# Preliminary Efficacy and Safety Study of Oral Nepadutant in Infant Colic

> **NCT01258153** · PHASE2 · COMPLETED · sponsor: **Menarini Group** · enrollment: 115 (actual)

## Conditions studied

- Infantile Colic

## Interventions

- **DRUG:** Nepadutant oral solution
- **DRUG:** Nepadutant oral solution
- **DRUG:** Placebo matching Nepadutant oral solution

## Key facts

- **NCT ID:** NCT01258153
- **Lead sponsor:** Menarini Group
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2010-11
- **Primary completion:** 2013-12
- **Final completion:** 2014-03
- **Target enrollment:** 115 (ACTUAL)
- **Last updated:** 2015-06-10


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01258153

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01258153, "Preliminary Efficacy and Safety Study of Oral Nepadutant in Infant Colic". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT01258153. Licensed CC0.

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