Chronic idiopathic pain syndromes (fibromyalgia, myofascial pain, complex regional pain syndrome) MedDRA version: 8.1 Level: PT Classification code 10033371
Conditions
Interventions
Product Name: Intratect®
Product Code: BT 681
Pharmaceutical Form: Solution for infusion
Current Sponsor code: BT 681/ Intratect®
Other descriptive name: Human normal immunoglobulin (IVIG)
Concentrati
Sponsors
Biotest AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Group A and B: • male or female patients (age 18 - 75 years) • written informed consent (signed by patient and investigator) Group A: • VAS = 4 • PDI = 35 • chronic idiopathic pain syndromes such as fibromyalgia, myofascial pain syndrome, complex regional pain syndrome according to clinical classification criteria • 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. Group B: • 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
Exclusion criteria
Exclusion criteria: 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 Group A: • 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 Group B: • any kind of chronic pain syndromes in anamnesis • anamnestic signs for acute or chronic infections
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Comparison of pro-inflammatory and neuroendocrine factors in serum and spinal fluid of patients with chronic pain compared to patients with no or only acute pain.;Primary end point(s): Decrease of the mean pain level (VAS) at day 14 in comparison to the level at study start (group A).;Main Objective: Main objective of this phase III study is to investigate the effects on efficacy, safety and laboratory parameters of the human normal intravenous immunoglobulin Intratect®/BT681 in patients with chronic idiopathic pain syndromes, such as fibromyalgia, myofascial pain and complex regional pain syndrome. | — |
Countries
Germany
Outcome results
None listed