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6MP or Calcitriol vs. Purinethol

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment15

FDA Designations

No designations recorded

6MP or Calcitriol vs. Purinethol clinical trials

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?

6MP or Calcitriol vs. Purinethol refers to a small molecule therapy studied for Crohn's Disease. It is also known as Delayed Release 6MP or Calcitriol vs. Purinethol. The approach compares targeted, local delivery of drugs against Purinethol in a Phase 1 study conducted in Israel.

What is 6MP or Calcitriol vs. Purinethol used for?

6MP or Calcitriol vs. Purinethol was studied for the treatment of Crohn's Disease, a gastrointestinal inflammatory condition. The Phase 1 trial evaluated targeted, local delivery of drugs to treat Crohn's Disease in adult patients aged 18 years and older.

Who makes 6MP or Calcitriol vs. Purinethol?

6MP or Calcitriol vs. Purinethol is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company sponsored the Phase 1 study of this small molecule therapy for Crohn's Disease.

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

6MP or Calcitriol vs. Purinethol is in Phase 1 development. The single Phase 1 trial has been completed, and no active trials are currently listed. It is an investigational therapy and has not been approved for Crohn's Disease.

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

6MP or Calcitriol vs. Purinethol was evaluated in one completed Phase 1 trial, NCT00287170, titled Efficacy Study of Targeted, Local Delivery of Drugs to Treat Crohn's Disease. The trial enrolled 15 adults in Israel, used a randomized design, and was uncontrolled.

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

Yes, 6MP or Calcitriol vs. Purinethol is also known as Delayed Release 6MP or Calcitriol vs. Purinethol. Both names refer to the same small molecule therapy developed by Teva Pharmaceutical Industries Limited for Crohn's Disease.