post-operative pain following abdominal hysterectomy
Conditions
Interventions
Product Name: E-52862
Pharmaceutical Form: Capsule
INN or Proposed INN: -
CAS Number: 878141-96-9
Current Sponsor code: E-52862
Other descriptive name: E-52862.HCl
Concentration unit: mg milligram(s)
Sponsors
Laboratorios Dr. Esteve S.A. (ESTEVE)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Female patients aged between 18 and 80 years 2)Patients scheduled for an elective non-malignant partial or total abdominal hysterectomy under general anaesthesia (patients with cervix or endometrial carcinoma stage 1 can be also included) 3)Patients who provide a signed informed consent prior to study entry 4)Patients with ASA physical status I to III 5)Patients with preoperative tests previous to the start of treatment Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1)Patients with other pain that may interfere the assessments of the study 2)Hypersensitivity or allergy to the investigational medicinal product (IMP), to chemically related products or to placebo. 3)History of alcohol or substance abuse 4)Uncontrolled chronic disease or a concurrent clinical illness or medical condition that would contraindicate the study participation or confound the interpretation of the results upon the investigator?s opinion 5)Female with a Body Mass Index (BMI) >35 kg/m2 6)Patients that will undergo an epidural anaesthesia and nerve block 7)Patients that have used an investigational drug within 30 days prior to administration of the study medication. 8)Patients with chronic opioids use or that have been exposed to them during the last month under a continuous regimen 9)Patients who are unable to cooperate / understand the procedure of the patient-controlled analgesia (PCA) system 10)Patients taking prohibited medications 11)Patients with the following laboratory values abnormalities: a)ALT, AST and GGT > 2x ULN b)Neutrophils 1.25 X ULN g)Creatinine: >1.25 x ULN h)Any other laboratory abnormality that is judged by the investigator to be clinically relevant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess the analgesic effect of E-52862 compared to placebo on pain following hysterectomy, measured through the morphine consumption administered by Patient Controlled Analgesia (PCA) during the first 24 post-operative hours, pain at rest and movement-evoked pain.;Secondary Objective: To describe the profile of adverse effects of E-52862 in patients undergoing abdominal histerectomy when administered together with and anesthetic regimen and opioids. To ensure E-52862 plasma exposure associated with a pharmacodynamic response after administration of repeated oral doses for 3 days in patients undergoing abdominal histerectomy. Open label extension sub-study: ?To evaluate the incidence of neuropathic pain at 0, 3 and 6 months ?To evaluate the quality of life (QoL) at 0, 3 and 6 months;Primary end point(s): The primary endpoint will be total morphine consumption in mg administered by PCA during the 24 hours post-operative period.;Timepoint(s) of evaluation of this end point: during the 24 hours post-operative period | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1_Total morphine consumption in mg administered by PCA during the 48 hours post-operative period and during the 24 to 48 hours period 2_Total morphine consumption in mg administered by PCA plus subcutaneous injection during the 24 and 48 hours post-operative period and during the 24 to 48 hours period. 3_Pain intensity (at rest and movement-evoked) during the first 24 and 48 hours after the end of surgery 4_Pain intensity (at rest and movement-evoked) during the first 9 days post surgery 5_Time to first PCA administration 6_Consumption and time to first consumption of pain rescue medication 7_The patients global treatment assessment and patients satisfaction 8_Pharmacokinetics: Assessment of plasma concentrations at different time points of E-52862 (and morphine and metabolites when deemed necessary). Also, the following pharmacokinetic parameters will be calculated when possible: tmax, Cmax and AUC0-t. 9_Safety: the number, intensity and causality of adverse events will be compared between treatment groups; adverse events will include clinical abnormalities, vital signs, laboratory abnormalities or ECG abnormalities, as well as any additional finding that may be regarded as an adverse event.;Timepoint(s) of evaluation of this end point: 1_during the 48 hours post-operative period and during the 24 to 48 hours period 2_during the 24 and 48 hours post-operative period and during the 24 to 48 hours period. 3_during the first 24 and 48 hours after the end of surgery 4_during the first 9 days post surgery 5_Time to first PCA administration 6_time to first consumption of pain rescue medication 8_at different time points of E-52862 (and morphine and metabolites when deemed necessary). Also, the following pharmacokinetic parameters will be calculated when possible: tmax, Cmax and AUC0-t. | — |
Countries
Spain
Contacts
Public ContactSusana Carner
Trial Form Support
Outcome results
None listed