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NCT02205814 · ClinicalTrials.gov registry record · Phase 2
Fasitibant Intra-articular Injection in Patients With Symptomatic Osteoarthritis of the Knee
A Phase 2 study, sponsored by Menarini Group.
- Completed
- Registry status
- Phase 2
- Development phase
- 436
- Enrollment target
NCT02205814 is a Phase 2 study that has completed, run by Menarini Group. The registered enrollment target is 436 participants.
The verdict
NCT02205814, a Phase 2 study, has completed, sponsored by Menarini Group.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 436 participants
- Enrollment target
Study Summary
This study is designed as a double-blind, randomised, placebo-controlled, four parallel arm, dose-finding study, to be conducted in approximately 26 sites, to evaluate the efficacy, safety, tolerability, and pharmacokinetics of single intra-articular (IA) injections of fasitibant in patients with symptomatic osteoarthritis (OA) of the knee. Approximately 400 male and female patients 40-80 years old, with BMI \< 30 kg/m² and with a clinical diagnosis of symptomatic primary osteoarthritis of the knee will be randomised to a total of 4 treatment arms. Each arm includes a single intra-articular injection of one of three dosages of fasitibant (low, intermediate and high dose) OR placebo. The randomisation ratio will be 1:1:1:1. The primary efficacy variable will be the change of the Western Ontario and McMaster Universities Visual Analogue Scale 3.1 A (WOMAC VA 3.1 A) (total pain) subscore from baseline up to 2 weeks after randomisation. Safety will be assessed by monitoring adverse events and clinical laboratory tests; local tolerability at the injection site will also be assessed. In addition, the population pharmacokinetics and the exposure-response relationship will be evaluated. The individual experimental clinical phase will last up to maximal 15 weeks encompassing 7 planned visits at site, including screening, randomisation, 4 follow-up visits and the End of study visit.
Interventions
- DRUG Placebo comparator
- DRUG Fasitibant- low dose
- DRUG Fasitibant- intermediate dose
- DRUG Fasitibant- high dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 436 participants |
| Start Date | 2014-04 |
| Est. Completion | 2015-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02205814
The ClinicalTrials.gov registry entry for NCT02205814 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 436 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Menarini Group, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo comparator is the first listed.
NCT02205814 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02205814 about?
NCT02205814 is a clinical study titled "Fasitibant Intra-articular Injection in Patients With Symptomatic Osteoarthritis of the Knee". This study is designed as a double-blind, randomised, placebo-controlled, four parallel arm, dose-finding study, to be conducted in approximately 26 sites, to evaluate the efficacy, safety, tolerability, and pharmacokinetics of single intra-articular (IA) injections of fasitibant in patients with sy...
What is the current status of trial NCT02205814?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 436 participants. The study started on 2014-04. Estimated completion is 2015-01.
What interventions are being tested in trial NCT02205814?
The interventions under investigation include: Placebo comparator (DRUG), Fasitibant- low dose (DRUG), Fasitibant- intermediate dose (DRUG), Fasitibant- high dose (DRUG).
Who is sponsoring clinical trial NCT02205814?
This trial is sponsored by Menarini Group, which has 9 total clinical trials registered on ClinicalTrials.gov.
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