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NCT00303056·Phase 2·INTERVENTIONAL

Efficacy and Safety Study of Intra-articular Multiple Doses of Icatibant in Patients With Painful Knee Osteoarthritis

IcatibantInflammationCompleted

Status

Completed

Phase

Phase 2

Enrollment

590

Locations

5

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full detailed description

This is a multinational, randomized, placebo-controlled study to be conducted in Europe and the US. Study medication will be administered by intra-articular injection 3 times in weekly intervals, being followed by an observation period of further 11 weeks.

Interventions

Treatment arms and agents.

DRUG

HOE140 Icatibant

Timeline

From registration to results.

  1. First posted

    Mar 15, 2006

  2. Study start

    Feb 2006

  3. Primary completion

    Jul 2007

  4. Study completion

    Jul 2007

  5. Results posted

    Not reported

  6. Registry updated

    Feb 17, 2012

Outcomes

What the study measures.

Primary outcomes

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

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.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * Male and female subjects with painful osteoarthritis of the knee. Exclusion Criteria: * 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).

Study locations

5 registered sites.

Austria · Czechia · Germany · Poland · United States. Showing up to 24 locations stored in the fast local snapshot.

Administrative Office

Bridgewater, New Jersey, United States

Administrative Office

Vienna, Austria

Administrative Office

Prague, Czechia

Administrative Office

Berlin, Germany

Administrative Office

Warsaw, Poland

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

Related trials

More studies on Icatibant.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.

TrialsIcatibant trial dashboard →