Evaluate the Efficacy and Safety of ACP-044 for the Treatment of Acute Postoperative Pain Following Bunionectomy
Study Details
Study Description
Brief Summary
To evaluate the efficacy of ACP-044 compared with placebo in the treatment of acute postoperative pain
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Drug - ACP-044 Dose A ACP-044 Dose A |
Drug: ACP-044 Dose A
Oral dose of ACP-044 Dose A
|
| Experimental: Drug - ACP-044 Dose B ACP-044 Dose B |
Drug: ACP-044 Dose B
Oral dose of ACP-044 Dose B
|
| Placebo Comparator: Placebo Placebo |
Drug: Placebo
Oral dose of placebo
|
Outcome Measures
Primary Outcome Measures
- Mean area under the curve (AUC) of the Numeric Rating Scale (NRS) of pain intensity scores from time 0 (when first dose on Day 1 is administered) through 24 hours for ACP-044 [0-24 hours]
Secondary Outcome Measures
- Time to first rescue medication use after time 0 (when first dose on Day 1 is administered) [0-72 hours]
- Proportion of subjects who were opioid free through 24, 48, and 72 hours [0-24, 0-48, 0-72 hours]
- Mean AUC of the NRS of pain intensity scores from time 0 through 48 and 72 hours for ACP-044 [0-48, 0-72 hours]
- Mean AUC of the NRS of pain intensity scores from time 0 through 4, 6, and 12 hours, 24-48 hours, and 48-72 hours for ACP-044 [0-4, 0-6, 0-12, 24-48, 48-72 hours]
- Amount of rescue medication taken during 0-24, 24-48, and 48-72 hours (individually), 0-48 hours, and 0-72 hours [0-24, 24-48, 48-72, 0-48, 0-72 hours]
- Proportion of subjects who did not use rescue medication through 24, 48, and 72 hours [0-24, 0-48, 0-72 hours]
- Proportion of subjects who are pain free (NRS ≤2) at 24, 48, and 72 hours [0-24, 0-48, 0-72 hours]
- Number of hours subjects are pain free (NRS ≤2) [72 hours]
- Proportion of subjects who were opioid free during 24, 48 hours and 48-72 hours [0-24, 48-72, 0-48 hours]
- Subject reported degree of pain control over the preceding interval according to a 5 point scale [0-24, 0-48, 0-72 hours]
5 point scale (0-4) with categories of 0-poor, 1-fair, 2-good, 3-very good, or 4-excellent
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or female ≥18 and <60 years of age at the time of Screening
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Has a body mass index (BMI) <40 kg/m2
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Able to understand and provide signed informed consent
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Able to complete subject-reported outcome measures
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Is in need of a primary unilateral, first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia and sedation
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Willing to remain inpatient at the study center for 4 days following surgery
Exclusion Criteria:
-
Has had a contralateral foot bunionectomy in the past 3 months
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Has a planned concurrent surgical procedure (e.g. bilateral bunionectomy or collateral procedures like hammertoe correction on the surgical foot)
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Any subacute or chronic pain condition or use of a medication that would impair/impact the ability to rate the pain associated with the bunionectomy, in the opinion of the Investigator and Medical Monitor
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Has known or suspected regular use of opioids within the previous 6 months
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Has taken opioids within 24 hours prior to the scheduled surgery or within five half-lives of the drug, whichever is longer
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Has a known or suspected history of drug abuse, a positive drug screen at Screening or Day -1, or a recent (i.e., within the last 5 years) history of alcohol abuse. Subjects using marijuana are not allowed to participate in the study.
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Has taken any aspirin (ASA) or non-steroidal anti-inflammatory drugs (NSAIDs) within 2 days prior to the scheduled surgery or within five half-lives of the drug, whichever is longer
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Has initiated treatment with any medications within 1 month prior to study drug administration that could impact pain control or quantitation of their pain response
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Has been administered systemic steroids within five half-lives or 10 days prior to administration of study drug, whichever is longer
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Has current evidence, or medical history of a serious and/or unstable psychiatric, neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, endocrinologic, or other medical disorder, within the previous 12 weeks prior to Screening and on Day -1, that in the judgment of the Investigator and/or Medical Monitor would jeopardize the safe participation of the subject in the study. Also, subject must not have had a malignancy in the last year, with the exception of nonmetastatic basal cell of the skin or localized carcinoma in situ of the cervix.
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Is judged by the Investigator or the Medical Monitor to be inappropriate for the study
Additional inclusion/exclusion criteria apply. Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically, if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Anaheim Clinical Trials | Anaheim | California | United States | 92801 |
| 2 | Chesapeake Ambulatory Surgery Center | Pasadena | Maryland | United States | 21122 |
| 3 | Endeavor Clinical Trials of San Antonio, TX | San Antonio | Texas | United States | 78229 |
| 4 | JBR Cinical Research | Salt Lake City | Utah | United States | 84107 |
Sponsors and Collaborators
- ACADIA Pharmaceuticals Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ACP-044-004