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Nolpitantium

Phase 2

Ulcerative Colitis | Small molecule | Gastrointestinal |Sanofi|Last Updated: Dec 10, 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment307

FDA Designations

No designations recorded

Clinical trial landscape

Nolpitantium · 1 trial · 2 indications

Phase 2 1
NCT00232258Nolpitantium Besylate In Patients With Ulcerative Colitis a Double-Blind, Placebo Controlled Efficacy and Safety StudyUlcerative Colitis
COMPLETED307 Analytics
PHASE2COMPLETED
Nolpitantium Besylate In Patients With Ulcerative Colitis a Double-Blind, Placebo Controlled Efficacy and Safety Study
Ulcerative ColitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Clinical remission at 8 weeks defined as a clinical Mayo subscore </= 1

Secondary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Nolpitantium besylateDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: * 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 no...

Countries:ArgentinaBelgiumBrazilCanadaChileCzechiaEstoniaHungaryItalyRussiaSingaporeSouth AfricaSpainSweden
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Frequently asked questions about Nolpitantium

What is Nolpitantium used for in Ulcerative Colitis?

Nolpitantium is an investigational small molecule being studied for the treatment of Ulcerative Colitis, a form of Inflammatory Bowel Disease. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities. The drug is being evaluated for its efficacy and safety in patients with this condition.

Who makes Nolpitantium?

Nolpitantium is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol SNY. Sanofi is conducting clinical trials to evaluate the drug's potential as a treatment for Ulcerative Colitis.

What phase is Nolpitantium in?

Nolpitantium is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved for commercial use. The drug is being studied for the treatment of Ulcerative Colitis, and its safety and efficacy are still being evaluated in clinical trials.

What clinical trials is Nolpitantium in?

Nolpitantium has been studied in one completed Phase 2 clinical trial with the identifier NCT00232258. This was a double-blind, placebo-controlled study that enrolled 307 participants with Ulcerative Colitis across multiple countries including Argentina, Belgium, Brazil, Canada, Chile, Czechia, Estonia, Hungary, Italy, Russia, Singapore, South Africa, Spain, and Sweden.

How does Nolpitantium work?

Nolpitantium is a small molecule drug being developed by Sanofi for the treatment of Ulcerative Colitis. Its specific molecular target has not been disclosed in available information. The drug is currently in Phase 2 clinical trials to evaluate its efficacy and safety in patients with this inflammatory bowel condition.