NCT01207973

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 23, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Last Updated

November 5, 2013

Status Verified

November 1, 2013

Enrollment Period

4 months

First QC Date

September 22, 2010

Last Update Submit

November 4, 2013

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (6)

  • Safety (Physical examination)

    15 days

  • Safety (Vital signs)

    15 days

  • Safety (12-lead ECG)

    15 days

  • Safety (Clinical laboratory tests)

    15 days

  • Safety (Adverse Events)

    15 days

  • Tolerability (Assessment of tolerability by investigator)

    15 days

Secondary Outcomes (2)

  • Measures of pharmacodynamic effects

    15 days

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

    15 days

Study Arms (1)

BI 113823

EXPERIMENTAL

5 dose-groups of multiple oral doses of BI 113823

Drug: BI 113823

Interventions

BI 113823DRUG

5 dose-groups of multiple oral doses of BI 113823

BI 113823

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1272.2.1 Boehringer Ingelheim Investigational Site

München, Germany

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 22, 2010

First Posted

September 23, 2010

Study Start

September 1, 2010

Primary Completion

January 1, 2011

Last Updated

November 5, 2013

Record last verified: 2013-11

Locations

DE(1)