This study is currently recruiting participants. (see Contacts
and Locations)
Verified June 2014 by Ampio Pharmaceuticals. Inc.
Sponsor:Ampio Pharmaceuticals. Inc.
Information provided by (Responsible Party):Ampio
Pharmaceuticals. Inc.
ClinicalTrials.gov Identifier:NCT02024529First received:
December 26, 2013Last updated: June 29, 2014Last verified: June
2014History of Changes
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Randomized, Controlled Study to Evaluate Efficacy and Safety of
Intra-articular Ampion for OsteoarthritisPain in Knee
PurposeThis is a randomized, placebo-controlled, double-blind
study in which 500 patients with osteoarthritis (OA) knee pain will
be randomized to Ampionor placebo and followed for 20 weeks. The
clinical effects of treatment on OA pain will be evaluated during
clinic visits at 6, 12, and 20 weeksusing WOMAC osteoarthritis
Index and the Patient's Global Assessment of disease severity
(PGA). Safety will be assessed by recordingadverse events,
concomitant medications, physical examination, vital signs and
clinical laboratory tests.
Condition Intervention Phase
Osteoarthritis of the Knee Biological: Ampion Phase 3
Study Type: InterventionalStudy Design: Allocation:
Randomized
Endpoint Classification: Safety/Efficacy StudyIntervention
Model: Parallel AssignmentMasking: Double Blind (Subject,
Caregiver, Investigator, Outcomes Assessor)Primary Purpose:
Treatment
Official Title: A Phase 3 Randomized, Placebo-controlled,
Double-blind Study to Evaluate the Safety and Efficacy of a Single
Intra-articularInjection of AmpionTM (
Placebo Comparator: Placebo solution4 mL placebo intra-articular
injection
Biological: AmpionkDa ultrafiltrate of 5% human serum
albumin
Eligibility
Ages Eligible for Study: 35 Years to 85 YearsGenders Eligible
for Study: BothAccepts Healthy Volunteers: NoCriteriaInclusion
Criteria:
Clinical diagnosis and radiological evidence of symptomatic
osteoarthritis of the kneeModerate to severe pain
Exclusion Criteria:Other conditions in the knee, e.g., crystal
arthropathies, septic necrosis, joint replacement, major injury
within 12 months prior to screening,tense effusionsRequires ongoing
treatment with intra-articular pain medications or systemic
corticosteroids
Contacts and LocationsChoosing to participate in a study is an
important personal decision. Talk with your doctor and family
members or friends about deciding to join astudy. To learn more
about this study, you or your doctor may contact the study research
staff using the Contacts provided below. For generalinformation,
see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier:
NCT02024529
ContactsContact: Holli Loose, MSc 720-437-6528
[email protected]
LocationsUnited States, California
Quang Vo, MD RecruitingAnaheim, California, United States,
92801Contact: Michelle Cook 714-269-6161 [email protected]
Principal Investigator: Quang Vo, MD
Sponsors and CollaboratorsAmpio Pharmaceuticals.
Inc.InvestigatorsStudy Director: Vaughan Clift, MD Ampio
Pharmaceuticals. Inc.
More Information
No publications provided
Responsible Party: Ampio Pharmaceuticals. Inc.ClinicalTrials.gov
Identifier: NCT02024529 History of ChangesOther Study ID Numbers:
AP-004-AStudy First Received: December 26, 2013Last Updated: June
29, 2014Health Authority: United States: Food and Drug
Administration
Additional relevant MeSH terms:OsteoarthritisOsteoarthritis,
KneeArthritis
Joint DiseasesMusculoskeletal DiseasesRheumatic Diseases
ClinicalTrials.gov processed this record on July 14, 2014
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Randomized, Controlled Study to Evaluate Efficacy and Safety of
Intra-articular Ampion for Osteoarthritis Pain in Knee - Full Text
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Randomized, Controlled Study to Evaluate Efficacy and Safety of
Intra-articular Ampion for Osteoarthritis Pain in Knee
