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Fixed Combination of Dipirone and Codeine Compared to the Isolated Use of Dipyrone and Codeine in Controlling Pain After Pelvic-abdominal Surgery. (DIPICOR)

Primary Purpose

Pain, Postoperative

Status
Recruiting
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Fixed dose combination Dipyrone and Codeine
Dipyrone
Codeine
Sponsored by
Brazilian Clinical Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Dipirone, Codeine, pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ≥ 18 years;
  • Patients in the 1st postoperative period of open abdominal or pelvic surgery (last 24 hours) and receiving short duration analgesics or opioids in any route of administration on the previous day, being able to receive oral medication and scheduled home discharge in hours or days, with pain moderate to intense intensity (defined as VAS pain ≥ 4);
  • Have signed the informed consent form.

Exclusion Criteria:

  • Surgical complications to the inclusion of the participant in the research;
  • Other serious comorbidities at the discretion of the investigators (such as a history of renal, hepatic, cardiac or other peptic ulcer);
  • History of chronic and current use of opioids or other analgesics;
  • Users of alcohol or illicit drugs;
  • Use of drugs with the potential to interact with study drugs;
  • Allergy, hypersensitivity or known contraindication to the use of components of the study drug;
  • Psychiatric or social disorders that prevent adequate follow-up to the protocol;
  • Show inability to understand and perform current pain assessments in the study;
  • Women of childbearing potential, defined as all physiologically capable women of childbearing, unless they are using effective contraceptive methods while administering study medication;
  • Any clinical condition that the investigator considers to generate risk to the patient or interfere with the conduct of the study;
  • Participation in another clinical study in less than a year (unless participation by the principal investigator is justified).

Sites / Locations

  • Associação Hospital de Caridade Ijuí - Núcleo de Ensino e PesquisaRecruiting
  • Hospital Universitário São Francisco na Providência de DeusRecruiting
  • Santa Casa de Misericórdia de VotuporangaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group

Control group

Arm Description

Outcomes

Primary Outcome Measures

Average of sum of the pain difference
The primary endpoint of the study is the average sum of the pain difference after study medication compared to the baseline by visual analogic scale from 0 to 10 cm, where 0 = no pain, and 10 = the worst imaginable pain)

Secondary Outcome Measures

Average of visual analogic scale score
The average visual analogic scale score (visual analogic scale from 0 to 10 cm, where 0 = no pain and 10 = the worst imaginable pain) measured at rest and during handling in subsequent medication.
VRS (verbal scale and relief assessment pain)
VRS (verbal scale and relief assessment pain) where 0 = no pain relief, 1 = mild pain relief, 2 = moderate pain relief, 3 = good pain relief and 4 = excellent pain relief)
Assessment of complete pain relief by verbal scale and relief assessment pain (VRS)
Assessment of complete pain relief by verbal scale assessment of pain relief (VRS where 0 = no pain relief, 1 = mild pain relief, 2 = moderate pain relief, 3 = good pain relief, and 4 = excellent pain relief).
Need for medication of rescue
Number of patients who need medication of rescue (Patients who did not experience adequate pain relief with study medication who use additional analgesics, ie, rescue medication).
Assessment of satisfaction with treatment by the participant
Assessment of satisfaction with treatment by the participant using a standard categorical rating scale: Patient-reported global evaluation of Eficacy (PGE) scale of 5-points where 0=poor, 1=fair, 2=good , 3=very good, and 5=excellent response to therapy).
Presence of adverse events

Full Information

First Posted
October 7, 2020
Last Updated
May 2, 2023
Sponsor
Brazilian Clinical Research Institute
Collaborators
Brainfarma Industria Química e Farmacêutica S/A
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1. Study Identification

Unique Protocol Identification Number
NCT04641338
Brief Title
Fixed Combination of Dipirone and Codeine Compared to the Isolated Use of Dipyrone and Codeine in Controlling Pain After Pelvic-abdominal Surgery.
Acronym
DIPICOR
Official Title
Randomized, Open, Multicentre, National Superiority Clinical Trial to Assess the Combination of Fixed Dosage of Dipyrone and Codeine Compared to the Isolated Use of Components in the Control of Moderate to Severe Pain After Open Pelvic-abdominal Surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 16, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Brazilian Clinical Research Institute
Collaborators
Brainfarma Industria Química e Farmacêutica S/A

