Study to Assess the Efficacy and Safety of Dysport® in the Treatment of Chronic Plantar Fasciitis - Full Text View

Sponsored by:	Ipsen
Information provided by:	Ipsen
ClinicalTrials.gov Identifier:	NCT00447876

Purpose

This study will investigate the hypothesis that the analgesic and inflammatory effect of a single injection of Dysport (200 MU) induces a significant reduction of symptoms in chronic cases of plantar fasciitis.

Condition	Intervention	Phase
Chronic Plantar Fasciitis	Drug: Botulinum type A toxin (Dysport®)	Phase II Phase III

MedlinePlus related topics: Botox

Drug Information available for: Clostridium botulinum toxin Botulinum toxin A Sodium chloride Chlorides

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Double-Blind, Placebo-Controlled, Randomised, Multicentre Study on the Efficacy and Safety of a Single Injection of Botulinum Toxin A (200 Units Dysport®) in the Treatment of Chronic Plantar Fasciitis

Further study details as provided by Ipsen:

Primary Outcome Measures:

Improvement of score value on the visual analogue scale for pain during weight-bearing in the last 48 hours in week 6. "Responder" is defined as a reduction in score value of ≥ 50% [ Time Frame: Week 6 after injection versus baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Gerbershagen Score [ Time Frame: Week 0, 18 ] [ Designated as safety issue: No ]
Pain intensity on the Visual Analogue Scale [ Time Frame: Week 0, 2, 6, 10, 14, 18 ] [ Designated as safety issue: No ]
Measurement of pressure pain with algorimeter: most severe pain experienced on the medial hindfoot [ Time Frame: Week 0, 2, 6, 10, 14, 18 ] [ Designated as safety issue: No ]
Force measurement by Brunner (Grade 0-5) [ Time Frame: Week 0, 2, 6, 10, 14, 18 ] [ Designated as safety issue: No ]
Global assessment by the investigator and the patient [ Time Frame: Week 2, 6, 10, 14, 18 ] [ Designated as safety issue: No ]
Tolerance of study drug (recording of drug side-effects) [ Time Frame: Week 2, 6, 10, 14, 18 ] [ Designated as safety issue: Yes ]
Adverse events [ Time Frame: Week 0, 2, 6, 10, 14, 18 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	July 2005
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Botulinum type A toxin (Dysport®) Placebo: 0,9% sodium chloride, 2 ml Drug: Botulinum type A toxin (Dysport®) 200 Units / 2 ml injected at the root of the plantar fascia
2: Placebo Comparator	Drug: Botulinum type A toxin (Dysport®) Placebo: 0,9% sodium chloride, 2 ml Drug: Botulinum type A toxin (Dysport®) 200 Units / 2 ml injected at the root of the plantar fascia

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Chronic plantar fasciitis (duration of disorder at least 4 months)
At least 4 points on the visual analogue scale (0-10) for the most severe pain within the last 48 hours
At least 2 previous unsuccessful conservative therapies
Age 18 and older

Exclusion Criteria:

Rheumatoid diseases (M. Bechterew, chronic poliarthritis, psoriasis-arthritis, para /post-infectious arthritis etc.)
Previous surgery in the affected area of the foot
Pre-treatment with Botulinum toxin A (only de novo patients)
Prohibited concomitant treatment: local injections during the study and 2 weeks prior to start of study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00447876

Contacts

Contact: Ipsen Recruitment Enquiries

clinical.trials@ipsen.com

Locations

Germany
University Hospital Charite, Campus Virchow, Musculoskeletal Centre, Orthopedic Clinic	Recruiting
Berlin, Germany, 13353
Orthopedic Practice	Recruiting
Weiden, Germany, 92637
Orthopedic Practice	Recruiting
Karlsruhe, Germany, 76133
Klinik für Orthopädie und Rheumatologie, Universitätsklinikum Gießen und Marburg GmbH	Recruiting
Standort Marburg, Germany
Orthopedic Practice Biberburg	Recruiting
Berlin, Germany, 14089
Orthocentre Munich	Terminated
Munich, Germany, 81547

Sponsors and Collaborators

Ipsen

Investigators

Study Director:

Bert Van Eijk, MD

Ipsen

More Information

Responsible Party:	Ipsen ( Bert Van Eijk )
Study ID Numbers:	A-94-52120-100
Study First Received:	March 13, 2007
Last Updated:	October 31, 2008
ClinicalTrials.gov Identifier:	NCT00447876
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Fasciitis, Plantar
Botulinum Toxins
Musculoskeletal Diseases

Fasciitis
Botulinum Toxin Type A
Foot Diseases

Additional relevant MeSH terms:

Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009