drugset / Trial / NCT01258153
Preliminary Efficacy and Safety Study of Oral Nepadutant in Infant Colic
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This phase IIa study is designed as a multi-centre, multinational, randomised, double-blind, placebo controlled study in three parallel groups, with the aim to evaluate the efficacy and safety of Nepadutant given at two oral doses once daily for seven days in comparison to placebo in the treatment of infantile colic.
Timeline
- Start
- 2010-11
- Primary completion
- 2013-12
- Completion
- 2014-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nepadutant | Protein / enzyme biologic | — | Oral |
Indications
No indication recorded.