WHO ICTRP trial
A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s…
EUCTR2015-001925-18-GB · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2015-001925-18-GB |
|---|---|
| Public title | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease |
| Scientific title | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety o |
| Primary sponsor | Celgene Corporation |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic… |
| Conditions | Active Crohn's disease MedDRA version: 20.0 Level: LLT Classification code 10021315 Term: Ileitis terminal System Organ Class: 100000016693 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] |
| Interventions | Product Name: Mongersen Product Code: GED-0301 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: mongersen CAS Number: 1443994-98-6 Current Sponsor code: GED-0301 Concentration unit: mg milligram(s) Concentration type: equal… |
| Registration date | Nov 18, 2015 |
| Target size | 1064 |
| Secondary IDs | GED-0301-CD-002 |
| Registry page | clinicaltrialsregister.eu |
At a glance
- Yes Results available
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About WHO ICTRP trial registrations
The WHO ICTRP combines trial registrations from primary registries worldwide into a single searchable index. Contact and ethics-committee details are not shown here.
Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: