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)
• Enrollment: 332
• Locations: 21
• Arms: 2
• Duration (Months): 21
• Patients Per Site: 15.8
• Patients Per Site Per Month: 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
Knee Osteoarthritis	Device: HYMOVIS; Device: Placebo	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: HYADD(TM) 4 Hydrogel Intra-Articular Injection
Placebo Comparator: Placebo Saline Intra-Articular Injection	Device: Placebo; Intra-Articular Injection; Other Names: Placebo Intra-Articular Injection

Outcome Measures

Primary Outcome Measures

1. Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Sub-score [26 weeks]

Secondary Outcome Measures

1. 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.: Hyaluronic Acid; Osteoarthritis; Knee; Hyaluronan; Viscoelastic; Hydrogel
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee

Study Results

No Results Posted as of Oct 5, 2015