Safety, Tolerability, Pharmacokinetics and -Dynamics of M... | NCT01207973

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

NCT01207973

Sponsor

Boehringer Ingelheim

Status

Terminated

Last Update Posted

Nov 5, 2013Estimated

Enrollment

36Actual

Phase

Phase 1

Conditions

Osteoarthritis

Interventions

BI 113823

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2010-018541-62	EudraCT Number	EudraCT

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)

Status Module

Record Verification Date

Nov 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Jan 2011Actual

Completion Date

Not provided

First Submitted Date

Sep 22, 2010

First Submission Date that Met QC Criteria

Sep 22, 2010

First Posted Date

Sep 23, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 4, 2013

Last Update Posted Date

Nov 5, 2013Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BI 113823	Experimental	5 dose-groups of multiple oral doses of BI 113823	Drug: BI 113823

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BI 113823	Drug	5 dose-groups of multiple oral doses of BI 113823	BI 113823

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Measures of pharmacodynamic effects		15 days
Standard pharmacokinetic parameters for single dose and steady state conditions will be assessed		15 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria patients with osteoarthritis

Exclusion criteria

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
1272.2.1 Boehringer Ingelheim Investigational Site		München			Germany

Condition Browse Module

MeSH Terms

ID	Term
D010003	Osteoarthritis

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided