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

NCT ID: NCT01207973

Last Updated: 2013-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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BI 113823

5 dose-groups of multiple oral doses of BI 113823

Group Type EXPERIMENTAL

BI 113823

Intervention Type DRUG

5 dose-groups of multiple oral doses of BI 113823

Interventions

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BI 113823

5 dose-groups of multiple oral doses of BI 113823

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Inclusion criteria patients with osteoarthritis

Exclusion criteria
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Boehringer Ingelheim

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1272.2.1 Boehringer Ingelheim Investigational Site

München, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2010-018541-62

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1272.2

Identifier Type: -

Identifier Source: org_study_id