Trials / Terminated
TerminatedNCT02865122
Safety and Efficacy Study in Infant With SBS
A Multi-Center, Randomized, Double-Blind, Three-Arm, Parallel-Group Trial to Assess the Efficacy and Safety of NTRA-9620 in Infants With Short Bowel Syndrome (SBS) Following Surgical Resection
- Status
- Terminated
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 2 (actual)
- Sponsor
- Elgan Pharma Ltd. · Industry
- Sex
- All
- Age
- 2 Weeks – 52 Weeks
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NTRA-9620 | Oral daily dose |
| DRUG | Placebo | Oral daily dose |
Timeline
- Start date
- 2017-03-20
- Primary completion
- 2018-03-22
- Completion
- 2018-03-22
- First posted
- 2016-08-12
- Last updated
- 2021-10-12
- Results posted
- 2021-10-12
Locations
8 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02865122. Inclusion in this directory is not an endorsement.