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Phase III clinical trial, multicentre of superiority, randomized, open, parallel groups, with active control and use of postoperative oral medication (multiple doses of medication).
Detailed Description
The main objective is to evaluate the effectiveness and safety of the association in relation to the isolated use of medicines.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Dipirone, Codeine, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
328 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Fixed dose combination Dipyrone and Codeine
Intervention Description
Fixed dose combination: dipyrone 1000 mg + codeine 30 mg every 6 hours if necessary.
Intervention Type
Drug
Intervention Name(s)
Dipyrone
Intervention Description
use of 1000 mg dipyrone every 6 hours if necessary.
Intervention Type
Drug
Intervention Name(s)
Codeine
Intervention Description
30 mg codeine every 6 hours if necessary.
Primary Outcome Measure Information:
Title
Average of sum of the pain difference
Description
The primary endpoint of the study is the average sum of the pain difference after study medication compared to the baseline by visual analogic scale from 0 to 10 cm, where 0 = no pain, and 10 = the worst imaginable pain)
Time Frame
During hospitalization (around 48 hours post surgical procedure)
Secondary Outcome Measure Information:
Title
Average of visual analogic scale score
Description
The average visual analogic scale score (visual analogic scale from 0 to 10 cm, where 0 = no pain and 10 = the worst imaginable pain) measured at rest and during handling in subsequent medication.
Time Frame
During hospitalization (around 48 hours post surgical procedure)
Title
VRS (verbal scale and relief assessment pain)
Description
VRS (verbal scale and relief assessment pain) where 0 = no pain relief, 1 = mild pain relief, 2 = moderate pain relief, 3 = good pain relief and 4 = excellent pain relief)
Time Frame
During hospitalization (around 48 hours post surgical procedure)
Title
Assessment of complete pain relief by verbal scale and relief assessment pain (VRS)
Description
Assessment of complete pain relief by verbal scale assessment of pain relief (VRS where 0 = no pain relief, 1 = mild pain relief, 2 = moderate pain relief, 3 = good pain relief, and 4 = excellent pain relief).
Time Frame
During hospitalization (around 48 hours post surgical procedure)
Title
Need for medication of rescue
Description
Number of patients who need medication of rescue (Patients who did not experience adequate pain relief with study medication who use additional analgesics, ie, rescue medication).
Time Frame
During hospitalization (around 48 hours post surgical procedure)
Title
Assessment of satisfaction with treatment by the participant
Description
Assessment of satisfaction with treatment by the participant using a standard categorical rating scale: Patient-reported global evaluation of Eficacy (PGE) scale of 5-points where 0=poor, 1=fair, 2=good , 3=very good, and 5=excellent response to therapy).
Time Frame
14 days
Title
Presence of adverse events
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥ 18 years; Patients in the 1st postoperative period of open abdominal or pelvic surgery (last 24 hours) and receiving short duration analgesics or opioids in any route of administration on the previous day, being able to receive oral medication and scheduled home discharge in hours or days, with pain moderate to intense intensity (defined as VAS pain ≥ 4); Have signed the informed consent form. Exclusion Criteria: Surgical complications to the inclusion of the participant in the research; Other serious comorbidities at the discretion of the investigators (such as a history of renal, hepatic, cardiac or other peptic ulcer); History of chronic and current use of opioids or other analgesics; Users of alcohol or illicit drugs; Use of drugs with the potential to interact with study drugs; Allergy, hypersensitivity or known contraindication to the use of components of the study drug; Psychiatric or social disorders that prevent adequate follow-up to the protocol; Show inability to understand and perform current pain assessments in the study; Women of childbearing potential, defined as all physiologically capable women of childbearing, unless they are using effective contraceptive methods while administering study medication; Any clinical condition that the investigator considers to generate risk to the patient or interfere with the conduct of the study; Participation in another clinical study in less than a year (unless participation by the principal investigator is justified).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brainfarma Indústria Química Farmacêutica
Phone
5511 45072111
Email
juliana.augusto@brainfarma.ind.br
Facility Information:
Facility Name
Associação Hospital de Caridade Ijuí - Núcleo de Ensino e Pesquisa
City
Ijuí
State/Province
Rio Grande Do Sul
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernando Vargas Bueno, MD
Facility Name
Hospital Universitário São Francisco na Providência de Deus
City
Bragança Paulista
State/Province
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ciro Carneiro Medeiros, MD
Facility Name
Santa Casa de Misericórdia de Votuporanga
City
Votuporanga
State/Province
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juliana Meziara, MD

12. IPD Sharing Statement

Learn more about this trial

Fixed Combination of Dipirone and Codeine Compared to the Isolated Use of Dipyrone and Codeine in Controlling Pain After Pelvic-abdominal Surgery.

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