Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been terminated.
Information provided by:
Boehringer Ingelheim Identifier:
First received: September 22, 2010
Last updated: November 4, 2013
Last verified: November 2013
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.

Condition Intervention Phase
Drug: BI 113823
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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)

Resource links provided by NLM:

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Safety (Physical examination) [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]
  • Safety (Vital signs) [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]
  • Safety (12-lead ECG) [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]
  • Safety (Clinical laboratory tests) [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]
  • Safety (Adverse Events) [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]
  • Tolerability (Assessment of tolerability by investigator) [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Measures of pharmacodynamic effects [ Time Frame: 15 days ] [ Designated as safety issue: No ]
  • Standard pharmacokinetic parameters for single dose and steady state conditions will be assessed [ Time Frame: 15 days ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: September 2010
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   35 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion criteria patients with osteoarthritis

Exclusion criteria

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01207973

1272.2.1 Boehringer Ingelheim Investigational Site
Muenchen, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim Identifier: NCT01207973     History of Changes
Other Study ID Numbers: 1272.2  2010-018541-62 
Study First Received: September 22, 2010
Last Updated: November 4, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases processed this record on December 09, 2016