Efficacy and Safety Study of Ketorolac / Pitofenone / Fenpiverinium for the Treatment of Patients With Pain After Surgical Abdominal and Pelvic Operations
Condition: Postsurgical Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    


Intervention name(s): Ketorolac tromethamine, solution for injection then Neospastil, film-coated tablets; Ketorolac tromethamine, solution for injection then Ketorolac tromethamine, coated tablets; Neospastil, solution for injection then Neospastil, film-coated tablets
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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.; 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.; 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.
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A prospective, multicenter, randomized, open-label, parallel-group comparative clinical trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: postsurgical pain; abdominal operation; pelvic operation; ketorolac tromethamine; pitofenone hydrochloride; fenpiverinium bromide