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Calcitonin in the Treatment of Fibromyalgia (CALFI)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Unidad de Investigacion en Enfermedades Cronico-Degenerativas
ClinicalTrials.gov Identifier:
NCT00754884
First received: September 16, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Fibromyalgia
 Drug: salmon calcitonin
Drug: intranasal saline solution plus glycerol
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase IV Study of Nasal Salmon Calcitonin in the Treatment of Symptoms and Signs of Fibromyalgia

Resource links provided by NLM:

MedlinePlus related topics: Fibromyalgia
U.S. FDA Resources

Further study details as provided by Unidad de Investigacion en Enfermedades Cronico-Degenerativas:

Primary Outcome Measures:
  • Functional status as assessed by the Fibromyalgia Impact Questionnaire (FIQ), a self-report inventory developed to measure health status in patients with fibromyalgia [ Time Frame: Day 0, Day 14, Day 28 and Day 56 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health related quality of life as assessed by WHO-DAS II, self-report questionnaire. Dolorimetry will be also used [ Time Frame: Day 0, Day 14, Day 28 and Day 56 ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: October 2008
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
200 U.I. of intranasal salmon calcitonin
 Drug: salmon calcitonin
daily intranasal 200 U.I. salmon calcitonin for periods of 14 days at a time
Other Name: Miacalcic nasal spray (Novartis Pharmaceutical)
Placebo Comparator: B
intranasal saline solution and glycerol
 Drug: intranasal saline solution plus glycerol
daily intranasal (one shot) saline solution plus glycerol for a period of 14 days
Other Name: Nasalub

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00754884

Locations
Mexico
Hospital General Regional No. 45, IMSS
Guadalajara, Jalisco, Mexico, 44290
Sponsors and Collaborators
Unidad de Investigacion en Enfermedades Cronico-Degenerativas
Investigators
Principal Investigator: Cesar R. Ramos-Remus, M.D., MSc Attending Rheumatologist HGR45 and Director UIECD
  More Information

Publications:

Responsible Party: Dr. Cesar Ramos-Remus, Unidad de Investigación en Enfermedades Cronico-Degenerativas
ClinicalTrials.gov Identifier: NCT00754884     History of Changes
Other Study ID Numbers: UIECD-010
Study First Received: September 16, 2008
Last Updated: September 16, 2008
Health Authority: Mexico: National Institute of Public Health, Health Secretariat

Keywords provided by Unidad de Investigacion en Enfermedades Cronico-Degenerativas:
salmon calcitonin
endorphins
treatment
fibromyalgia

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Salmon calcitonin
Calcitonin
Calcitonin Gene-Related Peptide
 Glycerol
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Cryoprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on May 23, 2013