WHO ICTRP trial
A clinical study to investigate the effect of fixed dose combination of…
CTRI/2020/12/029792 · Clinical Trials Registry India (CTRI) · Not Recruiting
Key facts
| Trial ID | CTRI/2020/12/029792 |
|---|---|
| Public title | A clinical study to investigate the effect of fixed dose combination of Pregabalin plus Mecobalamin plus Nortriptyline Tablets for the treatment of diabetic peripheral neuropathic pain with coexistent Vitamin B12 deficiency in adult patients. |
| Scientific title | â??A Multicentric, Randomized, Double Blind, Parallel Group, Comparative, Phase III Clinical Study to Evaluate the Efficacy, Safety and Tolerability of FDC of Pregabalin SR 75 mg plus Mecobalamin 1500 mcg plus Nortriptyline 10 mg Tablets Versus FDC of Pregabalin SR 75 mg plus Methylcobalamin 1500… |
| Primary sponsor | Synokem Pharmaceuticals Ltd |
| Registry | Clinical Trials Registry India (CTRI) |
| Recruitment status | Not Recruiting |
| Study type | Interventional |
| Phase | Phase 3 |
| Countries | India |
| Conditions | Health Condition 1: G629- Polyneuropathy, unspecified |
| Interventions | Intervention1: FDC of Pregabalin SR 75 mg plus Mecobalamin 1500 mcg plus Nortriptyline 10 mg Tablets: One tablet once a day orally every night at bedtime for 12 weeks Control Intervention1: FDC of Pregabalin SR 75 mg plus Methylcobalamin… |
| Registration date | Dec 15, 2020 |
| Target size | 200 |
| Secondary IDs | CRPL/CT/19/014;Version No. 01, Dated Jul 06, 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: