MedTrace Logo

Safety and Efficacy Study in Infant With SBS

NCT02865122 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2021-10-12

Study results available
· View outcomes & findings →

Summary

The objective of this clinical study is to evaluate the efficacy and safety of NTRA-9620 compared with placebo in pediatric subjects (aged 28 weeks postmenstrual age to 52 weeks old) with SBS following surgical resection

Conditions

  • Short Bowel Syndrome

Interventions

DRUG

NTRA-9620

Oral daily dose

DRUG

Placebo

Oral daily dose

Sponsors & Collaborators

  • Elgan Pharma Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Weeks
Max Age
52 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-20
Primary Completion
2018-03-22
Completion
2018-03-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02865122 on ClinicalTrials.gov