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Trial · Interventional

WithdrawnPhase 4Registry data

Calcitonin in the Treatment of Fibromyalgia

Short name CALFI

NCTNCT00754884 (opens ClinicalTrials.gov in a new tab)Other idUIECD-010
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Withdrawn
Phase
Phase 4
Enrollment
0 participants (actual)
Sponsor
Unidad de Investigacion en Enfermedades Cronico-Degenerativas · Other
Design
Randomized · Triple masking
Countries
1 country

Mexico

Start
Oct 2008
Primary completion
Feb 2009
Completion
Feb 2009
First posted
18 Sept 2008 (estimated)
Last update posted
4 Dec 2015 (estimated)
Conditions
Fibromyalgia

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200820092010
  1. Ph 4

    CALFI

    NCT00754884

    Oct 2008 to Feb 2009

    Withdrawn

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • salmon calcitoninDrug
  • intranasal saline solution plus glycerolDrug

Arms2

  • Experimental

    A

    200 U.I. of intranasal salmon calcitonin

  • Placebo comparator

    B

    intranasal saline solution and glycerol

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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 outcomes(1)

  1. 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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies3

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2007

3 results

The effect of calcitonin on beta-endorphin levels in postmenopausal osteoporotic patients with back pain.

Ofluoglu et al. 2007Clinical rheumatologycited by 27

PMID 16575494DOI 10.1007/s10067-006-0228-zPUB-16575494

Full text at the publisher3 results
Publisher pageSee results (3)

Indexing hint: Randomized controlled trial · 1998

3 results

A placebo controlled crossover trial of subcutaneous salmon calcitonin in the treatment of patients with fibromyalgia.

Bessette et al. 1998Scandinavian journal of rheumatologycited by 14

PMID 9572636DOI 10.1080/030097498440976PUB-09572636

Full text at the publisher3 results
Publisher pageSee results (3)

More studies

1 study on this page

Indexing hint: Clinical trial · 1999

Continuous subcutaneous administration of high-dose salmon calcitonin in bone metastasis: pain control and beta-endorphin plasma levels.

Mystakidou et al. 1999Journal of pain and symptom managementcited by 16

PMID 10584455DOI 10.1016/s0885-3924(99)00081-0PUB-10584455

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 50 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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