WHO ICTRP trial
This study is planned in multiple centers in India, to determine the safety and…
CTRI/2021/04/033028 · Clinical Trials Registry India (CTRI) · Not Recruiting
Key facts
| Trial ID | CTRI/2021/04/033028 |
|---|---|
| Public title | This study is planned in multiple centers in India, to determine the safety and effectiveness of oral suspension which is a Fixed Dose Combination of sodium alginate 250 mg, sodium bicarbonate 133.5 mg and calcium carbonate 80 mg in the treatment of heartburn and indigestion. |
| Scientific title | A Multicentric, Post marketing Surveillance Study to Evaluate the Safety and Effectiveness of Fixed Dose Combination of Sodium Alginate 250 mg, Sodium Bicarbonate 133.5 mg and Calcium Carbonate 80 mg Oral Suspension in Patients with Heartburn and Indigestion |
| Primary sponsor | Naxpar Pharma Pvt Ltd |
| Registry | Clinical Trials Registry India (CTRI) |
| Recruitment status | Not Recruiting |
| Study type | PMS |
| Phase | Post Marketing Surveillance |
| Countries | India |
| Conditions | Health Condition 1: K318- Other specified diseases of stomach and duodenum |
| Interventions | Intervention1: Digeraft: DigeraftTM contain the fixed dose combination (FDC) of sodium alginate 250 mg, sodium bicarbonate 133.5 mg and calcium carbonate 80 mg per 5 mL oral suspension. Each patient will take sodium alginate oral… |
| Registration date | Apr 22, 2021 |
| Target size | 320 |
| Secondary IDs | SASC4001_ v1.0 dt 05.12.2019, amendment 01 dt 31.12.2020 |
| Registry page | ctri.nic.in |
At a glance
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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: