Fasitibant Intra-articular Injection in Patients With Symptomatic Osteoarthritis of the Knee

ClinicalTrials.gov ID: NCT02205814

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Official title

A Double-blind, Randomised, Placebo-controlled, Four Parallel Arm, Dose-finding Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Single Intra-articular Injections of Fasitibant in Patients With Symptomatic Osteoarthritis of the Knee.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT02205814
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2
Lead sponsor: Menarini Group; Industry
Enrollment: 436 participants

Conditions and interventions

Conditions

Knee Osteoarthritis

Interventions

Drug

Eligibility (public fields only)

Age range: 40 Years to 80 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Apr 2014 (Type not available)
Primary completion: Jan 2015 (Actual)
Completion: Jan 2015 (Actual)
Last update posted: Nov 3, 2015

2014 – 2015

United States locations

U.S. sites: 9
U.S. states: 8
U.S. cities: 8

Facility	City	State	ZIP	Site status
Tucson Orthopaedic Institute	Tucson	Arizona	85712	—
Colorado Orthopaedic Consultants	Englewood	Colorado	80110	—
Avail Clinical Research, LLC	DeLand	Florida	32720	—
Radiant Research	Columbus	Ohio	43212	—
Columbus Clinical Research	Columbus	Ohio	43213	—
Blair Orthopaedic Associates	Altoona	Pennsylvania	16602	—
Tekton Research	Austin	Texas	78745	—
Physicians Research Options, LLC	Draper	Utah	84020	—
Spokan Joint Replacement Center	Spokane	Washington	99218	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 16 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT02205814, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Nov 3, 2015 · Synced Nov 13, 2026