NCT00716547

Brief Summary

The purpose of this study is to provide replicated evidence of safety and efficacy of 50 mg and 100 mg ketoprofen in Diractin®.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
1,399

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 2008

Shorter than P25 for phase_3

Geographic Reach
4 countries

4 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 16, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

October 16, 2009

Status Verified

October 1, 2009

Enrollment Period

10 months

First QC Date

July 14, 2008

Last Update Submit

October 15, 2009

Conditions

Osteoarthritis of the Knee

Outcome Measures

Primary Outcomes (1)

  • pain subscale of the WOMAC

    week 12

Secondary Outcomes (2)

  • Patient global assessment of response to therapy

    week 12

  • function subscale of the WOMAC

    week 12

Study Arms (4)

1

EXPERIMENTAL
Drug: ketoprofen in Diractin®

2

EXPERIMENTAL
Drug: ketoprofen in Diractin®

3

ACTIVE COMPARATOR
Drug: celecoxib

4

PLACEBO COMPARATOR
Drug: Placebo

Interventions

ketoprofen in Diractin®DRUG

50 mg (b.i.d.)

1
PlaceboDRUG

b.i.d.

4
celecoxibDRUG

100 mg (b.i.d.)

3

Eligibility Criteria

Age46 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed consent signed and dated
  • Age \> 45 years
  • Class I-III OA of the knee and subject meets American College of Rheumatology (ACR) clinical classification criteria for osteoarthritis of the knee

You may not qualify if:

  • Skin lesions or dermatological diseases in the treatment area
  • Directly or indirectly involved in the conduct and administration of this study
  • Received any investigational medicinal product within 30 days prior to Screening Visit or participation in any previous clinical study with Diractin®
  • Pregnancy or lactation
  • Residents of psychiatric wards, prisons or other state institutions
  • Malignancy within the past 2 years
  • Depressive disorders requiring treatment with tricyclics, treatment with other antidepressants must be stable for 3 months prior to screening and throughout the study
  • Epilepsy
  • Schizophrenia
  • Neuropathic pain and any other pain condition requiring chronic use of pain medication
  • Known hypersensitivity or allergy (including photoallergy) to NSAID´s including ketoprofen, celecoxib, sulfonamides and ingredients used in pharmaceutical products including galactose
  • Peripheral arterial disease and/or cerebrovascular disease
  • History of stroke or myocardial infarction
  • Congestive Heart failure NYHA Class II-IV
  • History of pancreatitis or peptic ulcers;
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

IDEA Investigational Site

Prague, 128 50, Czechia

Location

Klaus-Miehlke-Klinik

Wiesbaden, 65191, Germany

Location

NZOZ Nasz Lekarz

Torun, 87-100, Poland

Location

Chapel Allerton Hospital

Leeds, LS7 4SA, United Kingdom

Location

Related Publications (1)

  • Conaghan PG, Dickson J, Bolten W, Cevc G, Rother M. A multicentre, randomized, placebo- and active-controlled trial comparing the efficacy and safety of topical ketoprofen in Transfersome gel (IDEA-033) with ketoprofen-free vehicle (TDT 064) and oral celecoxib for knee pain associated with osteoarthritis. Rheumatology (Oxford). 2013 Jul;52(7):1303-12. doi: 10.1093/rheumatology/ket133. Epub 2013 Mar 28.

    PMID: 23542612DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

KetoprofenCelecoxib

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsBenzenesulfonamidesSulfonamidesAmidesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • IDEA AG Clinical Trial

    IDEA AG

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 14, 2008

First Posted

July 16, 2008

Study Start

May 1, 2008

Primary Completion

March 1, 2009

Study Completion

May 1, 2009

Last Updated

October 16, 2009

Record last verified: 2009-10

Locations

GB(1)DE(1)CZ(1)PL(1)