FibromyalgiaPhase 4CALFINCT00754884
Calcitonin in the Treatment of Fibromyalgia
A Phase 4 study testing salmon calcitonin and intranasal saline solution plus glycerol in people with Fibromyalgia, run by Unidad de Investigacion en Enfermedades Cronico-Degenerativas at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- salmon calcitonin and intranasal saline solution plus glycerol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteMexico
- Study dates
- Oct 2008to Feb 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital General Regional No. 45, IMSS
Guadalajara, Jalisco, 44290
About this study
Official title: 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.
Read the 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.
- Conditions
- Fibromyalgia
- Being tested
- salmon calcitonin, intranasal saline solution plus glycerol
- Keywords
- salmon calcitonin, endorphins, treatment, fibromyalgia
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
salmon calcitoninDrug
Also called Miacalcic nasal spray (Novartis Pharmaceutical)
daily intranasal 200 U.I. salmon calcitonin for periods of 14 days at a time
intranasal saline solution plus glycerolDrug
Also called Nasalub
daily intranasal (one shot) saline solution plus glycerol for a period of 14 days
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | 200 U.I. of intranasal salmon calcitonin Receives: Drug: salmon calcitonin |
| B | Placebo comparator | intranasal saline solution and glycerol Receives: Drug: intranasal saline solution plus glycerol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional status as assessed by the Fibromyalgia Impact Questionnaire (FIQ), a self-report inventory developed to measure health status in patients with fibromyalgia
Measured: 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
Measured: Day 0, Day 14, Day 28 and Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2008 (estimated)
- Study startOct 2008
- Primary completionFeb 2009
- Study completionFeb 2009
Why it stopped: Study drug was not longer available in our country.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unidad de Investigacion en Enfermedades Cronico-Degenerativas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cesar Ramos Remus, Unidad de Investigacion en Enfermedades Cronico-Degenerativas
- Investigators
- Cesar R. Ramos-Remus, M.D., MSc, Principal investigator, Attending Rheumatologist HGR45 and Director UIECD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00754884
- Sponsor's protocol ID
- UIECD-010
- Acronym
- CALFI
- Status last verified
- Dec 2015
- First submitted
- 16 Sep 2008
- Last updated
- 4 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Burckhardt CS, Clark SR, Bennett RM. The fibromyalgia impact questionnaire: development and validation. J Rheumatol. 1991 May;18(5):728-33.
PubMed 1865419Wolfe 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.
PubMed 2306288MacIntyre I, Alevizaki M, Bevis PJ, Zaidi M. Calcitonin and the peptides from the calcitonin gene. Clin Orthop Relat Res. 1987 Apr;(217):45-55.
PubMed 3549095Szanto 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.
PubMed 3513074Mystakidou 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.
PubMed 10584455Gennari C. Analgesic effect of calcitonin in osteoporosis. Bone. 2002 May;30(5 Suppl):67S-70S. doi: 10.1016/s8756-3282(02)00713-5.
PubMed 12008161Ofluoglu 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.
PubMed 16575494Wolfe F. The fibromyalgia syndrome: a consensus report on fibromyalgia and disability. J Rheumatol. 1996 Mar;23(3):534-9. No abstract available.
PubMed 8832998Bessette 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.
PubMed 9572636
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study of Nasal Salmon Calcitonin in the Treatment of Symptoms and Signs of Fibromyalgia
- ClinicalTrials.gov ID
- NCT00754884
- Acronym / sponsor ID
- CALFI / UIECD-010
- Conditions
- Fibromyalgia
- Keywords
- salmon calcitonin, endorphins, treatment, fibromyalgia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study drug was not longer available in our country.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Unidad de Investigacion en Enfermedades Cronico-DegenerativasUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 18 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: salmon calcitonin200 U.I. of intranasal salmon calcitonin |
| B | Placebo comparator | Drug: intranasal saline solution plus glycerolintranasal saline solution and glycerol |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| salmon calcitoninAlso: Miacalcic nasal spray (Novartis Pharmaceutical)daily intranasal 200 U.I. salmon calcitonin for periods of 14 days at a time | Drug | A |
| intranasal saline solution plus glycerolAlso: Nasalubdaily intranasal (one shot) saline solution plus glycerol for a period of 14 days | Drug | B |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2015.
- Background: PubMed 1865419Burckhardt CS, Clark SR, Bennett RM. The fibromyalgia impact questionnaire: development and validation. J Rheumatol. 1991 May;18(5):728-33.
- Background: PubMed 2306288Wolfe 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.
- Background: PubMed 3549095MacIntyre I, Alevizaki M, Bevis PJ, Zaidi M. Calcitonin and the peptides from the calcitonin gene. Clin Orthop Relat Res. 1987 Apr;(217):45-55.
- Background: PubMed 3513074Szanto 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.
- Background: PubMed 10584455Mystakidou 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.
- Background: PubMed 12008161Gennari C. Analgesic effect of calcitonin in osteoporosis. Bone. 2002 May;30(5 Suppl):67S-70S. doi: 10.1016/s8756-3282(02)00713-5.
- Background: PubMed 16575494Ofluoglu 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.
- Background: PubMed 8832998Wolfe F. The fibromyalgia syndrome: a consensus report on fibromyalgia and disability. J Rheumatol. 1996 Mar;23(3):534-9. No abstract available.
- Background: PubMed 9572636Bessette 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cesar R. Ramos-Remus, M.D., MSc principal investigator
Attending Rheumatologist HGR45 and Director UIECD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing salmon calcitonin and intranasal saline solution plus glycerol in people with Fibromyalgia, run by Unidad de Investigacion en Enfermedades Cronico-Degenerativas at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00754884, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2015.