Status:
WITHDRAWN
Calcitonin in the Treatment of Fibromyalgia
Lead Sponsor:
Unidad de Investigacion en Enfermedades Cronico-Degenerativas
Conditions:
Fibromyalgia
Eligibility:
FEMALE
18-50 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine whether nasal administration of salmon calcitonin is effective and safe in the treatment of symptoms and signs of primary fibromyalgia.
Detailed Description
Fibromyalgia is a common, chronic musculoskeletal disorder that is characterized by widespread pain and tenderness. Fibromyalgia occurs in around 2% of the US general population, is more common in wom...
Eligibility Criteria
Inclusion
- Female patients between 18 and 50 years
- Fibromyalgia diagnosis (ACR criteria)
- Must be able to apply the nasal medication
- Must be able to comply with study visits
- Must be able to understand informed consent
- Must be able to answer self-administered questionnaires
- Must have an active disease(VAS \> 60mm)
Exclusion
- Comorbid conditions (i.e. hypothyroidism, diabetes mellitus, etc.)
- Any disturbance in the nasal tissue
- Use of concomitant opioid analgesics
- Contraindication to use salmon calcitonin (allergy, hypocalcemia, hypophosphatemia)
- Other rheumatic diseases
- Diagnosis of major depressive disorder
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00754884
Start Date
October 1 2008
End Date
February 1 2009
Last Update
December 4 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital General Regional No. 45, IMSS
Guadalajara, Jalisco, Mexico, 44290