understand and willing to sign the Informed Consent Form, and other documents required to be read or signed by the subject.
Who cannot join
- Presence of other clinically significant medical condition as determined by the Investigator.
- History of hypersensitivity or idiosyncratic reaction to heparins.
- History of hemorrhages, excluding intestinal bleeding due to ulcerative colitis, hemocoagulative disorders, or platelet dysfunction.
- Presence of arterial hypertension (SAP ≥ 160 mm Hg; DAP ≥ 95 mm Hg).
- Receipt of any investigational agent within 90 days of starting treatment.
- Use of rectal 5-ASAs or rectal corticosteroids within 2 weeks before the starting the study.
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- Use of anti-TNF agents or immunosuppressive drugs such as azothioprine, 6-mercaptopurine or cyclosporine A in the last 3 months.
- Patients with ulcerative colitis of severe entity (DAI > 10 or CAI > 12), or with limited distal ulcerative proctitis, or with infectious colitis confirmed by microbiological assessment in stool.
- Patients with severe intestinal bleeding, or with Hb < 9 g/dL.
- Presence of significant hepatic impairment (AST, ALT > 2 ULN).
- Presence of significant renal impairment (creatinine > 2 ULN).
- Women who are pregnant or who are breast feeding.
- Intestinal obstruction.
- Presence of type 1 or type 2 diabetes.
- Concomitant oral antibiotic treatment, within 2 weeks before starting the study.
About this study
Official title: Efficacy and Tolerability of a New Oral Extended-Release Formulation Containing Parnaparin Sodium (CB-01-05-MMX™), Administered as Add-on Therapy to Oral Mesalazine or Other 5-ASA Derivatives, in Patients With Active, Left-Sided, Mild to Moderate Ulcerative Colitis. A Multicentre Randomized, Double-Blind, Comparative Study Versus Placebo.
The objective of this study is to evaluate the efficacy and the tolerability of oral parnaparin sodium (210mg), administered in extended-release tablets identified as CB-01-05-MMX™.
- Conditions
- Ulcerative Colitis
- Being tested
- Sigmoidoscopy
- Keywords
- ulcerative colitis, Left-sided, mild to moderate ulcerative colitis
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SigmoidoscopyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Procedure: Sigmoidoscopy |
| 2 | Experimental | Not described Receives: Procedure: Sigmoidoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients achieving clinical remission (CAI <4).
Measured: 8 weeks
Secondary outcomes (1)
Endoscopic Index, Histologic Score of mucosal bioptic specimens, AEs, laboratory parameters, vital signs.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2009 (estimated)
- Study startJan 2007
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cosmo Technologies Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Antonio Gasbarrini, Prof, Principal investigator, Department of Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00867438
- Sponsor's protocol ID
- CB-01-05/04
- Status last verified
- Mar 2009
- First submitted
- 20 Mar 2009
- Last updated
- 25 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerability of a New Oral Extended-Release Formulation Containing Parnaparin Sodium (CB-01-05-MMX™), Administered as Add-on Therapy to Oral Mesalazine or Other 5-ASA Derivatives, in Patients With Active, Left-Sided, Mild to Moderate Ulcerative Colitis. A Multicentre Randomized, Double-Blind, Comparative Study Versus Placebo.
- ClinicalTrials.gov ID
- NCT00867438
- Acronym / sponsor ID
- CB-01-05/04
- Conditions
- Ulcerative Colitis
- Keywords
- ulcerative colitis, Left-sided, mild to moderate ulcerative colitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Cosmo Technologies LtdIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 23 Mar 2009 (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 objective of this study is to evaluate the efficacy and the tolerability of oral parnaparin sodium (210mg), administered in extended-release tablets identified as CB-01-05-MMX™.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Procedure: Sigmoidoscopy |
| 2 | Experimental | Procedure: Sigmoidoscopy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female patients, between 18 and 70 years of age.
- Patients with a confirmed diagnosis of ulcerative colitis in treatment with fixed-dose of oral mesalazine or other 5-ASA derivatives for at least 4 weeks with a high clinical suspicion of active disease, confirmed by sigmoidoscopy at enrolment in the study .
- Presence of ulcerative colitis located at left side of the colon, from splenic flexure of the colon to the rectum (up to 15 cm proximal to the anus).
- Patients with mild to moderate active ulcerative colitis, as defined by the DAI ≥ 4 and ≤ 10, and CAI ≥ 5 and ≤ 12.
- Women with negative serum test for pregnancy.
Key exclusion criteria (15 listed)
- Presence of other clinically significant medical condition as determined by the Investigator.
- History of hypersensitivity or idiosyncratic reaction to heparins.
- History of hemorrhages, excluding intestinal bleeding due to ulcerative colitis, hemocoagulative disorders, or platelet dysfunction.
- Presence of arterial hypertension (SAP ≥ 160 mm Hg; DAP ≥ 95 mm Hg).
- Receipt of any investigational agent within 90 days of starting treatment.
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 |
|---|---|---|
| Sigmoidoscopy | Procedure or surgery | 1, 2 |
Primary outcome
The number of patients achieving clinical remission (CAI <4).
Time frame: 8 weeks
1 secondary outcome
Endoscopic Index, Histologic Score of mucosal bioptic specimens, AEs, laboratory parameters, vital signs.
Time frame: 8 weeks
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 25 Mar 2009.
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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.
Antonio Gasbarrini, Prof principal investigator
Department of Internal Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sigmoidoscopy in people with Ulcerative Colitis, run by Cosmo Technologies Ltd.
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 7 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 25 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The number of patients achieving clinical remission (CAI <4). (time frame: 8 weeks). 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 2009.