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

NCT05607641 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 424

Last updated 2022-11-07

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Darnitsa Pharmaceutical Company

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-07
Primary Completion
2022-05-07
Completion
2022-05-13

Countries

  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05607641 on ClinicalTrials.gov