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Safety and Efficacy of Two Dosages of Diractin® in Osteoarthritis (OA)

Primary Purpose

Osteoarthritis of the Knee

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

ketoprofen in Diractin®

Placebo

celecoxib

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee

Eligibility Criteria

46 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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;
Inflammatory GI disease (e.g. M. Crohn, colitis ulcerosa)
Serum creatinine levels > 2.5 milligrams/deciliter (mg/dL)
ALT or AST levels ≥ 5 times the ULN
Unable to discontinue analgesic therapy including opioids, NSAID´s, tramadol, muscle relaxants, gabapentin, pregabalin, duloxetine, venlafaxine, capsaicine or other drugs approved or used for the treatment of pain for the duration of the study

Sites / Locations

IDEA Investigational Site
Klaus-Miehlke-Klinik
NZOZ Nasz Lekarz
Chapel Allerton Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

pain subscale of the WOMAC

Secondary Outcome Measures

Patient global assessment of response to therapy

function subscale of the WOMAC

Full Information

NCT ID

NCT00716547

First Posted

July 14, 2008

Last Updated

October 15, 2009

Sponsor

IDEA AG

1. Study Identification

Unique Protocol Identification Number

NCT00716547

Brief Title

Safety and Efficacy of Two Dosages of Diractin® in Osteoarthritis (OA)

Official Title

Multicenter, Randomized, Double-blind, Placebo- and Active-controlled Study of Safety and Efficacy of Two Dosages of Epicutaneously Applied Diractin® (Ketoprofen in Transfersome® Gel) for the Treatment of Osteoarthritis of the Knee

Study Type

Interventional

2. Study Status

Record Verification Date

October 2009

Overall Recruitment Status

Completed

Study Start Date

May 2008 (undefined)

Primary Completion Date

March 2009 (Actual)

Study Completion Date

May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

IDEA AG

4. Oversight

Data Monitoring Committee

5. Study Description

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®.

Detailed Description

The study will investigate safety and efficacy of 2 dosages of Diractin®at relieving the signs and symptoms of knee OA, including the primary endpoint of patient assessment of pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis of the Knee

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1399 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

ketoprofen in Diractin®

Intervention Description

50 mg (b.i.d.)

Intervention Type

Drug

Intervention Name(s)

ketoprofen in Diractin®

Intervention Description

100 mg (b.i.d.)

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

b.i.d.

Intervention Type

Drug

Intervention Name(s)

celecoxib

Intervention Description

100 mg (b.i.d.)

Primary Outcome Measure Information:

Title

pain subscale of the WOMAC

Time Frame

week 12

Secondary Outcome Measure Information:

Title

Patient global assessment of response to therapy

Time Frame

week 12

Title

function subscale of the WOMAC

Time Frame

week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

46 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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; Inflammatory GI disease (e.g. M. Crohn, colitis ulcerosa) Serum creatinine levels > 2.5 milligrams/deciliter (mg/dL) ALT or AST levels ≥ 5 times the ULN Unable to discontinue analgesic therapy including opioids, NSAID´s, tramadol, muscle relaxants, gabapentin, pregabalin, duloxetine, venlafaxine, capsaicine or other drugs approved or used for the treatment of pain for the duration of the study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

IDEA AG Clinical Trial

Organizational Affiliation

IDEA AG

Official's Role

Study Director

Facility Information:

Facility Name

IDEA Investigational Site

City

Prague 2

ZIP/Postal Code

128 50

Country

Czech Republic

Facility Name

Klaus-Miehlke-Klinik

City

Wiesbaden

ZIP/Postal Code

65191

Country

Germany

Facility Name

NZOZ Nasz Lekarz

City

Torun

ZIP/Postal Code

87-100

Country

Poland

Facility Name

Chapel Allerton Hospital

City

Leeds

ZIP/Postal Code

LS7 4SA

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

23542612

Citation

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.

Results Reference

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Safety and Efficacy of Two Dosages of Diractin® in Osteoarthritis (OA)

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