Safety and Tolerability of PG110 in Patients With Knee Osteoarthritis Pain

Abbott

Status and phase: Completed; Phase 1

Conditions: Osteoarthritis, Knee

Treatments: Biological: PG110; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00941746

2008-006219-19 (EudraCT Number)

PG110-01

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and tolerability of a single intravenous dose of PG110, a monoclonal antibody that inhibits the effects of the naturally occurring substance, nerve growth factor (NGF).

Enrollment: 56 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Moderate to severe pain attributed to knee osteoarthritis

Exclusion criteria

• Significant comorbidity
• Significant pain states other than osteoarthritis
• Concomitant medications that might affect assessments

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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56 participants in 9 patient groups

Lowest dose of PG110

Experimental group

Description:

single, slow intravenous infusion

Treatment:

Biological: PG110

Biological: PG110

Biological: PG110

Biological: PG110

Biological: PG110

Biological: PG110

Biological: PG110

Biological: PG110

Second dose of PG110

Experimental group

Description:

single, slow intravenous infusion

Treatment:

Biological: PG110

Biological: PG110

Biological: PG110

Biological: PG110

Biological: PG110

Biological: PG110

Biological: PG110

Biological: PG110

Third dose of PG110

Experimental group

Description:

single, slow intravenous infusion

Treatment:

Biological: PG110

Biological: PG110

Biological: PG110

Biological: PG110

Biological: PG110

Biological: PG110

Biological: PG110

Biological: PG110

Fourth dose of PG110

Experimental group

Description:

single, slow intravenous infusion

Treatment:

Biological: PG110

Biological: PG110

Biological: PG110

Biological: PG110

Biological: PG110

Biological: PG110

Biological: PG110

Biological: PG110

Fifth dose of PG110

Experimental group

Description:

single, slow intravenous infusion

Treatment:

Biological: PG110

Biological: PG110

Biological: PG110

Biological: PG110

Biological: PG110

Biological: PG110

Biological: PG110

Biological: PG110

Top dose of PG110

Experimental group

Description:

single, slow intravenous infusion

Treatment:

Biological: PG110

Biological: PG110

Biological: PG110

Biological: PG110

Biological: PG110

Biological: PG110

Biological: PG110

Biological: PG110

Placebo

Experimental group

Description:

single, slow intravenous infusion that matches PG110 in appearance

Treatment:

Biological: Placebo

Seventh Dose of PG110

Experimental group

Description:

single, slow intravenous infusion

Treatment:

Biological: PG110

Biological: PG110

Biological: PG110

Biological: PG110

Biological: PG110

Biological: PG110

Biological: PG110

Biological: PG110

Eight Dose of PG110

Experimental group

Description:

single, slow intravenous infusion

Treatment:

Biological: PG110

Biological: PG110

Biological: PG110

Biological: PG110

Biological: PG110

Biological: PG110

Biological: PG110

Biological: PG110