Acute Postoperative PainPhase 2NCT04855240
Evaluate the Efficacy and Safety of ACP-044 for the Treatment of Acute Postoperative Pain Following Bunionectomy
A Phase 2 study testing ACP-044 Dose A and ACP-044 Dose B in people with Acute Postoperative Pain and Bunionectomy, run by ACADIA Pharmaceuticals Inc. at 4 sites in United States.
Trial summary
To evaluate the efficacy of ACP-044 compared with placebo in the treatment of acute postoperative pain Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Postoperative Pain, Bunionectomy
- What is being tested?
- ACP-044 Dose A and ACP-044 Dose B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 239 participants
- Where
- 4 sitesUnited States
- Study dates
- 29 Mar 2021to 14 Mar 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥18 and <60 years of age at the time of Screening
- Has a body mass index (BMI) <40 kg/m2
- Able to understand and provide signed informed consent
- Able to complete subject-reported outcome measures
- Is in need of a primary unilateral, first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia and sedation
- Willing to remain inpatient at the study center for 4 days following surgery
Who cannot join
- Has had a contralateral foot bunionectomy in the past 3 months
- Has a planned concurrent surgical procedure (e.g. bilateral bunionectomy or collateral procedures like hammertoe correction on the surgical foot)
- 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
- Has known or suspected regular use of opioids within the previous 6 months
- Has taken opioids within 24 hours prior to the scheduled surgery or within five half-lives of the drug, whichever is longer
- 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.
Show all 12Show fewer
- 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
- 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
- Has been administered systemic steroids within five half-lives or 10 days prior to administration of study drug, whichever is longer
- 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.
- 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).
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Anaheim Clinical Trials
Anaheim, California, 92801
Chesapeake Ambulatory Surgery Center
Pasadena, Maryland, 21122
JBR Cinical Research
Salt Lake City, Utah, 84107
Endeavor Clinical Trials of San Antonio, TX
San Antonio, Texas, 78229
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ACP-044 for Acute Postoperative Pain Following Orthopedic Surgery (Bunionectomy)
To evaluate the efficacy of ACP-044 compared with placebo in the treatment of acute postoperative pain
- Conditions
- Acute Postoperative Pain, Bunionectomy
- Being tested
- ACP-044 Dose A, ACP-044 Dose B, Placebo
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACP-044 Dose ADrug
Oral dose of ACP-044 Dose A
ACP-044 Dose BDrug
Oral dose of ACP-044 Dose B
PlaceboDrug
Oral dose of placebo
| Study group | Role | What they receive |
|---|---|---|
| Drug - ACP-044 Dose A | Experimental | ACP-044 Dose A Receives: Drug: ACP-044 Dose A |
| Drug - ACP-044 Dose B | Experimental | ACP-044 Dose B Receives: Drug: ACP-044 Dose B |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Pain (efficacy) assessments were recorded hourly (±15 minutes) for a 12-hour interval on Day 1 beginning immediately prior to the fifth dose (time 0) administered in the study. Pain assessments were continued every 3 hours during the subsequent 12 hour interval, and then every 6 hours thereafter until 72 hours, then once daily in the morning until the follow-up clinical visit. Pain assessments were also obtained immediately prior to the administration of rescue medication.
A 0 to 10 Numeric Rating Scale of Pain Intensity (NRS) was used to assess the subject's pain.
Subjects were asked: "Please describe your foot pain at the present time from 0 to 10 where "0" means "no pain at all" and "10" means "the worst pain imaginable." The area under the curve is generated using the following timepoints beginning immediately prior to the fifth dose (time 0): 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 15, 18, 21, and 24 hours.
Measured: 0-24 hours
Secondary outcomes (29)
Time to First Rescue Medication Use After Time 0 (When First Dose on Day 1 is Administered)
Measured: 0-72 hours
Proportion of Subjects Who Were Opioid Free Through 24 Hours
Measured: 0-24 hours
Proportion of Subjects Who Were Opioid Free Through 48 Hours
Measured: 0-48 hours
Proportion of Subjects Who Were Opioid Free Through 72 Hours
Measured: 0-72 hours
Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 48 Hours for ACP-044
Pain (efficacy) assessments were recorded hourly (±15 minutes) for a 12-hour interval on Day 1 beginning immediately prior to the fifth dose (time 0) administered in the study. Pain assessments were continued every 3 hours during the subsequent 12 hour interval, and then every 6 hours thereafter until 72 hours, then once daily in the morning until the follow-up clinical visit. Pain assessments were also obtained immediately prior to the administration of rescue medication.
A 0 to 10 Numeric Rating Scale of Pain Intensity (NRS) was used to assess the subject's pain.
Subjects were asked: "Please describe your foot pain at the present time from 0 to 10 where "0" means "no pain at all" and "10" means "the worst pain imaginable." The area under the curve is generated using the following timepoints beginning immediately prior to the fifth dose (time 0): 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 15, 18, 21, 24, 30, 36, 42, and 48 hours.
Measured: 0-48 hours
Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 72 Hours for ACP-044
Pain (efficacy) assessments were recorded hourly (±15 minutes) for a 12-hour interval on Day 1 beginning immediately prior to the fifth dose (time 0) administered in the study. Pain assessments were continued every 3 hours during the subsequent 12 hour interval, and then every 6 hours thereafter until 72 hours, then once daily in the morning until the follow-up clinical visit. Pain assessments were also obtained immediately prior to the administration of rescue medication.
A 0 to 10 Numeric Rating Scale of Pain Intensity (NRS) was used to assess the subject's pain.
Subjects were asked: "Please describe your foot pain at the present time from 0 to 10 where "0" means "no pain at all" and "10" means "the worst pain imaginable." The area under the curve is generated using the following timepoints beginning immediately prior to the fifth dose (time 0): 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, and 72 hours.
Measured: 0-72 hours
Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 4 Hours for ACP-044
Pain (efficacy) assessments were recorded hourly (±15 minutes) for a 12-hour interval on Day 1 beginning immediately prior to the fifth dose (time 0) administered in the study. Pain assessments were continued every 3 hours during the subsequent 12 hour interval, and then every 6 hours thereafter until 72 hours, then once daily in the morning until the follow-up clinical visit. Pain assessments were also obtained immediately prior to the administration of rescue medication.
A 0 to 10 Numeric Rating Scale of Pain Intensity (NRS) was used to assess the subject's pain.
Subjects were asked: "Please describe your foot pain at the present time from 0 to 10 where "0" means "no pain at all" and "10" means "the worst pain imaginable." The area under the curve is generated using the following timepoints beginning immediately prior to the fifth dose (time 0): 0, 1, 2, 3, and 4 hours.
Measured: 0-4 hours
Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 6 Hours for ACP-044
Pain (efficacy) assessments were recorded hourly (±15 minutes) for a 12-hour interval on Day 1 beginning immediately prior to the fifth dose (time 0) administered in the study. Pain assessments were continued every 3 hours during the subsequent 12 hour interval, and then every 6 hours thereafter until 72 hours, then once daily in the morning until the follow-up clinical visit. Pain assessments were also obtained immediately prior to the administration of rescue medication.
A 0 to 10 Numeric Rating Scale of Pain Intensity (NRS) was used to assess the subject's pain.
Subjects were asked: "Please describe your foot pain at the present time from 0 to 10 where "0" means "no pain at all" and "10" means "the worst pain imaginable." The area under the curve is generated using the following timepoints beginning immediately prior to the fifth dose (time 0): 0, 1, 2, 3, 4, 5, and 6 hours.
Measured: 0-6 hours
Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 12 Hours for ACP-044
Pain (efficacy) assessments were recorded hourly (±15 minutes) for a 12-hour interval on Day 1 beginning immediately prior to the fifth dose (time 0) administered in the study. Pain assessments were continued every 3 hours during the subsequent 12 hour interval, and then every 6 hours thereafter until 72 hours, then once daily in the morning until the follow-up clinical visit. Pain assessments were also obtained immediately prior to the administration of rescue medication.
A 0 to 10 Numeric Rating Scale of Pain Intensity (NRS) was used to assess the subject's pain.
Subjects were asked: "Please describe your foot pain at the present time from 0 to 10 where "0" means "no pain at all" and "10" means "the worst pain imaginable." The area under the curve is generated using the following timepoints beginning immediately prior to the fifth dose (time 0): 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours.
Measured: 0-12 hours
Mean AUC of the NRS of Pain Intensity Scores From 24 Through 48 Hours for ACP-044
Pain (efficacy) assessments were recorded hourly (±15 minutes) for a 12-hour interval on Day 1 beginning immediately prior to the fifth dose (time 0) administered in the study. Pain assessments were continued every 3 hours during the subsequent 12 hour interval, and then every 6 hours thereafter until 72 hours, then once daily in the morning until the follow-up clinical visit. Pain assessments were also obtained immediately prior to the administration of rescue medication.
A 0 to 10 Numeric Rating Scale of Pain Intensity (NRS) was used to assess the subject's pain.
Subjects were asked: "Please describe your foot pain at the present time from 0 to 10 where "0" means "no pain at all" and "10" means "the worst pain imaginable." The area under the curve is generated using the following timepoints beginning immediately prior to the fifth dose (time 0): 24, 30, 36, 42, and 48 hours.
Measured: 24-48 hours
Mean AUC of the NRS of Pain Intensity Scores From Time 48 Through 72 Hours for ACP-044
Pain (efficacy) assessments were recorded hourly (±15 minutes) for a 12-hour interval on Day 1 beginning immediately prior to the fifth dose (time 0) administered in the study. Pain assessments were continued every 3 hours during the subsequent 12 hour interval, and then every 6 hours thereafter until 72 hours, then once daily in the morning until the follow-up clinical visit. Pain assessments were also obtained immediately prior to the administration of rescue medication.
A 0 to 10 Numeric Rating Scale of Pain Intensity (NRS) was used to assess the subject's pain.
Subjects were asked: "Please describe your foot pain at the present time from 0 to 10 where "0" means "no pain at all" and "10" means "the worst pain imaginable." The area under the curve is generated using the following timepoints beginning immediately prior to the fifth dose (time 0): 48, 54, 60, 66, and 72 hours.
Measured: 48-72 hours
Rescue Medication Taken During 0-24 Hours
Number of instances of rescue medication taken during first 24 hours.
Measured: 0-24 hours
Rescue Medication Taken During 24-48 Hours
Number of instances of rescue medication taken during 24-48 hours.
Measured: 24-48 hours
Rescue Medication Taken During 48-72 Hours
Number of instances of rescue medication taken during 48-72 hours.
Measured: 48-72 hours
Rescue Medication Taken During 0-48 Hours
Number of instances of rescue medication taken during first 48 hours.
Measured: 0-48 hours
Rescue Medication Taken During 0-72 Hours
Number of instances of rescue medication taken during first 72 hours.
Measured: 0-72 hours
Proportion of Subjects Who Did Not Use Rescue Medication Through 24 Hours
Measured: 0-24 hours
Proportion of Subjects Who Did Not Use Rescue Medication Through 48 Hours
Measured: 0-48 hours
Proportion of Subjects Who Did Not Use Rescue Medication Through 72 Hours
Measured: 0-72 Hours
Proportion of Subjects Who Are Pain Free (NRS ≤2) at 24 Hours
Measured: 0-24 hours
Proportion of Subjects Who Are Pain Free (NRS ≤2) at 48 Hours
Measured: 0-48 hours
Proportion of Subjects Who Are Pain Free (NRS ≤2) at 72 Hours
Measured: 0-72 hours
Number of Hours Subjects Are Pain Free (NRS ≤2)
Measured: 0-72 hours
Proportion of Subjects Who Were Opioid Free During 24-48 Hours
Measured: 24-48 hours
Proportion of Subjects Who Were Opioid Free During 48-72 Hours
Measured: 48-72 hours
Global Evaluation of Study Drug Just Before Time of First Rescue Medication Relative to Time 0 (When First Dose on Day 1 is Administered)
5 point scale (0-4) with categories of 0-poor, 1-fair, 2-good, 3-very good, or 4-excellent
Measured: First rescue medication dose, up to 24 hours post first dose.
Global Evaluation of Study Drug at the End of 24 Hours Relative to Time 0 (When First Dose on Day 1 is Administered)
5 point scale (0-4) with categories of 0-poor, 1-fair, 2-good, 3-very good, or 4-excellent
Measured: 24 hours
Global Evaluation of Study Drug at the End of 48 Hours Relative to Time 0 (When First Dose on Day 1 is Administered)
5 point scale (0-4) with categories of 0-poor, 1-fair, 2-good, 3-very good, or 4-excellent
Measured: 48 hours
Global Evaluation of Study Drug at the End of 72 Hours Relative to Time 0 (When First Dose on Day 1 is Administered)
5 point scale (0-4) with categories of 0-poor, 1-fair, 2-good, 3-very good, or 4-excellent
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start29 Mar 2021
- Primary completion11 Feb 2022
- Study completion14 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- ACADIA Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04855240
- Sponsor's protocol ID
- ACP-044-004
- Status last verified
- Feb 2023
- First submitted
- 19 Apr 2021
- Last updated
- 3 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ACP-044 for Acute Postoperative Pain Following Orthopedic Surgery (Bunionectomy)
- ClinicalTrials.gov ID
- NCT04855240
- Acronym / sponsor ID
- ACP-044-004
- Conditions
- Acute Postoperative Pain, Bunionectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- ACADIA Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 11 Feb 2022 (actual)
- Study completion
- 14 Mar 2022 (actual)
- First posted
- 22 Apr 2021 (actual)
- Results
- Posted 3 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy of ACP-044 compared with placebo in the treatment of acute postoperative pain
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Drug - ACP-044 Dose A | Experimental | Drug: ACP-044 Dose AACP-044 Dose A |
| Drug - ACP-044 Dose B | Experimental | Drug: ACP-044 Dose BACP-044 Dose B |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female ≥18 and <60 years of age at the time of Screening
- Has a body mass index (BMI) <40 kg/m2
