Acute PainPhase 2NCT07807644
A Clinical Trial of GRT7040 in Adults With Acute Pain Following Bunionectomy
A Phase 2 study testing GRT7040 and Hydrocodone bitartrate/ acetaminophen (HB/APAP) in people with Acute Pain and Bunionectomy, run by Grünenthal GmbH.
Trial summary
This is a Phase 2 clinical trial of GRT7040, currently being developed for the treatment of moderate-to-severe acute pain. The primary purpose of this trial is to assess efficacy and safety of GRT7040 compared with placebo in adult participants with acute pain following bunionectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Pain, Bunionectomy
- What is being tested?
- GRT7040 and Hydrocodone bitartrate/ acetaminophen (HB/APAP)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Sep 2027
- Phase
- Phase 2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults scheduled for a primary unilateral bunionectomy with distal first metatarsal osteotomy and internal fixation under regional anesthesia.
- Able and willing to provide informed consent and comply with study procedures.
- Body weight ≥50 kg and BMI 18 to 40 kg/m².
- Medically fit for surgery and study treatment based on medical history, physical examination, ECG, vital signs, and laboratory assessments.
- Meets protocol-specified contraception requirements.
- After surgery, reports moderate to severe pain (Verbal Rating Scale) with a Numeric Pain Rating Scale (NPRS) score ≥4 within 9 hours after removal of the popliteal sciatic block.
- Able to follow commands and has complied with protocol-required perioperative analgesic guidelines.
Who cannot join
- Clinically significant medical conditions or laboratory abnormalities that could increase risk or interfere with study assessments.
- Major surgery within 6 months prior to screening or anticipated need for major surgery during the study.
- Prior bunionectomy or related surgery on either applicable foot.
- Peripheral neuropathy affecting the legs.
- Clinically significant cardiac disease, arrhythmias, QT prolongation risk, or abnormal ECG findings.
- Sleep apnea requiring positive airway pressure therapy.
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- American Society of Anesthesiologists (ASA) physical status classification ≥3.
- Contraindication, intolerance, allergy, or unwillingness to receive study-related analgesics, NSAIDs, acetaminophen/hydrocodone, local anesthetics, or study drug components.
- Participation in another interventional clinical trial within the protocol-defined exclusion period.
- Significant renal impairment, hepatic impairment, positive HIV, hepatitis B, or hepatitis C tests.
- History of substance abuse or addiction within the previous 3 years or positive drug/alcohol screening as specified by the protocol.
- Blood or plasma donation exceeding protocol limits before screening.
- Pregnant, breastfeeding, planning pregnancy during the study, or unwilling to comply with contraception requirements.
- Postoperative factors precluding randomization, including unsuccessful popliteal block placement, surgical complications, non-adherence to postoperative analgesic requirements, or medical complications during surgery.
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: A Randomized, Double-Blind, Double-Dummy, Placebo- and Active-Controlled, 2-Part Phase 2 Trial to Investigate the Efficacy and Safety of GRT7040 in Adult Participants With Acute Pain Following Bunionectomy
This is a Phase 2 clinical trial of GRT7040, currently being developed for the treatment of moderate-to-severe acute pain. The primary purpose of this trial is to assess efficacy and safety of GRT7040 compared with placebo in adult participants with acute pain following bunionectomy.
The trial will compare three different doses of GRT7040 given from Day 1 until Day 3 (eg, 48 h after the first investigational medicinal product [IMP] administration) of GRT7040 or placebo.
Read the detailed description
This is a randomized, double-blind, double-dummy, placebo- and active controlled, 2-part Phase 2 trial.
In Part A, there will be three trial arms. In Part B there will be five trial arms.
The trial duration for Parts A and B will be approximately 6 weeks (notwithstanding visit windows) consisting of a Screening Period (up to 28 Days), randomization and IMP administration on Day 1, followed by a 48 h of Treatment Period, and a 10-day Safety Follow-up (SFU) Period.
Excluding the Screening Period, each participant will participate in the trial for approximately 13 (± 2) days (from Day 1 to the End-of-Trial [EoT] Visit).
Screening will occur within 28 days before administration of the IMP. Informed consent will be obtained prior to performing any trial-related procedures or assessments.
- Conditions
- Acute Pain, Bunionectomy
- Being tested
- GRT7040, Hydrocodone bitartrate/ acetaminophen (HB/APAP), Placebo (matched to HB/APAP), Placebo (matched to GRT7040)
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GRT7040Drug
Also called Study drug, IMP
The trial will compare three different doses of GRT7040 (Low, Medium [Mid] and High doses)
Hydrocodone bitartrate/ acetaminophen (HB/APAP)Drug
Also called Active-Control
Reference drug
Placebo (matched to HB/APAP)Drug
Dummy treatment
Placebo (matched to GRT7040)Drug
Dummy treatment
| Study group | Role | What they receive |
|---|---|---|
| GRT7040: Low Dose | Experimental | Similar to all participants within dosing groups in a double-dummy design. Receives: Drug: GRT7040 |
| GRT7040: Mid Dose | Experimental | Similar to all participants within dosing groups in a double-dummy design. Receives: Drug: GRT7040 |
| GRT7040: High Dose | Experimental | Similar to all participants within dosing groups in a double-dummy design. Receives: Drug: GRT7040 |
| HB/APAP | Active comparator | Similar to all participants within dosing groups in a double-dummy design. Receives: Drug: Hydrocodone bitartrate/ acetaminophen (HB/APAP) |
| Placebo | Placebo comparator | Placebo matched to GRT7040 and HB/APAP. Receives: Drug: Placebo (matched to HB/APAP); Drug: Placebo (matched to GRT7040) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-Weighted Sum of Pain Intensity Difference From 0 to 48 Hours (SPID48)
Time-weighted sum of the pain intensity difference as recorded on a Numeric Pain Rating Scale (NPRS) (from 0 = no pain to 10 = pain as bad as you can imagine) from 0 to 48 hours after the first dose of IMP.
Measured: Baseline to 48 hours after first dose of IMP
Secondary outcomes (10)
Incidence of Adverse Events
To assess the safety and tolerability of GRT7040
Measured: From first dose of IMP through End of Treatment visit (Day 13 ± 2 days)
Time-Weighted Sum of Pain Intensity Difference From 0 to 24 Hours (SPID24)
Time-weighted sum of the pain intensity difference as recorded on a NPRS (from 0 = no pain to 10 = pain as bad as you can imagine) from 0 to 24 hours after the first dose of IMP.
Measured: Baseline to 24 hours after first dose of IMP
Time-Weighted Sum of Pain Intensity Difference From 4 to 48 Hours (SPID4-48)
Time-weighted sum of the pain intensity difference as recorded on a NPRS (from 0 = no pain to 10 = pain as bad as you can imagine) from 4 to 48 hours after the first dose of IMP.
Measured: 4 to 48 hours after first dose of IMP
Participants With ≥30%, ≥50%, and ≥70% Reduction in Pain From Baseline
Percentage of participants with ≥30%, ≥50%, and ≥70% reduction in pain from Baseline as measured by a NPRS (from 0 = no pain to 10 = pain as bad as you can imagine) at 12, 24, and 48 hours.
Measured: At 12, 24, and 48 hours after first dose of IMP
Time to ≥2 point Reduction in Pain From Baseline
Time to a ≥2 point reduction in pain from Baseline as measured by a NPRS (from 0 = no pain to 10 = pain as bad as you can imagine) after the first dose of IMP.
Measured: From first dose of IMP through 48 hours after first dose
Time to First Rescue Medication Use
Time to first rescue medication use after the first dose of IMP.
Measured: From first dose of IMP through 48 hours after first dose
Percentage of participants using rescue medication
Percentage of participants using rescue medication 0 to 48 h after the first dose of IMP.
Measured: From first dose of IMP through 48 hours after first dose
Total rescue medication use
Total rescue medication use 0 to 48 h after the first dose GRT7040 versus placebo
Measured: From first dose of IMP through 48 hours after first dose
Participants Reporting "Good" or "Excellent" on the Patient Global Assessment
Proportion of participants reporting "Good" or "Excellent" on the Patient Global Assessment at 24 and 48 hours after the first dose of IMP.
Measured: At 24 and 48 hours after first dose of IMP
Time to Perceptible Pain Relief and Meaningful Pain Relief
Time to onset of perceptible pain relief and meaningful pain relief assessed using the double-stopwatch method after the first dose of IMP
Measured: From first dose of IMP through 24 hours after first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grünenthal GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07807644
- Sponsor's protocol ID
- KF7040-21
- Other IDs
- U1111-1342-0262
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Double-Dummy, Placebo- and Active-Controlled, 2-Part Phase 2 Trial to Investigate the Efficacy and Safety of GRT7040 in Adult Participants With Acute Pain Following Bunionectomy
- ClinicalTrials.gov ID
- NCT07807644
- Acronym / sponsor ID
- KF7040-21
- Conditions
- Acute Pain, Bunionectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Grünenthal GmbHIndustry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 8 Sep 2026 (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.
This is a Phase 2 clinical trial of GRT7040, currently being developed for the treatment of moderate-to-severe acute pain. The primary purpose of this trial is to assess efficacy and safety of GRT7040 compared with placebo in adult participants with acute pain following bunionectomy.
The trial will compare three different doses of GRT7040 given from Day 1 until Day 3 (eg, 48 h after the first investigational medicinal product [IMP] administration) of GRT7040 or placebo.
Detailed description
This is a randomized, double-blind, double-dummy, placebo- and active controlled, 2-part Phase 2 trial.
In Part A, there will be three trial arms. In Part B there will be five trial arms.
The trial duration for Parts A and B will be approximately 6 weeks (notwithstanding visit windows) consisting of a Screening Period (up to 28 Days), randomization and IMP administration on Day 1, followed by a 48 h of Treatment Period, and a 10-day Safety Follow-up (SFU) Period.
Excluding the Screening Period, each participant will participate in the trial for approximately 13 (± 2) days (from Day 1 to the End-of-Trial [EoT] Visit).
Screening will occur within 28 days before administration of the IMP. Informed consent will be obtained prior to performing any trial-related procedures or assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| GRT7040: Low Dose | Experimental | Drug: GRT7040Similar to all participants within dosing groups in a double-dummy design. |
| GRT7040: Mid Dose | Experimental | Drug: GRT7040Similar to all participants within dosing groups in a double-dummy design. |
| GRT7040: High Dose | Experimental | Drug: GRT7040Similar to all participants within dosing groups in a double-dummy design. |
| HB/APAP | Active comparator | Drug: Hydrocodone bitartrate/ acetaminophen (HB/APAP)Similar to all participants within dosing groups in a double-dummy design. |
| Placebo | Placebo comparator | Drug: Placebo (matched to HB/APAP), Drug: Placebo (matched to GRT7040)Placebo matched to GRT7040 and HB/APAP. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults scheduled for a primary unilateral bunionectomy with distal first metatarsal osteotomy and internal fixation under regional anesthesia.
- Able and willing to provide informed consent and comply with study procedures.
- Body weight ≥50 kg and BMI 18 to 40 kg/m².
- Medically fit for surgery and study treatment based on medical history, physical examination, ECG, vital signs, and laboratory assessments.
- Meets protocol-specified contraception requirements.
Key exclusion criteria (14 listed)
- Clinically significant medical conditions or laboratory abnormalities that could increase risk or interfere with study assessments.
- Major surgery within 6 months prior to screening or anticipated need for major surgery during the study.
- Prior bunionectomy or related surgery on either applicable foot.
- Peripheral neuropathy affecting the legs.
- Clinically significant cardiac disease, arrhythmias, QT prolongation risk, or abnormal ECG findings.
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 |
|---|---|---|
| GRT7040Also: Study drug, IMPThe trial will compare three different doses of GRT7040 (Low, Medium [Mid] and High doses) | Drug | GRT7040: High Dose, GRT7040: Low Dose, GRT7040: Mid Dose |
| Hydrocodone bitartrate/ acetaminophen (HB/APAP)Also: Active-ControlReference drug | Drug | HB/APAP |
| Placebo (matched to HB/APAP)Dummy treatment | Drug | Placebo |
| Placebo (matched to GRT7040)Dummy treatment | Drug | Placebo |
Primary outcome
Time-Weighted Sum of Pain Intensity Difference From 0 to 48 Hours (SPID48)
Time frame: Baseline to 48 hours after first dose of IMP
Time-weighted sum of the pain intensity difference as recorded on a Numeric Pain Rating Scale (NPRS) (from 0 = no pain to 10 = pain as bad as you can imagine) from 0 to 48 hours after the first dose of IMP.
10 secondary outcomes
Incidence of Adverse Events
Time frame: From first dose of IMP through End of Treatment visit (Day 13 ± 2 days)
Time-Weighted Sum of Pain Intensity Difference From 0 to 24 Hours (SPID24)
Time frame: Baseline to 24 hours after first dose of IMP
Time-Weighted Sum of Pain Intensity Difference From 4 to 48 Hours (SPID4-48)
Time frame: 4 to 48 hours after first dose of IMP
Participants With ≥30%, ≥50%, and ≥70% Reduction in Pain From Baseline
Time frame: At 12, 24, and 48 hours after first dose of IMP
Time to ≥2 point Reduction in Pain From Baseline
Time frame: From first dose of IMP through 48 hours after first dose
Time to First Rescue Medication Use
Time frame: From first dose of IMP through 48 hours after first dose
Percentage of participants using rescue medication
Time frame: From first dose of IMP through 48 hours after first dose
Total rescue medication use
Time frame: From first dose of IMP through 48 hours after first dose
Participants Reporting "Good" or "Excellent" on the Patient Global Assessment
Time frame: At 24 and 48 hours after first dose of IMP
Time to Perceptible Pain Relief and Meaningful Pain Relief
Time frame: From first dose of IMP through 24 hours after first dose
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 15 Sep 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GRT7040 and Hydrocodone bitartrate/ acetaminophen (HB/APAP) in people with Acute Pain and Bunionectomy, run by Grünenthal GmbH.
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 7 inclusion and 14 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 15 Sep 2026. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Grünenthal Clinical Trial Helpdesk (+49 241 569 3223, clinical-trials@grunenthal.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-Weighted Sum of Pain Intensity Difference From 0 to 48 Hours (SPID48) (time frame: Baseline to 48 hours after first dose of IMP). 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 15 Sep 2026.