Dose Finding Study of STR-324
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Pain Acute
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Step 1 of the study is single blinded for participants only.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 64 years
- Gender
- Both males and females
Description
The first step (single-blind standard group) aims to verify the sensitivity of the study pain model in the proposed surgery to confirm the validity of the surgery according to their pain and enrolment rate. 12 patients are planned to be enrolled. The second step (dose-finding study) is a randomized,...
The first step (single-blind standard group) aims to verify the sensitivity of the study pain model in the proposed surgery to confirm the validity of the surgery according to their pain and enrolment rate. 12 patients are planned to be enrolled. The second step (dose-finding study) is a randomized, double-blind, parallel groups, placebo-controlled clinical trial involving a total of 104 patients divided into two groups in which patients will be randomized between STR-324 and placebo: Group 1: Titration initiated with a bolus Group 2: Titration without initial bolus.
Tracking Information
- NCT #
- NCT04582786
- Collaborators
- Not Provided
- Investigators
- Not Provided
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