Clinical Trial: Study to Assess the Efficacy and Safety of Dysport® in Upper Back Myofascial Pain Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II Multicentre Multinational Prospective Randomised Double-Blind Placebo-Controlled Study Assessing the Efficacy and Safety of a Single Application of Three Doses of Dysport® in Patients

Brief Summary: The main purpose of this study is to determine which is the best dose of a drug known as Dysport to give when treating one's type of upper back pain. The study will also examine the side effects of this treatment and its overall effect on one's disorder.

Detailed Summary:
Sponsor: Ipsen

Current Primary Outcome: Change in pain score for ‘overall pain of the day during activity’ between baseline and Week 6

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in pain score for ‘worst pain of the day during activity’ between baseline and Week 6
  • Change in pain score for ‘overall pain of the day at rest’ between baseline and Week 6
  • Spontaneously reported adverse events and changes in physical examination and vital signs
  • Change in pain score for ‘overall pain during activity’ between baseline and Weeks 6, 12 and 16
  • Time to onset of pain relief
  • Change in each of the 8 dimensions of the Short Form Quality of Life questionnaire with 36 items (SF36) at Weeks 6, 12 and 16 from baseline
  • Change in the Hospital Anxiety and Depression Scale (HADS) anxiety score, depression score and aggregate score at Weeks 6, 12 and 16 from baseline
  • Clinical Global Impression of Change (CGIC) assessed using a 7-point numerical rating scale at Week 16
  • Patient’s Global Impression of Change (PGIC) assessed using a 7-point numerical rating scale at Week 16


Original Secondary Outcome:

  • • Change in pain score for ‘worst pain of the day during activity’ between baseline and Week 6.
  • • Change in pain score for ‘overall pain of the day at rest’ between baseline and Week 6.
  • Spontaneously reported adverse events and changes in physical examination and vital signs.
  • • Change in pain score for ‘overall pain during activity’ between baseline and Weeks 6, 12 and 16.
  • • Time to onset of pain relief.
  • • Change in each of the 8 dimensions of the Short Form Quality Of Life questionnaire with 36 Items (SF36) at Weeks 6, 12 and 16 from baseline.
  • • Change in the Hospital Anxiety and Depression Scale (HADS) anxiety score, depression score and aggregate score at Weeks 6, 12 and 16 from baseline.
  • • Clinical Global Impression of Change (CGIC) assessed using a 7-point numerical rating scale at Week 16.
  • • Patient’s Global Impression of Change (PGIC) assessed using a 7-point numerical rating scale at Week 16.


Information By: Ipsen

Dates:
Date Received: August 23, 2005
Date Started: March 2005
Date Completion: May 2006
Last Updated: January 9, 2007
Last Verified: January 2007