Trials / Terminated
TerminatedNCT04355169
A Study of Naldemedine in Participants Undergoing Surgeries That Include a Bowel Resection or Bowel Transection
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Naldemedine in Patients Undergoing Surgeries That Include a Bowel Resection or Bowel Transection
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 2 (actual)
- Sponsor
- Shionogi · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to compare the efficacy of naldemedine versus placebo and to assess its effect on the time to gastrointestinal (GI) recovery following surgeries that include bowel resection and bowel transection.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Naldemedine | Oral tablet |
| DRUG | Placebo | Oral tablet |
Timeline
- Start date
- 2020-11-06
- Primary completion
- 2021-01-04
- Completion
- 2021-01-04
- First posted
- 2020-04-21
- Last updated
- 2022-01-18
- Results posted
- 2022-01-18
Locations
8 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04355169. Inclusion in this directory is not an endorsement.