A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AMG 403 in Subjects With Osteoarthritis Knee Pain

Osteoarthritis Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AMG 403 in Younger and Older Subjects With Osteoarthritis Knee Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02318407
• Other study ID #: 20060145
• Status: Completed
• Phase: Phase 1
• First received: December 2, 2014
• Last updated: December 12, 2014
• Start date: December 2006
• Est. completion date: March 2008

Study information

• Verified date: December 2014
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a sequential, randomized, double-blind, placebo controlled, multiple dose, dose escalation study in subjects with OA knee pain (n=32; 8/cohort). In each cohort, subjects will be randomized 3:1 to receive SC AMG 403 or placebo once every 4 weeks for a total of 4 doses (Q28D x 4).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Diagnosed with knee OA as determined by ACR criteria: Knee pain and radiographic osteophytes and at least 1 of the following 2 items: Morning stiffness 30 minutes, Crepitus on motion, a VAS pain score of = 30 mm for index knee at screening,

Exclusion Criteria:

• Weight of > 125 kg, Inflammatory arthropathy including secondary OA (eg, degenerative arthritis in patients with rheumatoid arthritis) as confirmed by a rheumatologist or investigator, Diagnosis of a condition other than knee OA that, in the investigator's opinion, may cause or affect pain or pain assessment in the index knee; these conditions may include but are not limited to radiculopathy or neuropathy, vasculopathy, fibromyalgia or active depression, Subjects taking neuromodulatory agents (antiepileptics or antidepressants) used as analgesic therapy for neuropathic pain

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• AMG 403
AMG 403 for the treatment of subjects with osteoarthritis
• Placebo
contains no active drug

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability as measured by subject incident of treatment-emergent adverse events, clinically significant changes in vital signs, physical examinations endpoints, clinical laboratory safety tests, and ECGs	Subject incident of treatment-emergent adverse events, clinically significant changes in vital signs, physical examinations endpoints, clinical laboratory safety tests, and ECGs	from 197 days to 211 days	Yes
Secondary	Pharmacokinetics profile of AMG 403 including Tmax, AUClast and Cmax	serum concentrations and derived PK parameters of AMG 403	from 197 days to 211 days	No

External Links

•   AmgenTrials clinical trials website