NCT05607641

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

A Multicenter, Randomized, Open-Label, Phase II/III Clinical Trial Evaluating the Efficacy and Safety of a Fixed Combination of Ketorolac / Pitofenone / Fenpiverinium Compared to Active Control in Patients With Pain After Surgical Abdominal and Pelvic Operations

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 424 (actual)
• Sponsor: Darnitsa Pharmaceutical Company · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

Neospastil (ketorolac tromethamine / pitofenone hydrochloride / fenpiverinium bromide fixed-dose combination) in a form of solution for injections and film-coated tablets has been studied as a treatment for pain after surgical abdominal and pelvic operations. The aim of the study was to test the hypothesis that Neospastil was non-inferior (phase II) and superior (phase III) than ketorolac tromethamine monotherapy due to the additional relaxing effect of pitofenone and fenpiverinium on the smooth muscles of internal organs. The study also aimed to show that Neospastil is safe and well-tolerated in people who have pain after surgical abdominal and pelvic operations. Study treatment was initiated with parenteral form of study drug (first 24 hours) and then switched to oral formulation. This trial was conducted in accordance with the ethical principles of Good Clinical Practice and International Council for Harmonization (ICH) Harmonized Tripartite Guidelines.

Conditions

• Postsurgical Pain

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-07-07
• Primary completion: 2022-05-07
• Completion: 2022-05-13
• First posted: 2022-11-07
• Last updated: 2022-11-07

Locations

14 sites across 1 country: Ukraine