E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic idiopathic pain syndromes (fibromyalgia, myofascial pain, complex regional pain syndrome) |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10033371 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
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. |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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 |
|
E.4 | Principal 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 |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Decrease of the mean pain level (VAS) at day 14 in comparison to the level at study start (group A). |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Last patient, last visit. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 7 |