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.

• Conditions: Chronic idiopathic pain syndromes (fibromyalgia, myofascial pain, complex regional pain syndrome); MedDRA version: 8.1Level: PTClassification code 10033371

• Registration Number: EUCTR2005-004918-32-DE
• Lead Sponsor: Biotest AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-06
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.