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6MP or Calcitriol vs. Purinethol

Phase 1

Crohn's Disease | Small molecule | Gastrointestinal |Teva Pharmaceutical Industries Limited|Last Updated: Jul 8, 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment15

FDA Designations

No designations recorded

Clinical trial landscape

6MP or Calcitriol vs. Purinethol · 1 trial · 1 indication

Phase 1 1
NCT00287170Efficacy Study of Targeted, Local Delivery of Drugs to Treat Crohn's DiseaseCrohn's Disease
COMPLETED15 Analytics
PHASE1COMPLETED
Efficacy Study of Targeted, Local Delivery of Drugs to Treat Crohn's Disease
Crohn's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Remission-defined as a CDAI (Crohn's Disease Activity Index) of <150
12 weeks
Response- defined as a fall in the CDAI by 100 points or more from baseline
12 weeks

Secondary Endpoints

Improvement in ESR (Erythrocyte Sedimentation Rate), CRP (C-Reactive Protein) levels, and IBDQ (Inflammatory Bowel Disease Questionnaire) >=180 indicative of remission
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Delayed Release 6MP or Calcitriol vs. PurinetholDRUG -
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male or Female patients, aged 18-75 years with moderate Crohn's Disease (CDAI score \>=220 and \<=400 at screening), with or without adjunctive mesalamine treatment, 12 with involvement of the ileum and three without ileal involvement * Definitive diagnosis of active inflammat...

Countries:Israel
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Frequently asked questions about 6MP or Calcitriol vs. Purinethol

What is 6MP or Calcitriol vs. Purinethol used for in Crohn's Disease?

6MP or Calcitriol vs. Purinethol is an investigational small molecule being studied for the treatment of Crohn's Disease. It is being evaluated in a Phase 1 clinical trial that has been completed. The drug is intended for patients with Crohn's Disease, a type of inflammatory bowel disease.

What does 6MP or Calcitriol vs. Purinethol target?

The specific molecular target of 6MP or Calcitriol vs. Purinethol is not disclosed in the available information. The drug is being studied for its efficacy in treating Crohn's Disease, but the exact mechanism of action has not been specified in the clinical trial data.

Who makes 6MP or Calcitriol vs. Purinethol?

6MP or Calcitriol vs. Purinethol is being developed by Teva Pharmaceutical Industries Limited, a company traded on the stock exchange under the ticker symbol TEVA. The drug is currently in clinical development for Crohn's Disease.

What phase is 6MP or Calcitriol vs. Purinethol in?

6MP or Calcitriol vs. Purinethol is in Phase 1 clinical development. The Phase 1 trial has been completed, and the drug remains investigational. It has not been approved by regulatory authorities and is still undergoing clinical evaluation for Crohn's Disease.

What clinical trials is 6MP or Calcitriol vs. Purinethol in?

6MP or Calcitriol vs. Purinethol has been studied in one clinical trial with the identifier NCT00287170. This Phase 1 trial, titled 'Efficacy Study of Targeted, Local Delivery of Drugs to Treat Crohn's Disease,' was completed in Israel and enrolled 15 participants aged 18 years and older.

Is 6MP or Calcitriol vs. Purinethol the same as Purinethol?

6MP or Calcitriol vs. Purinethol is a drug being studied in comparison with Purinethol, but it is not the same drug. The name indicates a study comparing 6MP or Calcitriol against Purinethol. The drug is being developed by Teva Pharmaceutical Industries Limited for Crohn's Disease.