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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00447876
Recruitment Status : Completed
First Posted : March 15, 2007
Results First Posted : June 23, 2017
Last Update Posted : November 22, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

Tracking Information
First Submitted Date  ICMJE March 13, 2007
First Posted Date  ICMJE March 15, 2007
Results First Submitted Date  ICMJE April 6, 2017
Results First Posted Date  ICMJE June 23, 2017
Last Update Posted Date November 22, 2019
Study Start Date  ICMJE July 2005
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 6, 2017)
Responders Rate at Week 6 (Pain While Moving) [ Time Frame: Baseline and Week 6 ]
The responder rate was defined as the percentage of patients whose pain score while moving during the last 48 hours, measured by means of a 10 cm Visual Analogue Scale (VAS, 0 = no pain, 10 = maximum pain) decreased by at least 50% at Week 6 as compared to baseline. Pain at movement is the cardinal symptom of plantar fasciitis and the 10 cm VAS is a reference method for the assessment of pain intensity.
Original Primary Outcome Measures  ICMJE
 (submitted: March 13, 2007)
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
Current Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2017)
  • Changes From Baseline in Gerbershagen's Score at Week 18 [ Time Frame: Baseline and Week 18 ]
    The Gerbershagen scale gives a global score ranging between I and III, with lower scores reflecting less impact of pain in terms of temporal, spatial aspects, drug taking behaviour and utilization of the health care system. The changes in Gerbershagen's global scores from baseline to Week 18 are reported as percentage of patients for each of the specified categories.
  • Changes From Baseline in Maximum Pain (Pain While Moving) at Each Visit [ Time Frame: Baseline and Weeks 2, 6, 10, 14 and 18 ]
    Assessments of the pain intensity while moving (maximum pain during the previous 48 hours) were performed by means of a 10 cm VAS (0 = no pain, 10 = maximum pain) at each visit. The changes from baseline, expressed as Pain Intensity Difference (PID) values at each indicated timepoint are reported.
  • Assessment of Sum of Pain Intensity Difference (SPID) for Maximum Pain for Overall Study [ Time Frame: Baseline and Weeks 2, 6, 10, 14 and 18 ]
    Assessments of the pain intensity while moving (maximum pain during the previous 48 hours) were performed by means of a 10 cm VAS (0 = no pain, 10 = maximum pain) at each visit. The PID values at each timepoint were determined by comparison to baseline, followed by calculation of the area under the curve (AUC) of PID as a function of time (i.e. SPID). The least square (LS) means of SPID, adjusted for the baseline value of pain while moving are reported.
  • Changes From Baseline in Continuous Pain (Pain At Rest) at Each Visit [ Time Frame: Baseline and Weeks 2, 6, 10, 14 and 18 ]
    Assessments of the pain intensity while at rest (continuous pain during the previous 48 hours) were performed by means of a 10 cm VAS (0 = no pain, 10 = maximum pain) at each visit. The changes from baseline, expressed as PID values at each indicated timepoint are reported.
  • Assessment of SPID for Continuous Pain for Overall Study [ Time Frame: Baseline and Weeks 2, 6, 10, 14 and 18 ]
    Assessments of the pain intensity while at rest (continuous pain during the previous 48 hours) were performed by means of a 10 cm VAS (0 = no pain, 10 = maximum pain) at each visit. The PID values at each timepoint were determined by comparison to baseline, followed by calculation of the AUC of PID as a function of time (i.e. SPID). The LS means for SPID, adjusted for the baseline value of pain at rest are reported.
  • Changes From Baseline in Pain Threshold at Each Visit [ Time Frame: Baseline and Weeks 2, 6, 10, 14 and 18 ]
    The maximum pain felt in the medial back foot was measured using an algometer. The pain threshold corresponded to the maximum pressure at which pain was still tolerated. Changes from baseline, expressed as pain threshold differences at each indicated timepoint are reported.
  • Assessment of Sum of Pain Threshold Differences (by Measurement of AUC) for Overall Study [ Time Frame: Baseline and Weeks 2, 6, 10, 14 and 18 ]
    Assessments of the pain threshold using an algometer (which was the pressure corresponding to the maximum tolerated pain) were performed at each visit. Pain threshold differences at each timepoint were determined by comparison to baseline, followed by calculation of the AUC of the pain threshold difference as a function of time. The LS means of AUC, adjusted for the baseline value of pain threshold are reported.
  • Changes From Baseline in Pressure Threshold (With Algometer) at Each Visit [ Time Frame: Baseline and Weeks 2, 6, 10, 14 and 18 ]
    Pressure pain in the medial back foot was measured using an algometer. Pressure threshold corresponded to the minimum pressure causing pain. The changes from baseline, expressed as pressure threshold differences at each indicated timepoint are reported.
  • Assessment of Sum of Pressure Threshold Differences (by Measurement of AUC) for Overall Study [ Time Frame: Baseline and Weeks 2, 6, 10, 14 and 18 ]
    Assessments of the pressure threshold using an algometer (which corresponded to the minimum pressure causing pain) were performed at each visit. Pressure threshold differences at each timepoint were determined by comparison to baseline, followed by calculation of the AUC of the pressure threshold difference as a function of time. The LS means of AUC, adjusted for the baseline value of pressure threshold are reported.
  • Assessment of Dorsal Extension / Plantar Flexion Range of Motion (ROM) of the Affected Foot At Week 18 [ Time Frame: Baseline and Week 18 ]
    Dorsal extension and plantar flexion of the affected foot were assessed at baseline and at Week 18. A ROM of approximately 70 degrees is considered to be normal. The LS means, adjusted for the baseline value are reported.
  • Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit [ Time Frame: Baseline and Weeks 2, 6, 10, 14 and 18 ]
    A global assessment of the patient's current condition relative to baseline was performed by the Investigator at each visit using 5 level scale: significantly better, slightly better, unchanged, slightly worse, significantly worse. The number of patients for each variable at each indicated timepoint are reported.
  • Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit [ Time Frame: Baseline and Weeks 2, 6, 10, 14 and 18 ]
    A global assessment of the patient's current condition relative to baseline was performed by the patient at each visit using a 5 level scale: significantly better, slightly better, unchanged, slightly worse, significantly worse. The number of patients for each variable at each indicated timepoint are reported.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2007)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Plantar Fasciitis
Intervention  ICMJE
  • Biological: Botulinum toxin type A
    Botulinum type A toxin (Dysport®): 200 Units injected at the root of the plantar fascia
    Other Name: AbobotulinumtoxinA (Dysport®)
  • Drug: Placebo
    0.9% sodium chloride: 2 ml injected at the root of the plantar fascia
Study Arms  ICMJE
  • Experimental: Botulinum type A toxin (Dysport®)
    Intervention: Biological: Botulinum toxin type A
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Peterlein CD, Funk JF, Hölscher A, Schuh A, Placzek R. Is botulinum toxin A effective for the treatment of plantar fasciitis? Clin J Pain. 2012 Jul;28(6):527-33. doi: 10.1097/AJP.0b013e31823ae65a.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 13, 2007)
40
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2009
Actual 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00447876
Other Study ID Numbers  ICMJE A-94-52120-100
2004-002533-39 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Ipsen
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Ipsen
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ipsen Medical Director Ipsen
PRS Account Ipsen
Verification Date November 2019

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