Calcitonin in the Treatment of Fibromyalgia — CALFI  

Fibromyalgia Clinical Trial

Official title: Phase IV Study of Nasal Salmon Calcitonin in the Treatment of Symptoms and Signs of Fibromyalgia

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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 women and is associated with substantial morbidity and disability. Treatment of fibromyalgia has been disappointing; roughly one-third of patients have had a clinically important therapeutic response to medications or no-medicinal treatment, event with the newest drugs reported in the literature. Pathophysiology of fibromyalgia is unknown, but abnormalities in central neurotransmission might play a role. Some studies have shown that salmon calcitonin increases peripheral and central levels of endorphins. Increasing endorphins levels may decrease pain. Then, it is feasible that nasal administered salmon calcitonin may decrease several of the symptoms and signs of patients suffering fibromyalgia. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

• NCT number: NCT00754884
• Study type: Interventional
• Source: Unidad de Investigacion en Enfermedades Cronico-Degenerativas
• Status: Withdrawn
• Phase: Phase 4
• Start date: October 2008
• Completion date: February 2009