E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10036276 |
E.1.2 | Term | Postoperative analgesia |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
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 |
Efficiency of Sublingual Sufentanil Tablet System (SSTS) which is defined as 75% or more of the treated patients proves NRS less than 4 during 48 hours postoperatively, additionally to the basic pain treatment (paracetamol and NSAID). |
|
E.2.2 | Secondary objectives of the trial |
Safety of the SSTS based on the amount and type of side effects, classified conform NIH criteria (CTCAE) (National institute of health criteria (common terminology criteria for adverse events)) and the risk of causal relationship with the treatment Level of analgesia during physiotherapy.
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Consenting male and female patients between the age of 40 – 75 years, who are admitted for elective total knee arthroplasty, qualify for a fast track rehabilitation program with early mobilization and early hospital discharge, understand the Patient controlled analgesia (PCA) principle and are capable to operate the SSTS device.
|
|
E.4 | Principal exclusion criteria |
- Outside age range - Contra indication for anti-inflammatory drugs - Revision total knee arthroplasty - history of substance abuse, - pregnancy ,lactation - severe hepatic impairment (INR>1,5 and/or AST/ALT above x3 highest normal value), - sleep apnea (documented by sleep laboratory study), - severe chronic kidney disease (eGFR<30 mL/min/1.73 m2), - severe and very severe COPD (GOLD III and IV) - opioid tolerance (use of >15mg oral morphine equivalent per day within the past 3 months), - chronic pain conditions necessitating gabapentinoids, steroids - hypersensitivity to sufentanil - significant respiratory depression (need for outpatient supplemental oxygen therapy), - participation in another clinical trial
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Cumulative/total time when NRS<4 during 48 hours postoperatively. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
During 48 hours postoperatively. |
|
E.5.2 | Secondary end point(s) |
- length of hospital stay - nausea - vomiting - itching - drowsiness - constipation - desaturation - evaluation by health care workers (nurses, physiotherapists) - evaluation by the patient - consumption of study medicadtion during study period for each patient
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
During 48 hours postoperatively. |
|
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 | Yes |
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.8.2.4 | Number of treatment arms in the trial | 1 |
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
|
24 hours after last intake of trial medication. |
|
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 | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |