NCT00303056

Brief Summary

The primary objective is to compare the overall treatment effect on pain relief between icatibant and placebo. The secondary objectives are to assess the efficacy of icatibant in term of onset, extent and duration of pain relief relative to triamcinolone, to evaluate the safety of icatibant, to evaluate overall conditions of daily life after treatment with icatibant, to assess systemic exposure of icatibant following intra-articular injection.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
590

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2006

Shorter than P25 for phase_2

Geographic Reach
5 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 14, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 15, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

February 17, 2012

Status Verified

February 1, 2012

Enrollment Period

1.4 years

First QC Date

March 14, 2006

Last Update Submit

February 15, 2012

Conditions

Joint Disease

Keywords

Osteoarthritisknee

Outcome Measures

Primary Outcomes (1)

  • Pain during activity, at rest and at night will be measured daily via an electronic patient diary (EPD) using a 100-unit visual analog scale (VAS).

Secondary Outcomes (1)

  • Patient global assessment assessed daily as well as WOMAC scores at each visit and intake of rescue medication daily via EPD recording. Safety assessed at each visit and pharmacokinetics at visits 2, 3 & 4.

Interventions

HOE140 IcatibantDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female subjects with painful osteoarthritis of the knee.

You may not qualify if:

  • Subjects presenting with diagnosis of OA \< 3 months and an OA grading \< K\&L grade II, with any condition with impact on on the target indication, any test-compound-related condition, any study-related condition (all those conditions detailled in the CSP).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Administrative Office

Bridgewater, New Jersey, 08807, United States

Location

Administrative Office

Vienna, DCA 1220, Austria

Location

Administrative Office

Prague, 160 00, Czechia

Location

Administrative Office

Berlin, D-10785, Germany

Location

Administrative Office

Warsaw, 02-672, Poland

Location

MeSH Terms

Conditions

Joint DiseasesOsteoarthritis

Interventions

icatibant

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesArthritisRheumatic Diseases

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2006

First Posted

March 15, 2006

Study Start

February 1, 2006

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

February 17, 2012

Record last verified: 2012-02

Locations

PL(1)AU(1)US(1)CZ(1)DE(1)