WHO ICTRP trial
13-WEEK STUDY FOR EVALUATION OF EFFICACY AND SAFETY OF IN-AQUL-002 TABLET…
CTRI/2010/091/006085 · Clinical Trials Registry India (CTRI) · Not Recruiting
Key facts
| Trial ID | CTRI/2010/091/006085 |
|---|---|
| Public title | 13-WEEK STUDY FOR EVALUATION OF EFFICACY AND SAFETY OF IN-AQUL-002 TABLET COMPARED TO OXCARBAZEPINE SUSTAINED-RELEASE TABLET AS ADJUNCTIVE TREATEMENT IN ADULT PATIENTS WITH REFRACTORY PARTIAL-ONSET SEIZURES |
| Scientific title | AN OPEN LABEL, RANDOMIZED, PARALLEL GROUP, PROSPECTIVE, MULTICENTRE CLINICAL TRIAL FOR EVALUATION OF EFFICACY AND SAFETY OF IN-AQUL-002 IN COMPARISON WITH OXCARBAZEPINE SUSTAINED-RELEASE AS ADJUNCTIVE TREATEMENT IN ADULT PATIENTS WITH REFRACTORY PARTIAL-ONSET SEIZURES |
| 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: null- REFRACTORY PARTIAL-ONSET SEIZURES |
| Interventions | Intervention1: IN-AQUL-002: Start study medication as one tablet once daily. At first follow-up if medication is well tolerated then escalate the dose to two tablets once daily. In case need for further titration, dose can be increased to… |
| Registration date | Dec 22, 2010 |
| Target size | 270 |
| Secondary IDs | CT/IN-AQUL-002/EPI/III/10 |
| Registry page | ctri.nic.in |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: