E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
acute post-operative peripheral neuropathic pain |
|
E.1.1.1 | Medical condition in easily understood language |
acute post-operative peripheral neuropathic pain |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
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 |
• Investigate the effect of adding pregabalin to the current standard pain treatment for patients with acute NeP. • To characterize the development of acute neuropathic pain in the patients included in the study.
|
|
E.2.2 | Secondary objectives of the trial |
• Investigate whether adding pregabalin will reduce the need for opioids in patients with acute NeP. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age: Participant must be 18 years of age inclusive, at the time of signing the informed consent. Type of Participant and Disease Characteristics: Patients that have verified NeP following surgery and are identified and included within 7 days after nerve injury
Informed Consent: Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
|
|
E.4 | Principal exclusion criteria |
Participants are excluded from the study if any of the following criteria apply:
Medical Conditions: 1. Psychiatric disease 2. Renal failure (GFR <60) 3. Patients that are cognitively impaired 4. Daily substance abuse (drugs/alchohol) 5. Pregnancy
Prior/Concomitant Therapy: 1. Patients that use current 1st line NeP-medication at admission, regardless of indication. This includes Lyrica, gabapentin, SNRI and Tricyclic antidepressiva.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
• Pain intensity measured using Numeric Rating Scale (NRS), measured 3 times/day (actual pain) ((at 09:00 hrs (+/- 1 h), 15:00 hrs (+/-1h) and 21:00 hrs(+/- 1h)) during the first 2 weeks and then 1 time/week (usual pain for the last 7 days recorded each Monday at 12:00 hrs (+/- 1h)) during the following 10 weeks. NRS will be recorded for both rest and activity. • As this a pilot study, we will describe each individual patient in detail with regards to how long and how intense the pain is rated during the observation period. The number of included patients will probably not be sufficient to produce results of statistical significance between the pregabalin group and the control group. However, the detailed history of each patient will give new insight which will serve as a basis for later possible RCTs. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
• Opioid use during the study period using oral morphine equivalents (OMEQ) as measurement. Opioid use will be assessed and recorded at the follow-up visit. . |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
follow-up visit, after end of study |
|
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 | Yes |
E.8.1.1 | Randomised | Yes |
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 | 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) | Yes |
E.8.2.2 | Placebo | No |
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
|
|
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 | 6 |
E.8.9.1 | In the Member State concerned days | |