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

Tracking Information

First Received Date ^ICMJE

March 13, 2007

Last Updated Date

October 20, 2009

Start Date ^ICMJE

July 2005

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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%

Change History

Complete list of historical versions of study NCT00447876 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Gerbershagen Score at first visit and at week 18
Pain intensity on the Visual Analogue Scale
Measurement of pressure pain with algorimeter: most severe pain experienced on the medial hindfoot
Force measurement by Brunner (Grade 0-5)
Global assessment by the investigator and the patient at weeks 2, 6, 10, 14, 18 post injection
Tolerance of study drug (recording of drug side-effects)
Adverse events

Descriptive Information

Brief Title ^ICMJE

Study to Assess the Efficacy and Safety of Dysport® in the Treatment of Chronic Plantar Fasciitis

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase II, Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Chronic Plantar Fasciitis

Intervention ^ICMJE

Drug: Botulinum type A toxin (Dysport®)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2009

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 polyarthritis, 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00447876

Responsible Party

Bert Van Eijk, Ipsen

Study ID Numbers ^ICMJE

A-94-52120-100

Study Sponsor ^ICMJE

Ipsen

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Bert Van Eijk, MD

Ipsen

Information Provided By

Ipsen

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP