Analgesic and anti-inflammatory action after gynecological surgical procedures MedDRA version: 20.0 Level: PT Classification code 10053467 Term: Antiinflammatory therapy System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 20.0 Level: PT Classification code 10036276 Term: Postoperative analgesia System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Algofren® 400 mg film-coated tablets
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: IBUPROFEN
CAS Number: 15687-27-1
Concentration unit: mg milligram(s)
Concentration type: e
Sponsors
Ioulia and Irene Tseti Pharmaceutical Laboratories S.A., d.t. "Intermed S.A."
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Study population: 150 female patients (18-83 years old) who after signing inform consent form they will undergo one of the following surgical procedures: - Anterior colporraphy - Posterior colporraphy - Vaginal hysterectomy - Perineorraphy - Abdominal hysterectomy - Fibroid removal - Laparoscopic procedures Vaginal swabs will be obtained pre and post operatively for estimation of inflammation markers. 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 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 150
Exclusion criteria
Exclusion criteria: Patients younger than 18 and older than 83 years old, history of allergy or intolerance to ibuprofen or NSAIDs, history ulceration and/or gastrointestinal haemorrhage (2 or more different episodes), severe heart failure, not well controlled hypertension (fluid retention and oedema have been reported with NSAIDs treatment), pregnancy and breastfeeding, concomitant administration of COX-2 inhibitors, medication that may increase the risk of ulceration and haemorrhage such as steroids, anticoagulants e.g. warfarin, or antiplatelet agents e.g. aspirin. Patients with active bleeding one the first post-operative day will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate postoperative effectiveness and safety of ibuprofen lysinate vaginal solution for a 4 days monitoring period (D1-D4);Secondary Objective: Product safety assessment based on adverse events recording;Primary end point(s): Efficacy assessment of ibuprofen lysinate vaginal solution regarding a) pain reduction based on visual VAS pain scale and b) improvement of inflammation markers based on vaginal swabs cultivation preoperatively and at the end of treatment period (Day 4);Timepoint(s) of evaluation of this end point: End of treatment period (Day 4) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Product safety assessment based on adverse events recording;Timepoint(s) of evaluation of this end point: End of treatment period (Day 4) | — |
Countries
Greece
Contacts
Public ContactRegulatory Affairs department
Ioulia and Irene Tseti Pharmaceutical Laboratories S.A.
Outcome results
None listed