MedDataX Logo

Calcitonin in the Treatment of Fibromyalgia

NCT ID: NCT00754884

Last Updated: 2015-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fibromyalgia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

200 U.I. of intranasal salmon calcitonin

Group Type EXPERIMENTAL

salmon calcitonin

Intervention Type DRUG

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

B

intranasal saline solution and glycerol

Group Type PLACEBO_COMPARATOR

intranasal saline solution plus glycerol

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

salmon calcitonin

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

Intervention Type DRUG

intranasal saline solution plus glycerol

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Miacalcic nasal spray (Novartis Pharmaceutical) Nasalub

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Unidad de Investigacion en Enfermedades Cronico-Degenerativas

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Cesar Ramos Remus

M.D, Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Cesar R. Ramos-Remus, M.D., MSc

Role: PRINCIPAL_INVESTIGATOR

Attending Rheumatologist HGR45 and Director UIECD

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital General Regional No. 45, IMSS

Guadalajara, Jalisco, Mexico

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Mexico

References

Explore related publications, articles, or registry entries linked to this study.

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

Reference Type BACKGROUND
PMID: 1865419 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2306288 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3549095 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3513074 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10584455 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 12008161 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16575494 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 8832998 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9572636 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UIECD-010

Identifier Type: -

Identifier Source: org_study_id