NCT00754884

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2008

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 18, 2008

Completed
13 days until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

December 4, 2015

Status Verified

December 1, 2015

Enrollment Period

4 months

First QC Date

September 16, 2008

Last Update Submit

December 3, 2015

Conditions

Fibromyalgia

Keywords

salmon calcitoninendorphinstreatmentfibromyalgia

Outcome Measures

Primary Outcomes (1)

  • Functional status as assessed by the Fibromyalgia Impact Questionnaire (FIQ), a self-report inventory developed to measure health status in patients with fibromyalgia

    Day 0, Day 14, Day 28 and Day 56

Secondary Outcomes (1)

  • Health related quality of life as assessed by WHO-DAS II, self-report questionnaire. Dolorimetry will be also used

    Day 0, Day 14, Day 28 and Day 56

Study Arms (2)

A

EXPERIMENTAL

200 U.I. of intranasal salmon calcitonin

Drug: salmon calcitonin

B

PLACEBO COMPARATOR

intranasal saline solution and glycerol

Drug: intranasal saline solution plus glycerol

Interventions

salmon calcitoninDRUG

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

Also known as: Miacalcic nasal spray (Novartis Pharmaceutical)
A
intranasal saline solution plus glycerolDRUG

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

Also known as: Nasalub
B

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital General Regional No. 45, IMSS

Guadalajara, Jalisco, 44290, Mexico

Location

Related Publications (9)

  • Burckhardt CS, Clark SR, Bennett RM. The fibromyalgia impact questionnaire: development and validation. J Rheumatol. 1991 May;18(5):728-33.

    PMID: 1865419BACKGROUND

  • Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, Tugwell P, Campbell SM, Abeles M, Clark P, et al. The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia. Report of the Multicenter Criteria Committee. Arthritis Rheum. 1990 Feb;33(2):160-72. doi: 10.1002/art.1780330203.

    PMID: 2306288BACKGROUND

  • MacIntyre I, Alevizaki M, Bevis PJ, Zaidi M. Calcitonin and the peptides from the calcitonin gene. Clin Orthop Relat Res. 1987 Apr;(217):45-55.

    PMID: 3549095BACKGROUND

  • Szanto J, Jozsef S, Rado J, Juhos E, Hindy I, Eckhardt S. Pain killing with calcitonin in patients with malignant tumours. Oncology. 1986;43(2):69-72. doi: 10.1159/000226336.

    PMID: 3513074BACKGROUND

  • Mystakidou K, Befon S, Hondros K, Kouskouni E, Vlahos L. Continuous subcutaneous administration of high-dose salmon calcitonin in bone metastasis: pain control and beta-endorphin plasma levels. J Pain Symptom Manage. 1999 Nov;18(5):323-30. doi: 10.1016/s0885-3924(99)00081-0.

    PMID: 10584455BACKGROUND

  • Gennari C. Analgesic effect of calcitonin in osteoporosis. Bone. 2002 May;30(5 Suppl):67S-70S. doi: 10.1016/s8756-3282(02)00713-5.

    PMID: 12008161BACKGROUND

  • Ofluoglu D, Akyuz G, Unay O, Kayhan O. The effect of calcitonin on beta-endorphin levels in postmenopausal osteoporotic patients with back pain. Clin Rheumatol. 2007 Jan;26(1):44-9. doi: 10.1007/s10067-006-0228-z. Epub 2006 Mar 31.

    PMID: 16575494BACKGROUND

  • Wolfe F. The fibromyalgia syndrome: a consensus report on fibromyalgia and disability. J Rheumatol. 1996 Mar;23(3):534-9. No abstract available.

    PMID: 8832998BACKGROUND

  • Bessette L, Carette S, Fossel AH, Lew RA. A placebo controlled crossover trial of subcutaneous salmon calcitonin in the treatment of patients with fibromyalgia. Scand J Rheumatol. 1998;27(2):112-6. doi: 10.1080/030097498440976.

    PMID: 9572636BACKGROUND

MeSH Terms

Conditions

Fibromyalgia

Interventions

salmon calcitoninGlycerol

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Triose Sugar AlcoholsSugar AlcoholsAlcoholsOrganic ChemicalsCarbohydrates

Study Officials

  • Cesar R. Ramos-Remus, M.D., MSc

    Attending Rheumatologist HGR45 and Director UIECD

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D, Director

Study Record Dates

First Submitted

September 16, 2008

First Posted

September 18, 2008

Study Start

October 1, 2008

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

December 4, 2015

Record last verified: 2015-12

Locations

ME(1)