A Phase 2 interventional study of GRT7040 and Hydrocodone bitartrate/ acetaminophen (HB/APAP) in Acute Pain and Bunionectomy, sponsored by Grünenthal GmbH. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Grünenthal GmbH · Phase 2, Interventional, and Treatment
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.
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.
1,073 studies on the registry are indexed under Acute Pain; 166 are open to participants now.
This study's planned enrollment of 400 is above the median of 86 across 902 interventional studies indexed under Acute Pain.
Browse Acute Pain studies →Grünenthal GmbH is the lead sponsor of 69 studies on the registry; 3 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 8 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Similar to all participants within dosing groups in a double-dummy design.
Drug: GRT7040
Similar to all participants within dosing groups in a double-dummy design.
Drug: GRT7040
Similar to all participants within dosing groups in a double-dummy design.
Drug: GRT7040
Similar to all participants within dosing groups in a double-dummy design.
Drug: Hydrocodone bitartrate/ acetaminophen (HB/APAP)
Placebo matched to GRT7040 and HB/APAP.
Drug: Placebo (matched to HB/APAP) · Drug: Placebo (matched to GRT7040)
The trial will compare three different doses of GRT7040 (Low, Medium \[Mid\] and High doses)
Also known as: Study drug, IMP
Drug pages: Hydrocodone · Acetaminophen
Reference drug
Also known as: Active-Control
Dummy treatment
Dummy treatment
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.
Time frame: Baseline to 48 hours after first dose of IMP
Incidence of Adverse Events
To assess the safety and tolerability of GRT7040
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-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.
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-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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: From first dose of IMP through 24 hours after first dose
No study locations are listed for this record.
Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.
Of 40 phase 2 interventional studies under Acute Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 23. This study's planned 12 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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