Calcitonin in the Treatment of Fibromyalgia (CALFI)

December 3, 2015 updated by: Cesar Ramos Remus, Unidad de Investigacion en Enfermedades Cronico-Degenerativas

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44290
        • Hospital General Regional No. 45, IMSS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Nasalub

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Day 0, Day 14, Day 28 and Day 56

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Day 0, Day 14, Day 28 and Day 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unidad de Investigacion en Enfermedades Cronico-Degenerativas

Investigators

  • Principal Investigator: Cesar R. Ramos-Remus, M.D., MSc, Attending Rheumatologist HGR45 and Director UIECD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

September 16, 2008

First Submitted That Met QC Criteria

September 16, 2008

First Posted (Estimate)

September 18, 2008

Study Record Updates

Last Update Posted (Estimate)

December 4, 2015

Last Update Submitted That Met QC Criteria

December 3, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UIECD-010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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