Pain, PostoperativePhase 3DIPICORNCT04641338
Fixed Combination of Dipyrone and Codeine for Controlling Pain After Pelvic-abdominal Surgery
A Phase 3 study testing Fixed dose combination Dipyrone and Codeine, Dipyrone and Codeine in people with Pain, Postoperative, run by Brazilian Clinical Research Institute at 3 sites in Brazil.
Trial summary
Phase III clinical trial, multicentre, superiority, randomized, open, parallel groups, with active control and use of postoperative oral medication (multiple doses of medication). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Fixed dose combination Dipyrone and Codeine, Dipyrone and Codeine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 491 participants
- Where
- 3 sitesBrazil
- Study dates
- 16 Mar 2023to 17 May 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women aged 18 years or older;
- Be able to sign the ICF approved by the IEC and to perform and understand all the study procedures and instructions;
- Show post-anesthesia recovery with a score greater than or equal to 8 on the modified Aldrete and Kroulik Scale;
- Experience pain intensity according to the visual analogue scale (VAS) of 3.0 to 10 cm (moderate to severe pain) immediately after surgery;
- Have an elective open abdominal-pelvic surgery scheduled, not due to malignant neoplasm, to be performed within 4 weeks of screening;
- Estimated hospital stay for at least 48 hours after the procedure.
Who cannot join
- Surgical complications during participant enrollment in the research;
- Surgery with indication for treatment of confirmed or suspected malignant neoplasm;
- Chronic use of any non-steroidal anti-inflammatory drugs;
- Suspected paralytic ileus or intestinal obstruction;
- Inability to use oral drugs postoperatively;
- Videolaparoscopic surgery;
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- History of chronic and current use of opioids or other analgesics;
- Use of concomitant modalities of intravenous or neuraxial analgesia (spinal and epidural) with placement of an epidural catheter for use in the postoperative period, or regional blockade, where the expected duration of analgesia administered intravenously or neuroaxially is maintained after 24 hours of the surgical procedure or randomization, whichever occurs first;
- Use of immunosuppressive therapy in the last 24 hours prior to surgery;
- Participants with uncontrollable vomiting present in the postoperative period;
- Abusive user of alcohol or illicit drugs;
- Use of drugs with potential interaction with the study drugs;
- Allergy, hypersensitivity, or known contraindication to the use of ingredients of the study drug;
- Psychiatric or social disorders that prevent the appropriate compliance with the protocol;
- Demonstrate inability to understand and perform current pain assessments in the study;
- Women who are pregnant, breastfeeding, planning to become pregnant, or who have a positive urine pregnancy test.
- Participants who test positive for COVID-19 (upon presentation of the test report at the time of screening or prior to randomization);
- Participation in another clinical trial within less than one year (unless the participation is warranted by the principal investigator);
- Presence of decompensated diabetes mellitus;
- History of decompensated obstructive or restrictive respiratory disease;
- Current symptoms or past history of gastrointestinal bleeding;
- History of blood dyscrasia or chronic disease of any nature that contraindicates the participant's participation at the investigator's discretion;
- Inability to understand and perform the pain assessments during the study;
- Hypersensitivity or contraindication to the use of ingredients of the study drugs;
- Grade III obesity (BMI above 40);
- Presence of one or more flu-like symptoms, such as: fever, cough, dyspnea, myalgia and fatigue, respiratory symptoms, gastrointestinal symptoms (such as diarrhea) within 14 days prior to the screening or randomization visit;
- Other serious comorbidities at the investigators' discretion (such as history of renal, hepatic, cardiac or other peptic ulcer);
- Any clinical condition that the investigator considers to pose a risk to the patient or interfere with study conduction.
Trial locations and contacts
3 sites in 1 country.
Brazil3 sites
Hospital Universitário São Francisco na Providência de Deus
Bragança Paulista, São Paulo
Associação Hospital de Caridade Ijuí - Núcleo de Ensino e Pesquisa
Ijuí, Rio Grande do Sul
Santa Casa de Misericórdia de Votuporanga
Votuporanga, São Paulo
About this study
Official title: Randomized, Multicentre, Superiority Clinical Trial to Assess the Combination of Fixed Dosage Dipyrone and Codeine Compared to the Isolated Use of Components in the Control of Pain After Open Pelvic-abdominal Surgery
Phase III clinical trial, multicentre, superiority, randomized, open, parallel groups, with active control and use of postoperative oral medication (multiple doses of medication).
Read the detailed description
The main objective is to evaluate the effectiveness and safety of the association in relation to the isolated use of medicines.
- Conditions
- Pain, Postoperative
- Being tested
- Fixed dose combination Dipyrone and Codeine, Dipyrone, Codeine
- Keywords
- Codeine, pain, Dipyrone
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixed dose combination Dipyrone and CodeineDrug
Fixed dose combination: dipyrone 1000 mg + codeine 30 mg every 6 hours
DipyroneDrug
use of 1000 mg dipyrone every 6 hours
CodeineDrug
30 mg codeine every 6 hours.
| Study group | Role | What they receive |
|---|---|---|
| Combination therapy group | Experimental | Not described Receives: Drug: Fixed dose combination Dipyrone and Codeine |
| Dipyrone | Active comparator | Not described Receives: Drug: Dipyrone |
| Codeine | Active comparator | Not described Receives: Drug: Codeine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants achieving at least 50% of maximum pain relief within 6 hours
Proportion of participants achieving at least 50% of maximum pain relief within 6 hours after first drug administration, through the assessment of total pain relief (TOTPAR) after first drug administration. TOTPAR is calculated from the result of the 5-point categorical pain relief scale (adapted PAR scale, with the 5 categories: 1-no relief, 2-mild relief, 3-moderate relief, 4-a lot of relief, and 5-complete relief). The PAR will be evaluated 30 minutes, 1 hour, 1 hour and 30 minutes, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours after drug administration, so that the TOTPAR can take into account the progress of pain relief at 8 different timepoints.
Measured: 6 hours
Secondary outcomes (6)
Pain assessment by the 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.
Measured: 6 hours
Proportion of participants who achieve at least 50% pain reduction
Assessment of the proportion of participants who achieve at least 50% pain reduction within 6 hours, through assessment of SPID (sum of the pain intensity difference) after the first dose of study drugs;
Measured: 6 hours
Assessment of complete pain relief
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).
Measured: 72 hours
Time to pain relief
Median time to pain relief
Measured: During hospitalization
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).
Measured: 14 days
Presence of adverse events
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start16 Mar 2023
- Primary completion15 Mar 2024
- Study completion17 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 491 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brazilian Clinical Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Brainfarma Industria Química e Farmacêutica S/A
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04641338
- Sponsor's protocol ID
- 03/2020
- Acronym
- DIPICOR
- Status last verified
- May 2026
- First submitted
- 7 Oct 2020
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data may be shared with other parties upon reasonable request to the corresponding author of the publications and after agreement with the sponsor.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Multicentre, Superiority Clinical Trial to Assess the Combination of Fixed Dosage Dipyrone and Codeine Compared to the Isolated Use of Components in the Control of Pain After Open Pelvic-abdominal Surgery
- ClinicalTrials.gov ID
- NCT04641338
- Acronym / sponsor ID
- DIPICOR / 03/2020
- Conditions
- Pain, Postoperative
- Keywords
- Codeine, pain, Dipyrone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 491 participants (actual)
- Lead sponsor
- Brazilian Clinical Research InstituteUniversity, hospital or other
- Collaborators
- Brainfarma Industria Química e Farmacêutica S/A
- Study start
- 16 Mar 2023 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 17 May 2024 (actual)
- First posted
- 23 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase III clinical trial, multicentre, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Combination therapy group | Experimental | Drug: Fixed dose combination Dipyrone and Codeine |
| Dipyrone | Active comparator | Drug: Dipyrone |
| Codeine | Active comparator | Drug: Codeine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men or women aged 18 years or older;
- Be able to sign the ICF approved by the IEC and to perform and understand all the study procedures and instructions;
- Show post-anesthesia recovery with a score greater than or equal to 8 on the modified Aldrete and Kroulik Scale;
- Experience pain intensity according to the visual analogue scale (VAS) of 3.0 to 10 cm (moderate to severe pain) immediately after surgery;
- Have an elective open abdominal-pelvic surgery scheduled, not due to malignant neoplasm, to be performed within 4 weeks of screening;
Key exclusion criteria (28 listed)
- Surgical complications during participant enrollment in the research;
- Surgery with indication for treatment of confirmed or suspected malignant neoplasm;
- Chronic use of any non-steroidal anti-inflammatory drugs;
- Suspected paralytic ileus or intestinal obstruction;
- Inability to use oral drugs postoperatively;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fixed dose combination Dipyrone and CodeineFixed dose combination: dipyrone 1000 mg + codeine 30 mg every 6 hours | Drug | Combination therapy group |
| Dipyroneuse of 1000 mg dipyrone every 6 hours | Drug | Dipyrone |
| Codeine30 mg codeine every 6 hours. | Drug | Codeine |
Primary outcome
Proportion of participants achieving at least 50% of maximum pain relief within 6 hours
Time frame: 6 hours
Proportion of participants achieving at least 50% of maximum pain relief within 6 hours after first drug administration, through the assessment of total pain relief (TOTPAR) after first drug administration. TOTPAR is calculated from the result of the 5-point categorical pain relief scale (adapted PAR scale, with the 5 categories: 1-no relief, 2-mild relief, 3-moderate relief, 4-a lot of relief, and 5-complete relief). The PAR will be evaluated 30 minutes, 1 hour, 1 hour and 30 minutes, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours after drug administration, so that the TOTPAR can take into account the progress of pain relief at 8 different timepoints.
6 secondary outcomes
Pain assessment by the visual analogic scale score
Time frame: 6 hours
Proportion of participants who achieve at least 50% pain reduction
Time frame: 6 hours
Assessment of complete pain relief
Time frame: 72 hours
Time to pain relief
Time frame: During hospitalization
Assessment of satisfaction with treatment by the participant
Time frame: 14 days
Presence of adverse events
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: Undecided. The data may be shared with other parties upon reasonable request to the corresponding author of the publications and after agreement with the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fixed dose combination Dipyrone and Codeine, Dipyrone and Codeine in people with Pain, Postoperative, run by Brazilian Clinical Research Institute at 3 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants achieving at least 50% of maximum pain relief within 6 hours (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.