STUDY ON THE CONTROL OF PAIN SYNTOMS AND SIDE EFFECTS THOUGH THE USE OF PHARMACOLOGY ASSOSATION OF OXICODONE/NALOXONE IN MODERATE TO SEVERE POST OPERATIVE PAIN

MANAGMENT OF PATIENT WITH MODERATE TO SEVERE POSTOPERATIVE PAIN AFTER SURGERY FOR HYSTERECTOMY: BLIND, RANDOMZATED, CONTROLLATED EXPERIMENTAL STUDY ON THE CONTROL OF PAIN SYNTOMS AND SIDE EFFECTS THOUGH THE USE OF PHARMACOLOGY ASSOSATION OF OXICODONE/NALOXONE PR 10/5 MG CP IN CLINICAL PRACTICE - OSSICODONE/NALOXONE 2014

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-005521-12-IT

Enrollment

141

Registered

2019-03-18

Start date

2015-10-26

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

POSTOPERATIVE PAIN AFTER HYSTERECTOMY MedDRA version: 20.1 Level: LLT Classification code 10054711 Term: Postoperative pain System Organ Class: 100000004863

Interventions

Trade Name: TARGIN - "10 MG/5 MG COMPRESSE A RILASCIO PROLUNGATO" 100 COMPRESSE IN FLACONE HDPE Product Name: TARGIN Pharmaceutical Form: Prolonged-release tablet INN or Proposed INN: OSSICODONE CLORI

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: FEMALE; AGE >18; HYSTERECTOMY Are the trial subjects under 18? no Number of subjects for this age range: 1 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 141 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: AGE 3; OPPIOIDE ALLERGY; HOME TERAPY WITH ANALGESIC; CRONIC PAIN

Design outcomes

Primary

Measure	Time frame
Main Objective: DRUG SIDE EFFECTS;Secondary Objective: ANALGESIA NRS<4 AND REDUCTION OF RECOVERY DAYS;Primary end point(s): OBD REDUCTION OF 50%;Timepoint(s) of evaluation of this end point: 48 H	—

Secondary

Measure	Time frame
Secondary end point(s): AVARAGE NRS >4;Timepoint(s) of evaluation of this end point: 48H	—

Countries

Italy

Contacts

Public ContactU.O.C. ANESTESIA E RIANIMAZIONE PED

FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO

laura.landi@email.it0255032584

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026