E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Neuropathic pain |
Hermovauriokipu |
|
E.1.1.1 | Medical condition in easily understood language |
Pain due to nerve injury |
Hermovauriokipu |
|
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 | 21.0 |
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.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10067547 |
E.1.2 | Term | Diabetic peripheral neuropathic pain |
E.1.2 | System Organ Class | 100000004852 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10077974 |
E.1.2 | Term | Peripheral 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 |
To study the effects or pregabalin in neuropathic pain and sleep. The question is: does pregabalin provide better relief in patients who have a relevant sleep problem in addition to neuropathic pain compared with those who do not have a sleep problem. |
Tutkimme pregabaliinin vaikutusta hermovauriokipuun ja uneen. Kysymys on: tehoaako pregabaliini paremmin potilailla, joilla on hermovauriokivun isäksi unihäiriö kuin niillä, joilla sitä ei ole. |
|
E.2.2 | Secondary objectives of the trial |
What is the effect of pregabalin on the sleep structure of patients who have neuropathic pain |
Miten pregabaliini vaikuttaa hermovauriokipupotilaiden unen rakenteeseen |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age: 18-75 yrs, neuropathic pain for >3 months, numerical rating scale intensity for pain 5 or more on a 10 point scale, sleep disturbance >14 in 50% of the patients |
Ikä: 18-75 v, hermovaurikivun kesto yli 3 kk, kivun voimakkkuus vähintää 5/10 asteikolla 0-10 ja 50%:lla potilaista unihäiriö (ISI>14) |
|
E.4 | Principal exclusion criteria |
Major psychiatric condition, inability to fill in the questionnaires in Finnish, drugs that affect sleep |
Merkittävä psykiatrinen sairaus, kyvyttömyys täyttää lomakkeita suomeksi, lääkkeet, jotka vaikuttavat uneen |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Mean pain interference during the previous week as assessed when the drug has been on a stable dose for a month, compared with baseline |
Edeltäneen viikon keskimääräisen kivun häiritsevyyden muutos lääkkeen oltua vakaalla annoksella kuukauden ajan verrattuna ennen lääkitystä olleeseen tilanteesen |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
The week before treatment is started vs. the last week once the treatment has been on a stable dose for a month |
Viikko ennen lääkityksen aloitusta vs. viimeinen viikko lääkityksen oltua kuukauden vakaalla tasolla |
|
E.5.2 | Secondary end point(s) |
Sleep on the ISI questionnaire during the previous week as assessed when the drug has been on a stable dose for a month, compared with baseline |
Uni ISI-lomakkeen mukaisesti viikko ennen lääkityksen aloitusta vs. viimeinen viikko lääkityksen oltua kukauden vakaalla tasolla |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
The week before treatment is started vs. the last week once the treatment has been on a stable dose for a month |
Viikko ennen lääkityksen aloitusta vs. viimeinen viikko lääkityksen oltua kuukauden vakaalla tasolla |
|
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 | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
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
| 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 | 2 |
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 |
Viimeisen tutkimuspotilaan viimeinen tutkimuskäynti |
|
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 | |
E.8.9.1 | In the Member State concerned days | |