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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

Primary Purpose

Osteoarthritis

Status

Terminated

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

BI 113823

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria patients with osteoarthritis

Exclusion criteria

Sites / Locations

1272.2.1 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BI 113823

Arm Description

5 dose-groups of multiple oral doses of BI 113823

Outcomes

Primary Outcome Measures

Safety (Physical examination)

Safety (Vital signs)

Safety (12-lead ECG)

Safety (Clinical laboratory tests)

Safety (Adverse Events)

Tolerability (Assessment of tolerability by investigator)

Secondary Outcome Measures

Measures of pharmacodynamic effects

Standard pharmacokinetic parameters for single dose and steady state conditions will be assessed

Full Information

NCT ID

NCT01207973

First Posted

September 22, 2010

Last Updated

November 4, 2013

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT01207973

Brief Title

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

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Terminated

Study Start Date

September 2010 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

Double

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BI 113823

Arm Type

Experimental

Arm Description

5 dose-groups of multiple oral doses of BI 113823

Intervention Type

Drug

Intervention Name(s)

BI 113823

Intervention Description

5 dose-groups of multiple oral doses of BI 113823

Primary Outcome Measure Information:

Title

Safety (Physical examination)

Time Frame

15 days

Title

Safety (Vital signs)

Time Frame

15 days

Title

Safety (12-lead ECG)

Time Frame

15 days

Title

Safety (Clinical laboratory tests)

Time Frame

15 days

Title

Safety (Adverse Events)

Time Frame

15 days

Title

Tolerability (Assessment of tolerability by investigator)

Time Frame

15 days

Secondary Outcome Measure Information:

Title

Measures of pharmacodynamic effects

Time Frame

15 days

Title

Standard pharmacokinetic parameters for single dose and steady state conditions will be assessed

Time Frame

15 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria patients with osteoarthritis Exclusion criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Boehringer Ingelheim

Organizational Affiliation

Boehringer Ingelheim

Official's Role

Study Chair

Facility Information:

Facility Name

1272.2.1 Boehringer Ingelheim Investigational Site

City

Muenchen

Country

Germany

12. IPD Sharing Statement

Links:

URL

http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1272/1272.2_Statement.pdf

Description

Related Info

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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

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