Trials / Completed
CompletedNCT01435577
Intravenous Tapentadol in Post-Bunionectomy Pain
A Randomized, Double-blind, Placebo-controlled Parallel Group, Multicenter Trial to Evaluate the Efficacy and Safety of Multiple Dose Administration of an Intravenous Formulation of Tapentadol in the Treatment of Acute Pain Following Bunionectomy.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 177 (actual)
- Sponsor
- Grünenthal GmbH · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this trial is to established the safety and efficacy of multiple dose treatment with tapentadol IV in an adult population with moderate to severe pain following bunionectomy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tapentadol | 30 mg per administration, maximum 12 administrations over 48 hours |
| DRUG | Matching Placebo | Maximum 12 administrations over 48 hours |
Timeline
- Start date
- 2011-09-01
- Primary completion
- 2012-02-01
- Completion
- 2012-02-01
- First posted
- 2011-09-16
- Last updated
- 2019-10-28
- Results posted
- 2013-06-24
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01435577. Inclusion in this directory is not an endorsement.