Safety, Tolerability, Pharmacokinetics and -Dynamics of Multiple Rising Oral Doses of BI 113823 in Patients Patients With Osteoarthritis of the Knee
Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Terminated
CT.gov ID
NCT01207973
Collaborator
(none)
36
1
1
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
36 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double
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)
Study Start Date
:
Sep 1, 2010
Actual Primary Completion Date
:
Jan 1, 2011
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Measures of pharmacodynamic effects [15 days]
- Standard pharmacokinetic parameters for single dose and steady state conditions will be assessed [15 days]
Eligibility Criteria
Criteria
Ages Eligible for Study:
35 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion criteria patients with osteoarthritis
Exclusion criteria
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 1272.2.1 Boehringer Ingelheim Investigational Site | Muenchen | Germany |
Sponsors and Collaborators
- Boehringer Ingelheim
Investigators
- Study Chair: Boehringer Ingelheim, Boehringer Ingelheim
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT01207973
Other Study ID Numbers:
- 1272.2
- 2010-018541-62
First Posted:
Sep 23, 2010
Last Update Posted:
Nov 5, 2013
Last Verified:
Nov 1, 2013