E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Painful polyneuropathy |
Smertefuld polyneuropati |
|
E.1.1.1 | Medical condition in easily understood language |
Pain due to neuropathy or neuritis |
Nervesmerter forårsaget af polyneuropati |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10054095 |
E.1.2 | Term | Neuropathic pain |
E.1.2 | System Organ Class | 100000004852 |
|
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 |
The objective of the trial is to determine if terbutaline relieves pain in polyneuropathy. |
Formålet med forsøget er at afklare om terbutalin lindrer smerter ved polyneuropati. |
|
E.2.2 | Secondary objectives of the trial |
- to determine if terbutaline is as efficacious in painful polyneuropathy as imipramine
- to determine if terbutaline relieves specific pain symptoms in polyneuropathy
- to determine if terbutaline relieves pain related sleep disturbance in polyneuropathy |
- at undersøge om terbutalin lindrer smerter ved polyneuropati lige så godt som imipramin
- at undersøge om terbutalin lindrer specifikke smertesymptomer ved polyneuropati
- at undersøge om terbutalin har effekt på smerterelateret søvnforstyrrelse ved polyneuropati |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- age over 18 years
- pain due to polyneuropathy for more than 3 months
- pain score 4 or higher on 0-10 point numeric rating scale |
- alder 18 år eller mere
- smerter forårsaget af polyneuropati i mere end 3 måneder
- smerte score 4 eller højere på 0-10 point numerisk skala |
|
E.4 | Principal exclusion criteria |
- other sgnificant pain condition
- other significant neurological or psychiatric disease
- known allergic reactions or other significant adverse events on the study drugs
- significant heart, lung, kidney or liver disease
- treatment with drugs that interact significantly with the study drugs |
- anden betydende smertetilstand
- anden betydende neurologisk eller psykiatrisk sygdom
- kendt allergisk reaktion eller anden betydende bivirkning ved forsøgslægemidlerne
- betydende hjerte-, lunge-, lever- eller nyresygdom
- behandling med lægemidler med betydende interaktion med forsøgslægemidlerne |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary end point wil be numeric rating of total pain on 0-10 point numeric rating scales with daily scores converted to a median for each week. |
Det primære endepunkt vil være score af total smerte på 0-10 point numerisk skala med daglige scores konverteret til en ugentlig median score. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
All weekly score medians from the 5 week treatment periods and the baseline periods will go into the statistical analysis (general linear model). |
Alle ugentlige score medianerfra de 5 ugers behandlingsperioder og baseline perioderne vil indgå i den statistiske analyse (generel lineær model). |
|
E.5.2 | Secondary end point(s) |
- numeric rating 0-10 points of specific pain symptoms
- numeric rating 0-10 points of pain related sleep disturbance
- Patient Global Impression of Change (PGIC) |
- numerisk score 0-10 point af specifikke smertesymprtomer
- numerisk score 0-10 point af smerterelateret søvnforstyrrelse
- patienternes generelle indtryk af ændring (PGIC) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Numeric scores of specific pain symptoms and sleep disturbance as for the primary end point and PGIC after each treatment period. |
Numeriske scores af specifikke smertesymptomer og søvnforstyrrelse som for det primære endepunkt og PGIC efter hver behandlingsperiode. |
|
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 | 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 | 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 | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 6 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
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
|
LVLS |
Sidste patient sidste besøg |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |