Safety and Effectiveness Study of a Non-Crosslinked HA Alkylamide HYADD(TM) 4 Hydrogel for Osteoarthritis of the Knee
Sponsor
Fidia Farmaceutici s.p.a. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT02187549
Collaborator
(none)
332
21
2
21
15.8
0.8
Study Details
Study Description
Brief Summary
The purpose of this study is to determine whether intra-articular hyaluronic acid provides symptomatic relief of osteoarthritis of the knee.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
332 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Study Start Date
:
Jun 1, 2014
Anticipated Primary Completion Date
:
Feb 1, 2016
Anticipated Study Completion Date
:
Mar 1, 2016
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: HYMOVIS HYADD(TM) 4 Hydrogel Intra-Articular Injection |
Device: HYMOVIS
Intra-articular injection
Other Names:
|
Placebo Comparator: Placebo Saline Intra-Articular Injection |
Device: Placebo
Intra-Articular Injection
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Sub-score [26 weeks]
Secondary Outcome Measures
- Patient Global Assessment [26 weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
40 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Symptomatic osteoarthritis of the knee.
Exclusion Criteria:
- No disorders which could interfere with study required assessments.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Achieve Clinical Research | Birmingham | Alabama | United States | 35216 |
2 | Alabama Clinical Therapeutics | Brimingham | Alabama | United States | 35235 |
3 | Elite Clinical Studies | Phoenix | Arizona | United States | 85018 |
4 | Arizona Research Center | Phoenix | Arizona | United States | 85023 |
5 | Med Center | Carmichael | California | United States | 95608 |
6 | Triwest Research Associates | El Cajon | California | United States | 92020 |
7 | Westlake Medical | Thousand Oaks | California | United States | 91360 |
8 | Colorado Orthopedic Consultants | Englewood | Colorado | United States | 80110 |
9 | Chase Medical | Waterbury | Connecticut | United States | 06708 |
10 | Riverside Clinical Research | Edgewater | Florida | United States | 32132 |
11 | Suncoast Clinical Research | New Port Richey | Florida | United States | 34652 |
12 | Ormond Medical Arts | Ormond Beach | Florida | United States | 32174 |
13 | Tufts Medical Center | Boston | Massachusetts | United States | 02111 |
14 | Great Lakes Research Group | Bay City | Michigan | United States | 48706 |
15 | Healthcare Research Network | Hazelwood | Missouri | United States | 63042 |
16 | Fabio Orozco | Egg Harbor Township | New Jersey | United States | 08234 |
17 | PMG Research of Raleigh | Raleigh | North Carolina | United States | 27609 |
18 | New Horizons | Cincinnati | Ohio | United States | 45242 |
19 | Columbus Clinical Research | Columbus | Ohio | United States | 43213 |
20 | Blair Orphopedics | Altoona | Pennsylvania | United States | 16602 |
21 | West Houston Clinical Research | Houston | Texas | United States | 77055 |
Sponsors and Collaborators
- Fidia Farmaceutici s.p.a.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Fidia Farmaceutici s.p.a.
ClinicalTrials.gov Identifier:
NCT02187549
Other Study ID Numbers:
- EQE7-13-01
First Posted:
Jul 11, 2014
Last Update Posted:
Oct 5, 2015
Last Verified:
Oct 1, 2015
Keywords provided by Fidia Farmaceutici s.p.a.
Additional relevant MeSH terms: