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

November 4, 2013 updated by: Boehringer Ingelheim

Safety, Tolerability, Pharmacokinetics and Pharmacodynamic of Multiple Rising Oral Doses (50, 100, 200 and 350 mg qd and 100 mg Bid for 12 Days) of BI 113823 as Tablet in Male and Female Patients With Osteoarthritis of the Knee (Randomised, Double-blind, Placebo-controlled Within the Dose Groups, Clinical Phase I)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Muenchen, Germany
        • 1272.2.1 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria patients with osteoarthritis

Exclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BI 113823
5 dose-groups of multiple oral doses of BI 113823
Drug: BI 113823
5 dose-groups of multiple oral doses of BI 113823

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety (Physical examination)
Time Frame: 15 days
15 days
Safety (Vital signs)
Time Frame: 15 days
15 days
Safety (12-lead ECG)
Time Frame: 15 days
15 days
Safety (Clinical laboratory tests)
Time Frame: 15 days
15 days
Safety (Adverse Events)
Time Frame: 15 days
15 days
Tolerability (Assessment of tolerability by investigator)
Time Frame: 15 days
15 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Measures of pharmacodynamic effects
Time Frame: 15 days
15 days
Standard pharmacokinetic parameters for single dose and steady state conditions will be assessed
Time Frame: 15 days
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

September 22, 2010

First Submitted That Met QC Criteria

September 22, 2010

First Posted (Estimate)

September 23, 2010

Study Record Updates

Last Update Posted (Estimate)

November 5, 2013

Last Update Submitted That Met QC Criteria

November 4, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1272.2
  • 2010-018541-62 (EudraCT Number: EudraCT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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