4 completed, 2 terminated, 1 withdrawn. 6 Phase 1, 5 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 6 | Completed 4, Terminated 2 |
| Phase 2 | 5 | Completed 2, Terminated 2, Withdrawn 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Open Label Extension Study to Protocol C2/13/DR-6MP-02 80 mg DR-6MP - Crohn's Disease | Phase 2 | Withdrawn | Teva GTC | 2011-10-01 | 2013-03-07 | |
| Multicenter Clinical Efficacy and Safety Study of Delayed Release 6MP in Crohn's Disease Delayed Release 6 mercaptopurine, 6 Mercaptopurine - Crohn's Disease | Phase 1 / Phase 2 | Terminated | Teva GTC | 70 | 2010-11-01 | 2013-03-07 |
| Pilot Comparative Bioavailability Study of 6Mercaptopurine (Delayed Release vs. Purinethol) in Crohns Disease Patients Delayed Release 6 mercaptopurine, 6 Mercaptopurine - Crohns Disease | Phase 1 | Completed | Teva GTC | 12 | 2008-12-01 | 2009-07-17 |
| One Year Extension Study To Protocol C2/5/TZ:MS-05 sublingual tizanidine 12 mg - Spasticity, Multiple Sclerosis | Phase 1 / Phase 2 | Terminated | Teva GTC | 10 | 2008-01-01 | 2009-02-19 |
| Study of Nighttime Dosing of Sublingual Tizanidine (12 mg) in Multiple Sclerosis (MS) Patients With Significant Spasticity Tizanidine (sublingual or oral) - Muscle Spasticity | Phase 1 / Phase 2 | Completed | Teva GTC | 20 | 2006-12-01 | 2009-01-21 |
| Pilot, Proof-of-Concept Study of Sublingual Tizanidine in Children With Chronic Traumatic Brain Injury (TBI) Sublingual Tizanidine HCl - Traumatic Brain Injury | Phase 1 | Completed | Teva GTC | 5 | 2006-12-01 | 2009-01-21 |
| Efficacy Study of Targeted, Local Delivery of Drugs to Treat Crohn's Disease Delayed Release 6MP or Calcitriol vs. Purinethol - Crohn's Disease | Phase 1 / Phase 2 | Completed | Teva GTC | 15 | 2006-07-01 | 2008-07-08 |
Crohn Disease (4) · Muscle Spasticity (3) · Multiple Sclerosis (2) · Brain Injuries, Traumatic (1) · Fatigue (1)
Mercaptopurine (2) · Administration, Sublingual (1) · tizanidine (1)
Israel (6)
Yaron Ilan, MD (4) · Arnon Karni, MD (2) · Eran Goldin, MD (1) · Ido Yatsiv, MD (1)