A Study of the Efficacy and Safety of MEDI7352 in Subjects With Painful Osteoarthritis of the Knee
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Painful Osteoarthritis of the Knee
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This is a Phase IIb, multinational, multicentre, randomised, double-blind, placebo-controlled, dose-response study of MEDI7352 in participants 18 to 80 years of age (inclusive) with moderate-to-severe chronic pain of the knee. The study consists of a screening period of up to 45 days, a 12-week treatment period, and a 20-week follow-up (FU) period. Daily pain scores (as measured on an 11-point numerical rating scale [NRS]) recorded at the first screening visit and from Day -7 to Day -1 will be used be used to determine eligibility. Participants will be randomised to one of 4 doses of MEDI7352 or placebo. Each participant will receive 6 doses of MEDI7352 or placebo during the treatment period. After the end-of-treatment (EOT) visit at Week 12, participants will enter the FU period, which comprises 3 clinic visits (Weeks 18, 28, and 32) and 3 FU phone calls (Weeks 15, 21, and 24). All participants who receive IP are expected to complete the FU period.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: All participants will be centrally assigned to randomised IP using an IRT/RTSM system. Before the study is initiated, the telephone number and call-in directions for the IRT and/or the log in information and directions for the RTSM will be provided to each site. The IRT/RTSM will provide the investigator(s) or appropriate study personnel with the kit identification number to be allocated to the participant at the IP dosing visit. Details for this will be described in the IRT/RTSM user manual that will be provided to each centre. All participants, investigators, and study personnel involved in the conduct of the study will be blinded to treatment assignment. The unblinded study personnel (eg, site pharmacist) will not participate in study procedures or data analysis prior to unblinding of the study data to all study-related personnel. Unblinded AstraZeneca personnel who are not otherwise involved in the study will prepare data for review and interim analyses.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT04675034
- Collaborators
- Not Provided
- Investigators
- Not Provided
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