Ulcerative ColitisPhase 2NCT00808977
A Phase II Study to Explore the Safety and Activity of Dersalazine in Patients With Mild to Moderate Ulcerative Colitis
A Phase 2 study testing Dersalazine sodium and Mesalazine in people with Ulcerative Colitis, run by Palau Pharma S.L.U. at 22 sites in 4 countries.
Trial summary
The purpose of the study is to obtain a first clinical assessment of the safety of dersalazine sodium in ulcerative colitis patients with mild to moderate disease. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Dersalazine sodium and Mesalazine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 22 sitesin 4 countries
- Study dates
- Dec 2008to Jun 2010
- 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
- Age 18 to 65 inclusive
- Male, non-child-bearing female or fertile female with appropriate contraception.
- Mild to moderate confirmed active ulcerative colitis
- Able and willing to give informed consent
Who cannot join
- Colitis of other cause
- Pregnancy, inadequate contraception for fertile female patients
- Liver or kidney disease, unstable cardiovascular disease, coagulation disorder.
- Other significant medical condition that preclude participation at investigator criteria
- Allergy or hypersensitivity to salicylates
- Previous or concomitant treatment for ulcerative colitis interfering with safety or activity assessments
Trial locations and contacts
22 sites in 4 countries.
22 sites in 4 countries
Spain10 sites
Investigational site 2
Badalona
Investigational site 15
Barcelona
Investigational site 3
Barcelona
Investigational site 5
Barcelona
Investigational site 21
Cadiz
Investigational site 6
Córdoba
Investigational site 22
Madrid
Investigational site 14
Sabadell
Investigational site 13
Terrassa
Investigational site 4
Terrassa
Hungary5 sites
Investigational site 12
Budapest
Investigational site 10
Eger
Investigational site 9
Miskolc
Investigational site 8
Székesfehérvár
Investigational site 7
Vác
Slovakia5 sites
Investigational site 18
Košice
Investigational site 20
Košice
Investigational site 16
Malacky
Investigational site 17
Nové Zámky
Investigational site 19
Rožňava
About this study
Official title: A Double-blind, Randomised, Placebo and Mesalazine Controlled Phase II Study to Explore the Safety and Activity of Dersalazine in Patients With Mild to Moderate Active Colitis
The purpose of the study is to obtain a first clinical assessment of the safety of dersalazine sodium in ulcerative colitis patients with mild to moderate disease.
- Conditions
- Ulcerative Colitis
- Being tested
- Dersalazine sodium, Mesalazine, Placebo
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dersalazine sodiumDrug
Dersalazine sodium 2400 mg daily
MesalazineDrug
Mesalazine 2400 mg daily
PlaceboDrug
Placebo matching active and experimental treatments
| Study group | Role | What they receive |
|---|---|---|
| Dersalazine | Experimental | Not described Receives: Drug: Dersalazine sodium |
| Mesalazine | Active comparator | Not described Receives: Drug: Mesalazine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with AEs of severe intensity or AEs leading to treatment withdrawal
Measured: 7, 14, 21, 28, 56 days
Secondary outcomes (1)
Mayo index
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Palau Pharma S.L.U.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Julian Panés, MD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00808977
- Sponsor's protocol ID
- CR-IBD-1-08
- Other IDs
- EudraCT 2008-004610-27
- Status last verified
- Nov 2010
- First submitted
- 15 Dec 2008
- Last updated
- 17 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Pontes C, Vives R, Torres F, Panes J. Safety and activity of dersalazine sodium in patients with mild-to-moderate active colitis: double-blind randomized proof of concept study. Inflamm Bowel Dis. 2014 Nov;20(11):2004-12. doi: 10.1097/MIB.0000000000000166.
PubMed 25192498Roman J, Planell N, Lozano JJ, Aceituno M, Esteller M, Pontes C, Balsa D, Merlos M, Panes J, Salas A. Evaluation of responsive gene expression as a sensitive and specific biomarker in patients with ulcerative colitis. Inflamm Bowel Dis. 2013 Feb;19(2):221-9. doi: 10.1002/ibd.23020.
PubMed 22605655
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomised, Placebo and Mesalazine Controlled Phase II Study to Explore the Safety and Activity of Dersalazine in Patients With Mild to Moderate Active Colitis
- ClinicalTrials.gov ID
- NCT00808977
- Acronym / sponsor ID
- CR-IBD-1-08
- Conditions
- Ulcerative Colitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Palau Pharma S.L.U.Industry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 16 Dec 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 the study is to obtain a first clinical assessment of the safety of dersalazine sodium in ulcerative colitis patients with mild to moderate disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dersalazine | Experimental | Drug: Dersalazine sodium |
| Mesalazine | Active comparator | Drug: Mesalazine |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 to 65 inclusive
- Male, non-child-bearing female or fertile female with appropriate contraception.
- Mild to moderate confirmed active ulcerative colitis
- Able and willing to give informed consent
Key exclusion criteria (6 listed)
- Colitis of other cause
- Pregnancy, inadequate contraception for fertile female patients
- Liver or kidney disease, unstable cardiovascular disease, coagulation disorder.
- Other significant medical condition that preclude participation at investigator criteria
- Allergy or hypersensitivity to salicylates
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 |
|---|---|---|
| Dersalazine sodiumDersalazine sodium 2400 mg daily | Drug | Dersalazine |
| MesalazineMesalazine 2400 mg daily | Drug | Mesalazine |
| PlaceboPlacebo matching active and experimental treatments | Drug | Placebo |
Primary outcome
Proportion of patients with AEs of severe intensity or AEs leading to treatment withdrawal
Time frame: 7, 14, 21, 28, 56 days
1 secondary outcome
Mayo index
Time frame: 28 days
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 17 Nov 2010.
- Derived from this study: PubMed 25192498Pontes C, Vives R, Torres F, Panes J. Safety and activity of dersalazine sodium in patients with mild-to-moderate active colitis: double-blind randomized proof of concept study. Inflamm Bowel Dis. 2014 Nov;20(11):2004-12. doi: 10.1097/MIB.0000000000000166.
- Derived from this study: PubMed 22605655Roman J, Planell N, Lozano JJ, Aceituno M, Esteller M, Pontes C, Balsa D, Merlos M, Panes J, Salas A. Evaluation of responsive gene expression as a sensitive and specific biomarker in patients with ulcerative colitis. Inflamm Bowel Dis. 2013 Feb;19(2):221-9. doi: 10.1002/ibd.23020.
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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.
Julian Panés, MD principal investigator
Hospital Clinic of Barcelona
22 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dersalazine sodium and Mesalazine in people with Ulcerative Colitis, run by Palau Pharma S.L.U. at 22 sites in 4 countries.
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 6 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 17 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Spain, Hungary, Slovakia, Belgium. 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. 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?
Proportion of patients with AEs of severe intensity or AEs leading to treatment withdrawal (time frame: 7, 14, 21, 28, 56 days). 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 NCT00808977, which also lists 2 linked publications.
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 17 Nov 2010.