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Calcitonin in the Treatment of Fibromyalgia (CALFI)

This study has been withdrawn prior to enrollment.
(Study drug was not longer available in our country.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00754884
First Posted: September 18, 2008
Last Update Posted: December 4, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cesar Ramos Remus, Unidad de Investigacion en Enfermedades Cronico-Degenerativas
  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
Intervention Model: Crossover Assignment
Masking: Triple (Participant, 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:


Further study details as provided by Cesar Ramos Remus, 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 ]

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 ]

Enrollment: 0
Study Start Date: October 2008
Study Completion Date: February 2009
Primary Completion Date: February 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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: Cesar Ramos Remus, M.D, Director, Unidad de Investigacion en Enfermedades Cronico-Degenerativas
ClinicalTrials.gov Identifier: NCT00754884     History of Changes
Other Study ID Numbers: UIECD-010
First Submitted: September 16, 2008
First Posted: September 18, 2008
Last Update Posted: December 4, 2015
Last Verified: December 2015

Keywords provided by Cesar Ramos Remus, 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
Pharmaceutical Solutions
Glycerol
Salmon calcitonin
Calcitonin
Calcitonin Gene-Related Peptide
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Vasodilator Agents