E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Not possible to specify |
MedDRA Classification |
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 |
To evaluate if fibromyalgia patients who get Mekobalamin (Vitamin B12) injections once a week can reduce their pain sensitivity compared to placebo. |
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E.2.2 | Secondary objectives of the trial |
To evaluate if patients who get vitamin B12-injections can: *reduce their pain intensity *obtain a higher level of activity and a better quality of Life * the study drug's effect *safety of the study drug *how patients describe their pain, health, sufferness and well-being *Also to evaluate how patients with fibromyalgia experience to live with long-term pain
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
*Swedish speaking women between 20-70 years *Diagnosed with fibromyalgia *Conscent to the trial * Use a safe birth control method such as birth control pills, p-rod, p-syringe, p-patch, hormone coil, copper coil *-Renal function value GFR >60 mL/min/1,73 m2 *Liver function value: P-ALP 0,6-2,85 µkat/L P-ALAT 0,15-1,13 µkat/L *Cardiac function value Troponin-T < 15 ng/L NT-pro-BNP >125 <450 <50 years NT-pro-BNP >300 <900 50-75 years *Kobalamin >250 pmol/L < 800 pmol/L
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E.4 | Principal exclusion criteria |
*use of neuroleptics (antipsychotic treatment) *have Reynaud's phenomenon (white finger) * neuropathi (numbness) *vegan *previous treatment with Vitamin B12 *cardiac, hepatic or renal impairment *hypersensitivity to the active substance or any of the excipients *pregnant or planning to become pregnant *breast feeding
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E.5 End points |
E.5.1 | Primary end point(s) |
Tolerance time(seconds) the subjects has his hand in the cold water bath using the Cold Pressure Test. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
12 weeks and 24 weeks after first injection compared to before treatment start. |
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E.5.2 | Secondary end point(s) |
Pain measured by NRS 0-100. Score at questionaire: RAND-36 and MPQ Effect of treatment measured by PGIC |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
12 weeks and 24 weeks after first injection compared to before treatment start. |
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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 | No |
E.6.5 | Efficacy | No |
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 | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | No |
E.8.7 | Trial has a data monitoring committee | No |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |