Safety/Efficacy of Balicatib (AAE581) in Adults With Oste... | NCT00371670

Studies
Safety/Efficacy of Balicatib (AAE581) in Adults With Osteoarthritis of the Knee

NCT00371670

Sponsor

Novartis Pharmaceuticals

Status

Completed

Last Update Posted

Mar 28, 2017Actual

Enrollment

223Actual

Phase

Phase 2

Conditions

Knee Osteoarthritis

Interventions

balicatib (AAE581)

Countries

United States
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

Official Title

A Phase II, 12-month, Double-blind, Placebo-controlled, Dose-finding, Multicenter Study to Evaluate the Safety, Tolerability, and Disease Modifying Efficacy of Daily Oral AAE581 (10, 25 and 50 mg Tablets) in Patients With Painful Knee Osteoarthritis, Kellgren-Lawrence Grade 3 by X-ray

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2004

Primary Completion Date

Jul 2006Actual

Completion Date

Not provided

First Submitted Date

Aug 31, 2006

First Submission Date that Met QC Criteria

Aug 31, 2006

First Posted Date

Sep 4, 2006Estimated

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

Mar 24, 2017

Last Update Posted Date

Mar 28, 2017Actual

Description Module

Brief Summary

This study will test efficacy and safety of AAE581 compared to placebo in limiting cartilage loss in patients with painful knee osteoarthritis which is confirmed by X-ray

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

223Actual

Name	Type	Description	Arm Group Labels	Other Names
balicatib (AAE581)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in knee cartilage volume in the target compartment after 6 months

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in:
- Cartilage volume in the different regions of the knee after 6 and 12 months,
- Cartilage score (Whole Organ MRI Scoring system (WORMS)) in the different regions of the knee after 6 and 12 months,

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

At least one knee with osteoarthritis with Kellgren-Lawrence grade 3
Significant osteoarthritis pain in the knee
Presence of at least one of the risk factors: obesity (BMI > 28), osteoarthritis at other sites, knee effusion, family history of total joint replacement

Exclusion Criteria:

Women with childbearing potential
Secondary osteoarthritis
Treatment with intra-articular or systemic steroids
Inability to undergo MRI acquisition

Other protocol defined inclusion/exclusion criteria may apply.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 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
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pinnacle Research Group		Anniston	Alabama	36207	United States
Novartis

Condition Browse Module

MeSH Terms

ID	Term
D020370	Osteoarthritis, Knee
D010003	Osteoarthritis
D010146	Pain

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C529767	balicatib

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided