Ulcerative ColitisPhase 2NICENCT00232258
Nolpitantium Besylate In Patients With Ulcerative Colitis a Double-Blind, Placebo Controlled Efficacy and Safety Study
A Phase 2 study testing Nolpitantium besylate in people with Ulcerative Colitis and Inflammatory Bowel Disease, run by Sanofi at 14 sites in 14 countries.
Trial summary
To evaluate the safety and efficacy on clinical symptoms, mucosal histology and endoscopic mucosal appearance of two doses of SR140333B against placebo in patients with mild to moderate ulcerative colitis resistant to treatment with 5-ASA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis, Inflammatory Bowel Disease
- What is being tested?
- Nolpitantium besylate
- How many people
- 307 participants
- Where
- 14 sitesin 14 countries
- Study dates
- Apr 2005to Sep 2006
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age at least 18 years
- Ulcerative colitis of at least 6 months duration
- Patient's ulcerative colitis should remain active while taking 5-ASA or sulfasalazine for at least 4 week
- If taking corticosteroids, dose must be stable for at least 2 weeks prior to enrollment and not exceed 20 mg per day (prednisolone equivalent)
Who cannot join
- Crohn's disease
- Colonic dysplasia
- Stool culture positive for enteric pathogens
- Concurrent cancer or unstable medical condition
- Recent treatment with monoclonal antibody
- Recent introduction of thiazolidinedione
- Recent treatment with methotrexate or cyclosporine
- Recent treatment with an antibiotic prescribed for ulcerative colitis
Trial locations and contacts
14 sites in 14 countries.
14 sites in 14 countries
About this study
Official title: Nolpitantium Besylate in Patients With Mild to Moderate Ulcerative Colitis, a Double-Blind, Placebo Controlled Efficacy and Safety, 8 Week Study
To evaluate the safety and efficacy on clinical symptoms, mucosal histology and endoscopic mucosal appearance of two doses of SR140333B against placebo in patients with mild to moderate ulcerative colitis resistant to treatment with 5-ASA.
Read the detailed description
Patients with active mild to moderate ulcerative colitis that has not responded to a minimum of 4 weeks of 5-ASA will be randomized to receive single daily doses of either placebo, 600 mg SR140333B or 1800 mg of SR140333B for eight weeks. Patients will undergo baseline and end of study sigmoidoscopic assessments and complete daily symptom diaries during the study. Ulcerative colitis disease activity will be measured by both the overall and component subscores of the Mayo Disease Activity Index.
- Conditions
- Ulcerative Colitis, Inflammatory Bowel Disease
- Being tested
- Nolpitantium besylate
- Keywords
- NK1 Antagonist, Inflammatory Bowel Disease, Mesalamine
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nolpitantium besylateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical remission at 8 weeks defined as a clinical Mayo subscore </= 1
Secondary outcomes (4)
Clinical response defined as at least 3 point reduction from baseline on Clinical Mayo Sub-score
Global change in overall Disease Activity Index
Abdominal pain score at 8 weeks
Safety profile
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2005 (estimated)
- Study startApr 2005
- Primary completionSep 2006
- Study completionSep 2006
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.
- More trials run by SanofiThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 307 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gert Van Assche, MD, Principal investigator, Universitaire Ziekenhizen Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00232258
- Sponsor's protocol ID
- DRI4553
- Acronym
- NICE
- Status last verified
- Dec 2008
- First submitted
- 3 Oct 2005
- Last updated
- 10 Dec 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nolpitantium Besylate in Patients With Mild to Moderate Ulcerative Colitis, a Double-Blind, Placebo Controlled Efficacy and Safety, 8 Week Study
- ClinicalTrials.gov ID
- NCT00232258
- Acronym / sponsor ID
- NICE / DRI4553
- Conditions
- Ulcerative Colitis, Inflammatory Bowel Disease
- Keywords
- NK1 Antagonist, Inflammatory Bowel Disease, Mesalamine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 4 Oct 2005 (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.
To evaluate the safety and efficacy on clinical symptoms, mucosal histology and endoscopic mucosal appearance of two doses of SR140333B against placebo in patients with mild to moderate ulcerative colitis resistant to treatment with 5-ASA.
Detailed description
Patients with active mild to moderate ulcerative colitis that has not responded to a minimum of 4 weeks of 5-ASA will be randomized to receive single daily doses of either placebo, 600 mg SR140333B or 1800 mg of SR140333B for eight weeks. Patients will undergo baseline and end of study sigmoidoscopic assessments and complete daily symptom diaries during the study. Ulcerative colitis disease activity will be measured by both the overall and component subscores of the Mayo Disease Activity Index.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age at least 18 years
- Ulcerative colitis of at least 6 months duration
- Patient's ulcerative colitis should remain active while taking 5-ASA or sulfasalazine for at least 4 week
- If taking corticosteroids, dose must be stable for at least 2 weeks prior to enrollment and not exceed 20 mg per day (prednisolone equivalent)
Key exclusion criteria (8 listed)
- Crohn's disease
- Colonic dysplasia
- Stool culture positive for enteric pathogens
- Concurrent cancer or unstable medical condition
- Recent treatment with monoclonal antibody
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 |
|---|---|---|
| Nolpitantium besylate | Drug | – |
Primary outcome
Clinical remission at 8 weeks defined as a clinical Mayo subscore </= 1
4 secondary outcomes
Clinical response defined as at least 3 point reduction from baseline on Clinical Mayo Sub-score
Global change in overall Disease Activity Index
Abdominal pain score at 8 weeks
Safety profile
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 Dec 2008.
- Related InfoLink provided by the sponsor.
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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.
Gert Van Assche, MD principal investigator
Universitaire Ziekenhizen Leuven
14 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nolpitantium besylate in people with Ulcerative Colitis and Inflammatory Bowel Disease, run by Sanofi at 14 sites in 14 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 8 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 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Argentina, Belgium, Brazil, Canada, Chile and 9 more countries. 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?
Clinical remission at 8 weeks defined as a clinical Mayo subscore </= 1. 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 Dec 2008.