Calcitonin in the Treatment of Fibromyalgia

• Status: Withdrawn
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Unidad de Investigacion en Enfermedades Cronico-Degenerativas
• Treatments: Calcitonin; Calcitonin Gene-Related Peptide; Glycerol; Katacalcin; Pharmaceutical Solutions; Salmon calcitonin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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