Breast Exicision BiopsyPhase 4PANDANCT07154446
Study Comparing Dynastat and Parestat Pain Relief Medications for Patients After Breast Surgery
A Phase 4 study testing Parestat(generic parecoxib) and Dynastat (original Parecoxib) in people with Breast Exicision Biopsy, run by University of Malaya.
Trial summary
The goal of this clinical trial is to learn if generic parecoxib (Parestat) works as well as the original drug (Dynastat) for treating pain after breast surgery. It will also learn about the safety of both drugs. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Exicision Biopsy
- What is being tested?
- Parestat(generic parecoxib) and Dynastat (original Parecoxib)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years or older. Patients scheduled for elective excision biopsy of the breast. Patients with an American Society of Anesthesiologists (ASA) physical status classification of I or II.
- Patients who can understand and provide written informed consent.
Who cannot join
- Patients with a known allergy or contraindication to parecoxib or any of its excipients.
- Patients with a history of severe gastrointestinal bleeding, ulceration, or perforation.
- Patients with a history of significant cardiovascular disease (e.g., unstable angina, recent myocardial infarction, stroke).
- Patients with uncontrolled hypertension. Patients with severe renal impairment (creatinine clearance < 30 mL/min). Patients with severe hepatic impairment (Child-Pugh Class C). Patients who are pregnant or breastfeeding. Patients taking medications that are contraindicated with parecoxib (refer to drug interaction section).
- Patients with a history of bronchospasm, acute rhinitis, nasal polyps, angioedema, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Dynastat vs. Parestat for Postoperative Analgesia in Breast Surgery: A Non-Inferiority Randomised Controlled Trial
The goal of this clinical trial is to learn if generic parecoxib (Parestat) works as well as the original drug (Dynastat) for treating pain after breast surgery. It will also learn about the safety of both drugs. The main questions it aims to answer are:
- Does Parestat provide pain relief that is not inferior to the pain relief provided by Dynastat?
- What medical problems (adverse events) do participants have when taking Parestat compared to Dynastat? Researchers will compare Parestat to Dynastat to see if the generic version also works to treat postoperative pain.
Read more
Participants will:
- Be randomly assigned to receive either Dynastat or Parestat during their surgery.
- Have their pain level assessed using the Visual Analog Scale (VAS) upon arrival in the recovery bay, 6 and 24 hours after surgery.
- Be monitored for common side effects like nausea, vomiting, and changes in blood pressure for 24 hours.
Read the detailed description
The goal of this clinical trial is to determine whether generic parecoxib (Parestat) is as effective as the original parecoxib (Dynastat) for treating pain following breast surgery. The trial will also assess the safety of both medications. The main questions it aims to answer are:
- Does generic parecoxib (Parestat) provide the same level of pain relief as original parecoxib (Dynastat) after breast biopsy surgery?
- What side effects do participants experience when taking either medication?
Researchers will compare Parestat to Dynastat to see if the generic version is equally effective for managing postoperative pain.
Participants in the study will:
- Receive either Parestat or Dynastat during their breast excision biopsy surgery.
- Have their pain levels measured using a pain scale at three time points: in the recovery room, before transferring to the ward, and 24 hours after surgery.
- Be monitored for side effects such as nausea, changes in blood pressure, swelling, and other adverse reactions for 24 hours.
- Be kept unaware of which medication they received (double-blind study design).
The study will involve 60 adult women undergoing elective breast biopsy surgery, with 30 participants in each treatment group.t group.
- Conditions
- Breast Exicision Biopsy
- Being tested
- Parestat(generic parecoxib), Dynastat (original Parecoxib)
- Keywords
- Randomised control trial, parecoxib, Breast excision biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parestat(generic parecoxib)Drug
This arm will receive IV Parestat 40mg during surgery
Dynastat (original Parecoxib)Drug
This arm will receive IV Dynastat 40mg during surgery
| Study group | Role | What they receive |
|---|---|---|
| Parestat Group, Parestat(generic parecoxib) | Experimental | Patients receiving IV Parestat 40mg (generic Parecoxib) will have it administered by an anaesthesiologist after the induction of general anaesthesia and before the surgeon makes the skin incision. Receives: Drug: Parestat(generic parecoxib) |
| Dynastat group, Dynastat(Original Parecoxib) | Active comparator | Patients receiving IV Dynastat 40mg (original Parecoxib) will have it administered by an anaesthesiologist after the induction of general anaesthesia and before the surgeon makes the skin incision. Receives: Drug: Dynastat (original Parecoxib) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score
Each participant's pain score will be assessed using the Numeric Rating Scale (NRS) at three time points: upon arrival in the recovery bay, before discharge from the recovery bay, and 24 hours postoperatively.
