WHO ICTRP trial
A study of tacrolimus suspension of Intas Pharmaceuticals Limited, India against…
CTRI/2019/04/018626 · Clinical Trials Registry India (CTRI) · Not Recruiting
Key facts
| Trial ID | CTRI/2019/04/018626 |
|---|---|
| Public title | A study of tacrolimus suspension of Intas Pharmaceuticals Limited, India against CORTENEMA® of Anip Acquisition Company, USA in adult patients with inflammation in the digestive tract. |
| Scientific title | A randomized, multi-centre, open label, two-arm, parallel, clinical study to evaluate the efficacy, safety and tolerability of tacrolimus lipid suspension for enema of Intas Pharmaceuticals Limited, India against CORTENEMA® (Hydrocortisone retention enema) of Anip Acquisition Company, USA in adult… |
| Primary sponsor | Intas Pharmaceuticals Limited |
| Registry | Clinical Trials Registry India (CTRI) |
| Recruitment status | Not Recruiting |
| Study type | Interventional |
| Phase | Phase 3 |
| Countries | India |
| Conditions | Health Condition 1: K515- Left sided colitis |
| Interventions | Intervention1: Tacrolimus lipid suspension for enema 4 mg/vial of Intas Pharmaceuticals Limited, India: Dose: 4 mg; Frequency: Daily before sleeping at night ; Mode of Administration: Per rectal administration; Duration of treatment: 4… |
| Registration date | Apr 15, 2019 |
| Target size | 303 |
| Secondary IDs | 0979-17, Version no. 2.0, Date: 28 Sep 2018 |
| Registry page | ctri.nic.in |
At a glance
- No Results available
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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: