Study to Assess the Efficacy and Safety of Dysport® in Upper Back Myofascial Pain Syndrome
This study has been completed.
Sponsor:
Ipsen
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT00134810
First received: August 23, 2005
Last updated: January 9, 2007
Last verified: January 2007
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Myofascial Pain Syndromes |
Drug: Botulinum type A toxin (Dysport®) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 With Upper Back Myofascial Pain Syndrome |
Resource links provided by NLM:
Further study details as provided by Ipsen:
Primary Outcome Measures:
- Change in pain score for ‘overall pain of the day during activity’ between baseline and Week 6
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 340 |
| Study Start Date: | March 2005 |
| Estimated Study Completion Date: | May 2006 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Moderate-severe pain in upper back
- Myofascial pain syndrome for more than 6 months
- Active trigger points in upper back
Exclusion Criteria:
- Fibromyalgia and other non-myofascial pain conditions of upper back
- Duration of myofascial pain syndrome no longer than 24 months
- Steroid injections during previous 3 months
- Anaesthetic injection at trigger points during previous 1 month
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00134810
Locations
| Czech Republic | |
| Pain Treatment Centre, Anesthesiology & Resuscitation, St Ann Teaching Hospital | |
| Brno, Czech Republic, 656 91 | |
| Dept Neurology, Teaching Hospital Olomouc | |
| Olomouc, Czech Republic, 775 20 | |
| Institute of Rheumatology | |
| Praha, Czech Republic, 12850 | |
| Germany | |
| Neurology Clinic, Klinikum der Ruhr-Universitat Bochum | |
| Bochum, Germany, 44789 | |
| Schmerzzentrum Frankfurt | |
| Frankfurt am Main, Germany, 60311 | |
| Schmerzzentrum Goppingen | |
| Goppingen, Germany, 73033 | |
| Klinik fur Anaesthesiologie und Intensivtherapie | |
| Jena, Germany, 07747 | |
| Neurologisch-Verhaltensmedizinische Schmerzklinik Kiel | |
| Kiel, Germany, 24149 | |
| Clinic for Neurology, Westfalische Wilhelmsuniversitat | |
| Munster, Germany, 48129 | |
| Aukammallee 33 | |
| Wiesbaden, Germany, 65191 | |
| Italy | |
| Fondazione Salvatore Maugeri | |
| Montescano, Italy, 27040 | |
| Azienda Ospedaliera di Padova | |
| Padova, Italy, 35128 | |
| Poland | |
| Centrum Kliniczno-Badawcze | |
| Elblag, Poland, 82300 | |
| Osrodek Badan Klinicznych | |
| Lublin, Poland, 20022 | |
| Nasz Lekarz NZOZ Praktyka Grupowa Lekarzy | |
| Torun, Poland, 87100 | |
| Centrum Medyczne OSTEOMED NZOZ | |
| Warsaw, Poland, 02341 | |
| Portugal | |
| Hospital de Santa Maria | |
| Lisbon, Portugal, 1649-035 | |
| Spain | |
| Hospital Univ Germans Trias i Pujol | |
| Badalona, Spain, 08916 | |
| Hospedale Clinic I Provincial de Barcelona | |
| Barcelona, Spain, 08036 | |
| Hospital de Traumatologia de la Vall d'Hebrón | |
| Barcelona, Spain, 08035 | |
| Hospital Universitari de Bellvitge | |
| Barcelona, Spain, 08907 | |
| Hospital Morales Meseguer | |
| Murcia, Spain, 30008 | |
Sponsors and Collaborators
Ipsen
Investigators
| Principal Investigator: | Harmut Goebel, MD | Kiel Neurological Pain Centre |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00134810 History of Changes |
| Other Study ID Numbers: | Y-47-52120-722 |
| Study First Received: | August 23, 2005 |
| Last Updated: | January 9, 2007 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices United Kingdom: Medicines and Healthcare Products Regulatory Agency Spain: Ministry of Health Poland: Ministry of Health Italy: Ministry of Health Czech Republic: State Institute for Drug Control Portugal: National Pharmacy and Medicines Institute |
Keywords provided by Ipsen:
|
Myofascial pain syndrome |
Additional relevant MeSH terms:
|
Myofascial Pain Syndromes Fibromyalgia Somatoform Disorders Muscular Diseases Musculoskeletal Diseases Rheumatic Diseases Neuromuscular Diseases |
Nervous System Diseases Mental Disorders Botulinum Toxins, Type A Neuromuscular Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013