Safety, Tolerability, Pharmacokinetics and -Dynamics of Multiple Rising Oral Doses of BI 113823 in Patients Patients With Osteoarthritis of the Knee

Boehringer Ingelheim

Status and phase: Terminated; Phase 1

Conditions: Osteoarthritis

Treatments: Drug: BI 113823

Study type: Interventional

Funder types: Industry

Identifiers

NCT01207973

1272.2

2010-018541-62 (EudraCT Number)

Details and patient eligibility

About

The objective of the study is to investigate the safety and tolerability of BI 113823 in male and female patients with osteoarthritis, following oral administration of BI 113823 with repeated rising doses.

Enrollment: 36 patients

Sex: All

Ages: 35 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria patients with osteoarthritis

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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36 participants in 1 patient group

BI 113823

Experimental group

Description:

5 dose-groups of multiple oral doses of BI 113823

Treatment:

Drug: BI 113823