A Clinical Trial of GRT7040 in Adults With Acute Pain Following Bunionectomy
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGrünenthal GmbH
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
GRT7040
DrugThe trial will compare three different doses of GRT7040 (Low, Medium \[Mid\] and High doses)
Hydrocodone bitartrate/ acetaminophen (HB/APAP)
DrugReference drug
Placebo (matched to HB/APAP)
DrugDummy treatment
Placebo (matched to GRT7040)
DrugDummy treatment
Treatment groups
400 Participants
are divided into 5 treatment groupsGroup A: GRT7040: Low DoseExperimental treatment 1 intervention
Group B: GRT7040: Mid DoseExperimental treatment 1 intervention
Group C: GRT7040: High DoseExperimental treatment 1 intervention
Group D: HB/APAPActive comparator 1 intervention
Group E: PlaceboPlacebo comparator 2 interventions
Trial outcomes
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.
Time frame
Baseline to 48 hours after first dose of IMPSecondary outcomes
1
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)2
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 IMP3
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 IMP4
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 IMPLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: