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The purpose of this study is to evaluate the efficacy and safety of Cebranopadol for acute pain after a Abdominoplasty.
This study is a Phase 3, multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Cebranopadol for the Treatment of Moderate to Severe Acute Pain after Full Abdominoplasty. This study will be conducted in 3 phases: Screening, Treatment, and Follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | Cebranopadol 400 ug (once daily for 2 days) |
|
| Treatment B | Experimental | Cebranopadol 400 ug on Day 1; 200 ug on Day 2 |
|
| Treatment C | Placebo Comparator | Placebo (once daily for 2 days) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cebranopadol 400 ug | Drug | Once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome Measure | Pain Numerical Rate Scale (NRS) area under the curve from 4 through 48 hours (AUC4-48) | 4-48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Outcome Measure: | Pain Numerical Rate Scale (NRS) AUC4-24 | 4-48 hours |
| Secondary Outcome Measure: | Number of doses of rescue medication |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harold S. Minkowitz, MD | HD Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ALLEVIATE 1 Site 001106 | Little Rock | Arkansas | 72211 | United States | ||
| ALLEVIATE 1 Site 001112 |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000589289 | 6'-fluoro-4',9'-dihydro-N,N-dimethyl-4-phenylspiro(cyclohexane-1,1'(3'H)-pyrano(3,4-b)indol)-4-amine |
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| Cebranopadol 200 ug | Drug | Once daily on Day 2 |
|
|
| Placebo | Drug | Once daily for 2 days |
|
| 48 hours |
| Secondary Outcome Measure: | Pain NRS AUC | 24-48 hours |
| Other Secondary Endpoint | Pain NRS | Partial AUCs: 4-12, 12-24, 24-36, 36-48, and 4-36 hours |
| Other Secondary Endpoint | Rescue Medication | Proportion of subjects who take at least 1 dose of rescue medication up to hours 12, 24, and 36 |
| Other Secondary Endpoint | MOAA/S | peak sedation, total score and AUC4-48 |
| Miami |
| Florida |
| 33014 |
| United States |
| ALLEVIATE 1 Site 001110 | Bellaire | Texas | 77401 | United States |
| ALLEVIATE 1 Site 001111 | San Antonio | Texas | 78240 | United States |