Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New combo pill aims to beat Post-Surgery pain

NCT ID NCT04641338

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This completed Phase 3 trial tested whether a fixed-dose combination of dipyrone and codeine provides better pain relief than either drug alone after open pelvic-abdominal surgery. 491 adults with moderate to severe pain were enrolled. The main goal was to see if more people achieved at least 50% pain relief within 6 hours with the combo pill.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dipyrone and codeine combination
What this could lead to
If successful, this could provide a more effective, single-pill option for managing moderate to severe pain after major surgery.
What could go wrong
This is a completed Phase 3 trial, but results may not apply to all surgeries or pain types. Side effects like nausea, dizziness, or constipation are possible with codeine.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

491 people

The number who actually took part.

Started

Mar 2023

Finished

May 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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; * 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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Pain, postoperative are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Pain Pain, Postoperative

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Associação Hospital de Caridade Ijuí - Núcleo de Ensino e Pesquisa

    Ijuí, Rio Grande do Sul, Brazil

  • Hospital Universitário São Francisco na Providência de Deus

    Bragança Paulista, São Paulo, Brazil

  • Santa Casa de Misericórdia de Votuporanga

    Votuporanga, São Paulo, Brazil

More trials for these conditions

Other studies related to the condition(s) this trial covers.