A monocentre, open-label, prospective study investigating the effects of the human normal immunoglobulin Intratect®/ BT 681 for intravenous administration on clinical efficacy, safety, and laboratory parameters in patients with chronic idiopathic pain syndromes.

Biotest AG0 个研究点开始时间: 2006年1月6日最近更新: 2014年1月27日

适应症

试验速览

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•Group A and B:
•male or female patients (age 18 - 75 years)
•written informed consent (signed by patient and investigator)
•chronic idiopathic pain syndromes such as fibromyalgia, myofascial pain
•syndrome, complex regional pain syndrome according to clinical classification
•absence of satisfactory effects after analgetic and co-analgetic pharmacotherapy
•in tolerable dosages, as listed in the following for the specific indications:
•Fibromyalgia*: GLOA, flupirtin, ibuprofen, acetylsalicylicacid, naproxen, novalgin, tolperison, amitryptilin, doxepin, clomipramin, nortriptylin, opioids (oxycodon, tramadol, tilidin), spironolacton.
•Myofascial pain*: GLOA, flupirtin, ibuprofen, tolperison, amitryptilin, doxepin, clomipramin, nortriptylin, opioids (oxycodon, tramadol, tilidin), spironolacton.
•Complex regional pain syndrome*: GLOA, gabapentin, topiramat, IVRSB-G, biphosphonates, prednisolone, metamizole, amitryptilin, desipramin, maprotilin, calcitonin.
•*For definitions, please refer to Appendix 20.6 in the study protocol.
•no or only acute pain before surgery of the urogenital tract or of the lower
•extremities and decision taken to have spinal anaesthesia
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Group A and B:
•pregnancy or unreliable contraceptive measures or lactation period (women only)
•participation in another clinical trial within 90 days before entering the study or
•during the study and/or previous participation in this study
•inability or lacking motivation to participate in the study
•anamnestically known intolerance to immunoglobulins or comparable substances
•(e.g. vaccination reaction)
•anamnestically known intolerance to proteins of human origin
•selective, absolute IgA deficiency
•anamnestic signs for a thrombophile haemostasis disorder
•anamnestically known diagnosis of hepatitis B and hepatitis C
•anamnestically known diagnosis of positive HIV test
•acute viral and bacterial infections
•pre-treatment with immunoglobulins
•any kind of chronic pain syndromes in anamnesis
•anamnestic signs for acute or chronic infections

发起方