The NRS ranges 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Highest score reflect worst outcome
Measured: 24 hours after surgery completed
Secondary outcomes (1)
Adverse events
To detect and compare the incidence of common adverse events between the two groups, specifically:
- Nausea and vomiting, constipation
- Changes in blood pressure, differences 20% from baseline (increase or decrease)
- Edema
- Pruritus
- Gastritis
- Bronchospasm
Measured: 24 hours after completion of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Exicision BiopsyStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Fariz Bin Elias, University of Malaya
- Investigators
- Ahmad Fariz Elias, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07154446
- Sponsor's protocol ID
- 202557-15040
- Acronym
- PANDA
- Status last verified
- Aug 2025
- First submitted
- 26 Aug 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices), will be made available beginning 9 months and ending 36 months following article publication to researchers who provide a methodologically sound proposal.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynastat vs. Parestat for Postoperative Analgesia in Breast Surgery: A Non-Inferiority Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07154446
- Acronym / sponsor ID
- PANDA / 202557-15040
- Conditions
- Breast Exicision Biopsy
- Keywords
- Randomised control trial, parecoxib, Breast excision biopsy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 4 Sep 2025 (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.
The goal of this clinical trial is to learn if generic parecoxib (Parestat) works as well as the original drug (Dynastat) for treating pain after breast surgery. It will also learn about the safety of both drugs. The main questions it aims to answer are:
- Does Parestat provide pain relief that is not inferior to the pain relief provided by Dynastat?
- What medical problems (adverse events) do participants have when taking Parestat compared to Dynastat? Researchers will compare Parestat to Dynastat to see if the generic version also works to treat postoperative pain.
Participants will:
- Be randomly assigned to receive either Dynastat or Parestat during their surgery.
- Have their pain level assessed using the Visual Analog Scale (VAS) upon arrival in the recovery bay, 6 and 24 hours after surgery.
- Be monitored for common side effects like nausea, vomiting, and changes in blood pressure for 24 hours.
Detailed description
The goal of this clinical trial is to determine whether generic parecoxib (Parestat) is as effective as the original parecoxib (Dynastat) for treating pain following breast surgery. The trial will also assess the safety of both medications. The main questions it aims to answer are:
- Does generic parecoxib (Parestat) provide the same level of pain relief as original parecoxib (Dynastat) after breast biopsy surgery?
- What side effects do participants experience when taking either medication?
Researchers will compare Parestat to Dynastat to see if the generic version is equally effective for managing postoperative pain.
Participants in the study will:
- Receive either Parestat or Dynastat during their breast excision biopsy surgery.
- Have their pain levels measured using a pain scale at three time points: in the recovery room, before transferring to the ward, and 24 hours after surgery.
- Be monitored for side effects such as nausea, changes in blood pressure, swelling, and other adverse reactions for 24 hours.
- Be kept unaware of which medication they received (double-blind study design).
The study will involve 60 adult women undergoing elective breast biopsy surgery, with 30 participants in each treatment group.t group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parestat Group, Parestat(generic parecoxib) | Experimental | Drug: Parestat(generic parecoxib)Patients receiving IV Parestat 40mg (generic Parecoxib) will have it administered by an anaesthesiologist after the induction of general anaesthesia and before the surgeon makes the skin incision. |
| Dynastat group, Dynastat(Original Parecoxib) | Active comparator | Drug: Dynastat (original Parecoxib)Patients receiving IV Dynastat 40mg (original Parecoxib) will have it administered by an anaesthesiologist after the induction of general anaesthesia and before the surgeon makes the skin incision. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 18 years or older. Patients scheduled for elective excision biopsy of the breast. Patients with an American Society of Anesthesiologists (ASA) physical status classification of I or II.
- Patients who can understand and provide written informed consent.
Key exclusion criteria (5 listed)
- Patients with a known allergy or contraindication to parecoxib or any of its excipients.
- Patients with a history of severe gastrointestinal bleeding, ulceration, or perforation.
- Patients with a history of significant cardiovascular disease (e.g., unstable angina, recent myocardial infarction, stroke).
- Patients with uncontrolled hypertension. Patients with severe renal impairment (creatinine clearance < 30 mL/min). Patients with severe hepatic impairment (Child-Pugh Class C). Patients who are pregnant or breastfeeding. Patients taking medications that are contraindicated with parecoxib (refer to drug interaction section).
- Patients with a history of bronchospasm, acute rhinitis, nasal polyps, angioedema, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
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 |
|---|---|---|
| Parestat(generic parecoxib)This arm will receive IV Parestat 40mg during surgery | Drug | Parestat Group, Parestat(generic parecoxib) |
| Dynastat (original Parecoxib)This arm will receive IV Dynastat 40mg during surgery | Drug | Dynastat group, Dynastat(Original Parecoxib) |
Primary outcome
Pain Score
Time frame: 24 hours after surgery completed
Each participant's pain score will be assessed using the Numeric Rating Scale (NRS) at three time points: upon arrival in the recovery bay, before discharge from the recovery bay, and 24 hours postoperatively. The NRS ranges 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Highest score reflect worst outcome
1 secondary outcome
Adverse events
Time frame: 24 hours after completion of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices), will be made available beginning 9 months and ending 36 months following article publication to researchers who provide a methodologically sound proposal.
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.
Ahmad Fariz Elias principal investigator
University of Malaya
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Parestat(generic parecoxib) and Dynastat (original Parecoxib) in people with Breast Exicision Biopsy, run by University of Malaya.
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 2 inclusion and 5 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: opening soon, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmad Fariz Elias (+60194062520, fariz.elias@ummc.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score (time frame: 24 hours after surgery completed). 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 22 Sep 2025.