Trial | NCT00754884  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Withdrawn

  • Intervention/Treatment

    calcitonin salmon ...

  • Study Participants

    0
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.
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 Started
Oct 31
2008
Primary Completion
Feb 28
2009
Study Completion
Feb 28
2009
Last Update
Dec 04
2015
Estimate

Drug salmon calcitonin

daily intranasal 200 U.I. salmon calcitonin for periods of 14 days at a time

  • Other names: Miacalcic nasal spray (Novartis Pharmaceutical)

Drug intranasal saline solution plus glycerol

daily intranasal (one shot) saline solution plus glycerol for a period of 14 days

  • Other names: Nasalub

A Experimental

200 U.I. of intranasal salmon calcitonin

B Placebo Comparator

intranasal saline solution and glycerol

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
No Results Posted