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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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ClinicalTrials.gov Identifier: NCT01207973
Recruitment Status : Terminated
First Posted : September 23, 2010
Last Update Posted : November 5, 2013
Information provided by:

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
Osteoarthritis Drug: BI 113823 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
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 : September 2010
Primary Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

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 :
  1. Safety (Physical examination) [ Time Frame: 15 days ]
  2. Safety (Vital signs) [ Time Frame: 15 days ]
  3. Safety (12-lead ECG) [ Time Frame: 15 days ]
  4. Safety (Clinical laboratory tests) [ Time Frame: 15 days ]
  5. Safety (Adverse Events) [ Time Frame: 15 days ]
  6. Tolerability (Assessment of tolerability by investigator) [ Time Frame: 15 days ]

Secondary Outcome Measures :
  1. Measures of pharmacodynamic effects [ Time Frame: 15 days ]
  2. Standard pharmacokinetic parameters for single dose and steady state conditions will be assessed [ Time Frame: 15 days ]

Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion criteria patients with osteoarthritis

Exclusion criteria

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
ClinicalTrials.gov Identifier: NCT01207973     History of Changes
Other Study ID Numbers: 1272.2
2010-018541-62 ( EudraCT Number: EudraCT )
First Posted: September 23, 2010    Key Record Dates
Last Update Posted: November 5, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases