A Clinical Trial of GRT7040 in Adults With Acute Pain Following Bunionectomy

NCT07807644 | Not Yet Recruiting Phase 2 FDA Drug

• 2 other identifiers: KF7040-21U1111-1342-0262
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Acute Pain; Bunionectomy

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 48 hours after first dose of IMP

Secondary Outcomes (10)

• Incidence of Adverse Events

  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)

  Baseline to 24 hours after first dose of IMP

• Time-Weighted Sum of Pain Intensity Difference From 4 to 48 Hours (SPID4-48)

  4 to 48 hours after first dose of IMP

• Participants With ≥30%, ≥50%, and ≥70% Reduction in Pain From Baseline

  At 12, 24, and 48 hours after first dose of IMP

• Time to ≥2 point Reduction in Pain From Baseline

  From first dose of IMP through 48 hours after first dose

Study Arms (5)

GRT7040: Low Dose

EXPERIMENTAL

Similar to all participants within dosing groups in a double-dummy design.

Drug: GRT7040

GRT7040: Mid Dose

EXPERIMENTAL

Similar to all participants within dosing groups in a double-dummy design.

Drug: GRT7040

GRT7040: High Dose

EXPERIMENTAL

Similar to all participants within dosing groups in a double-dummy design.

Drug: GRT7040

HB/APAP

ACTIVE COMPARATOR

Similar to all participants within dosing groups in a double-dummy design.

Drug: Hydrocodone bitartrate/ acetaminophen (HB/APAP)

Placebo

PLACEBO COMPARATOR

Placebo matched to GRT7040 and HB/APAP.

Drug: Placebo (matched to HB/APAP); Drug: Placebo (matched to GRT7040)

Interventions

GRT7040 DRUG

The trial will compare three different doses of GRT7040 (Low, Medium \[Mid\] and High doses)

Also known as: Study drug, IMP

GRT7040: High Dose; GRT7040: Low Dose; GRT7040: Mid Dose

Placebo (matched to HB/APAP) DRUG

Dummy treatment

Placebo

Hydrocodone bitartrate/ acetaminophen (HB/APAP) DRUG

Reference drug

Also known as: Active-Control

HB/APAP

Placebo (matched to GRT7040) DRUG

Dummy treatment

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Grünenthal GmbH: lead

MeSH Terms

Conditions

Acute Pain

Interventions

Drug Evaluation; Inosine Monophosphate; Hydrocodone; Acetaminophen

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Development; Investigative Techniques; Evaluation Studies as Topic; Inosine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Grünenthal Clinical Trial Helpdesk

CONTACT

+49 241 569 3223; clinical-trials@grunenthal.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 8, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 15, 2026

Record last verified: 2026-09