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Study drug was not longer available in our country.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | 200 U.I. of intranasal salmon calcitonin |
|
| B | Placebo Comparator | intranasal saline solution and glycerol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| salmon calcitonin | Drug | daily intranasal 200 U.I. salmon calcitonin for periods of 14 days at a time |
|
| Measure | Description | 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 | Day 0, Day 14, Day 28 and Day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cesar R. Ramos-Remus, M.D., MSc | Attending Rheumatologist HGR45 and Director UIECD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General Regional No. 45, IMSS | Guadalajara | Jalisco | 44290 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1865419 | Background | Burckhardt CS, Clark SR, Bennett RM. The fibromyalgia impact questionnaire: development and validation. J Rheumatol. 1991 May;18(5):728-33. | |
| 2306288 | Background | 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. |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| C028815 | salmon calcitonin |
| D005990 | Glycerol |
| ID | Term |
|---|---|
| D000073999 | Triose Sugar Alcohols |
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| intranasal saline solution plus glycerol | Drug | daily intranasal (one shot) saline solution plus glycerol for a period of 14 days |
|
|
| 3549095 | Background | 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. |
| 3513074 | Background | 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. |
| 10584455 | Background | 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. |
| 12008161 | Background | Gennari C. Analgesic effect of calcitonin in osteoporosis. Bone. 2002 May;30(5 Suppl):67S-70S. doi: 10.1016/s8756-3282(02)00713-5. |
| 16575494 | Background | 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. |
| 8832998 | Background | Wolfe F. The fibromyalgia syndrome: a consensus report on fibromyalgia and disability. J Rheumatol. 1996 Mar;23(3):534-9. No abstract available. |
| 9572636 | Background | 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. |
| D009422 |
| Nervous System Diseases |
| D002241 |
| Carbohydrates |