NCT05607641 - Efficacy and Safety Study of Ketorolac / Pitofenone / Fenpiverinium for the Treatment of Patients With Pain After Surgical Abdominal and Pelvic Operations | Biotech Hunter

Enrollment

424

Participants

Timeline

Start Date

July 7, 2021

Primary Completion Date

May 7, 2022

Study Completion Date

May 13, 2022

Conditions

Postsurgical Pain

Interventions

DRUG

Ketorolac tromethamine, solution for injection then Neospastil, film-coated tablets

"These medicines were used for patients of Group 1 (phase II) and Group 4 (phase III).~Stage 1 (1st day of study treatment) - Ketorolac tromethamine, solution for injection, 1 ml every 8 hours.~Stage 2 (2nd day of study treatment) - Neospastil, film-coated tablets, 1 tablet every 6 hours.~Stage 3 (3rd-5th days of study treatment) - Neospastil, film-coated tablets, 1 tablet on demand with an interval of at least 6 hours, not more than 4 tablets per day."

DRUG

Ketorolac tromethamine, solution for injection then Ketorolac tromethamine, coated tablets

"These medicines were used for patients of Group 2 (phase II) and Group 5 (phase III).~Stage 1 (1st day of study treatment) - Ketorolac tromethamine, solution for injection, 1 ml every 8 hours.~Stage 2 (2nd day of study treatment) - Ketorolac tromethamine, coated tablets, 1 tablet every 6 hours.~Stage 3 (3rd-5th days of study treatment) - Ketorolac tromethamine, coated tablets, 1 tablet on demand with an interval of at least 6 hours, not more than 4 tablets per day."

DRUG

Neospastil, solution for injection then Neospastil, film-coated tablets

"These medicines were used for patients of Group 3 (phase II) and Group 6 (phase III).~Stage 1 (1st day of study treatment) - Neospastil, solution for injection, 2 ml every 8 hours.~Stage 2 (2nd day of study treatment) - Neospastil, film-coated tablets, 1 tablet every 6 hours.~Stage 3 (3rd-5th days of study treatment) - Neospastil, film-coated tablets, on demand 1 tablet with an interval of at least 6 hours, not more than 4 tablets per day."

Trial Locations (14)

Unknown

"Regional municipal nonprofitable institution Chernivtsi regional clinical hospital, urological department", Chernivtsi

"Communal enterprise Dnipropetrovsk Regional Clinical Hospital named after І.І. Mechnikov Dnipropetrovsk Regional Council, urology department №1", Dnipro

"Communal enterprise Dnipropetrovsk Regional Clinical Hospital named after І.І. Mechnikov Dnipropetrovsk Regional Council, urology department №2", Dnipro

"Communal noncomercial enterprise of the Kharkiv Regional Council Regional Medical Clinical Center of Urology and Nephrology named after V.I. Shapovala, urology department №5", Kharkiv

"Communal noncomercial enterprise Kyiv City Clinical Hospital #3 Kyiv City Council (Kyiv City State Administration), urological department", Kyiv

"Medical Center of the LLC Harmony of Beauty", Kyiv

"State Institution Institute of Urology of the National Academy of Medical Sciences of Ukraine, I Urological Department", Kyiv

"Communal noncomercial enterprise of the Lviv Regional Council Lviv Regional Clinical Hospital, department of urology", Lviv

"Municipal Non-profit Enterprise Lviv Clinical Hospital for Emergency Medical Care", Lviv

"Communal noncomercial enterprise City Clinical Hospital #10 Odesa City Council, urological department #2", Odesa

"Medical-diagnostic center Zakarpattya center of surgical innovations Astra-med of limited liability company Clinic of healthy family Astramed", Uzhhorod

"Communal noncomercial enterprise Vinnytsia City Clinical Hospital Mother and Child Center, department of gynecology with minimally invasive operations", Vinnytsia

"Limited Liability Company Innomed Center of Endosurgery", Vinnytsia

"Communal noncomercial enterprise City Hospital of Emergency and Ambulance of Zaporizhia City Council, Department of Surgery with the Center for Gastrointestinal Bleeding", Zaporizhzhya