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 | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
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 assess the short -term efficacy of stellate ganglion block on hot flush reduction versus sham procedure |
Het effect van stellatum-ganglion blokkade op ernstige opvliegers bij post-menopauzale vrouwen (al dan niet ten gevolge van borstkanker behandeling) vergelijken met een sham-procedure |
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E.2.2 | Secondary objectives of the trial |
To assess the eficacy of stellate ganglion block on quality of life |
Het effect van stellatum-ganglion blokkade op kwaliteit van leven |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Female
age 30-70
mean daily flush frequency >9
hot flush score >14
absence of reasons for flushing other than post-menopauzal |
vrouwen
leeftijd 30-70 jaar
minimaal 10 opvliegers per dag
dagelijkste hot flush score van meer dan 15
geen andere reden voor opvliegers buiten postmenopauzaal |
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E.4 | Principal exclusion criteria |
- Use of medication that affects flushing:
estrogens, progestogens, clonidine, naloxone, paroxetine, fluodxetine, venlaflaxine, gabapentin, LHRH receptor antagonist
-Still receiving chemotherapy of radiotherapy
-Psychiatric disease
-Any unstable concurrent disease |
- Medicatie gebruik welke invloed kunnen hebben op opvliegers:
estrogens, progestogens, clonidine, naloxone, paroxetine, fluoxetine, venlaflaxine, gabapentin, LHRH receptor antagonis
-gelijktijdige behandeling met chemotherapie
-Psychiatric disease
-Any unstable concurent disease |
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E.5 End points |
E.5.1 | Primary end point(s) |
Hot flush socre: percentage reduction in hot flush score and the numer of subjects reaching a flush score reduction > 50%
Hot Flush score = mean daily flush frequency x flush severity
(flush severity = mean severity score of every flush on a 1-4 scale) |
Afname in Hot Flush score (middels dagboek score =frequentie*ernst van opvlieger) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
week 2, week 4, week 8, week 12 and week 26 |
week 2, week 4, week 8, week 12 en week 26 |
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E.5.2 | Secondary end point(s) |
Quality of life, measured with 3 questionnaires
a. Hot Flash-Related Daily Interference Scale (HFRDIS)
b. Epwordth Sleepiness Scale (ESS)
c. PSQL (Pittsburgh Sleep Quality Index)
d. MENQOL (Menopause-Specific Quality of LIfe)
e CES-D (Center for Epidemiologic Studies Depression Scale |
3 kwaliteit van leven/slapen vragenlijsten (HFRDIS, ESS en PSQI, MENQOL, CES-D) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
week 2, week 4, week 8, week 12 and week 26 |
week 2, week 4, week 8, week 12 en week 26 |
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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) | 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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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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Lvls |
laatste visite laatste proefpersoon |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |