Trials / Completed
CompletedNCT01684202
A Multicenter, Open-label, Dose-finding Trial of OPC-41061 to Investigate Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety in Patients With Carcinomatous Edema (Phase 2)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 43 (actual)
- Sponsor
- Otsuka Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
OPC-41061 will be administered to patients with volume overload associated with cancer, first by dose-escalation and subsequently for 6 consecutive days at the fixed dose at which urine volume is increased to investigate efficacy, pharmacokinetics, pharmacodynamic effects, and safety and to determine the effective initial and maintenance doses of OPC-41061.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | OPC-41061 | orally administered at 3.75, 7.5, 15, or 30 mg once daily after breakfast for up to 11 days. |
Timeline
- Start date
- 2012-07-01
- Primary completion
- 2013-12-01
- Completion
- 2014-06-01
- First posted
- 2012-09-12
- Last updated
- 2021-03-18
- Results posted
- 2021-03-18
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT01684202. Inclusion in this directory is not an endorsement.