- Able to understand and provide signed informed consent
- Able to complete subject-reported outcome measures
- Is in need of a primary unilateral, first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia and sedation
Key exclusion criteria (12 listed)
- Has had a contralateral foot bunionectomy in the past 3 months
- Has a planned concurrent surgical procedure (e.g. bilateral bunionectomy or collateral procedures like hammertoe correction on the surgical foot)
- 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
- Has known or suspected regular use of opioids within the previous 6 months
- Has taken opioids within 24 hours prior to the scheduled surgery or within five half-lives of the drug, whichever is longer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACP-044 Dose AOral dose of ACP-044 Dose A | Drug | Drug - ACP-044 Dose A |
| ACP-044 Dose BOral dose of ACP-044 Dose B | Drug | Drug - ACP-044 Dose B |
| PlaceboOral dose of placebo | Drug | Placebo |
Primary outcome
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
Time frame: 0-24 hours
Pain (efficacy) assessments were recorded hourly (±15 minutes) for a 12-hour interval on Day 1 beginning immediately prior to the fifth dose (time 0) administered in the study. Pain assessments were continued every 3 hours during the subsequent 12 hour interval, and then every 6 hours thereafter until 72 hours, then once daily in the morning until the follow-up clinical visit. Pain assessments were also obtained immediately prior to the administration of rescue medication. A 0 to 10 Numeric Rating Scale of Pain Intensity (NRS) was used to assess the subject's pain. Subjects were asked: "Please describe your foot pain at the present time from 0 to 10 where "0" means "no pain at all" and "10" means "the worst pain imaginable." The area under the curve is generated using the following timepoints beginning immediately prior to the fifth dose (time 0): 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 15, 18, 21, and 24 hours.
29 secondary outcomes
Time to First Rescue Medication Use After Time 0 (When First Dose on Day 1 is Administered)
Time frame: 0-72 hours
Proportion of Subjects Who Were Opioid Free Through 24 Hours
Time frame: 0-24 hours
Proportion of Subjects Who Were Opioid Free Through 48 Hours
Time frame: 0-48 hours
Proportion of Subjects Who Were Opioid Free Through 72 Hours
Time frame: 0-72 hours
Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 48 Hours for ACP-044
Time frame: 0-48 hours
Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 72 Hours for ACP-044
Time frame: 0-72 hours
Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 4 Hours for ACP-044
Time frame: 0-4 hours
Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 6 Hours for ACP-044
Time frame: 0-6 hours
Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 12 Hours for ACP-044
Time frame: 0-12 hours
Mean AUC of the NRS of Pain Intensity Scores From 24 Through 48 Hours for ACP-044
Time frame: 24-48 hours
Mean AUC of the NRS of Pain Intensity Scores From Time 48 Through 72 Hours for ACP-044
Time frame: 48-72 hours
Rescue Medication Taken During 0-24 Hours
Time frame: 0-24 hours
Rescue Medication Taken During 24-48 Hours
Time frame: 24-48 hours
Rescue Medication Taken During 48-72 Hours
Time frame: 48-72 hours
Rescue Medication Taken During 0-48 Hours
Time frame: 0-48 hours
Rescue Medication Taken During 0-72 Hours
Time frame: 0-72 hours
Proportion of Subjects Who Did Not Use Rescue Medication Through 24 Hours
Time frame: 0-24 hours
Proportion of Subjects Who Did Not Use Rescue Medication Through 48 Hours
Time frame: 0-48 hours
Proportion of Subjects Who Did Not Use Rescue Medication Through 72 Hours
Time frame: 0-72 Hours
Proportion of Subjects Who Are Pain Free (NRS ≤2) at 24 Hours
Time frame: 0-24 hours
Proportion of Subjects Who Are Pain Free (NRS ≤2) at 48 Hours
Time frame: 0-48 hours
Proportion of Subjects Who Are Pain Free (NRS ≤2) at 72 Hours
Time frame: 0-72 hours
Number of Hours Subjects Are Pain Free (NRS ≤2)
Time frame: 0-72 hours
Proportion of Subjects Who Were Opioid Free During 24-48 Hours
Time frame: 24-48 hours
Proportion of Subjects Who Were Opioid Free During 48-72 Hours
Time frame: 48-72 hours
Global Evaluation of Study Drug Just Before Time of First Rescue Medication Relative to Time 0 (When First Dose on Day 1 is Administered)
Time frame: First rescue medication dose, up to 24 hours post first dose.
Global Evaluation of Study Drug at the End of 24 Hours Relative to Time 0 (When First Dose on Day 1 is Administered)
Time frame: 24 hours
Global Evaluation of Study Drug at the End of 48 Hours Relative to Time 0 (When First Dose on Day 1 is Administered)
Time frame: 48 hours
Global Evaluation of Study Drug at the End of 72 Hours Relative to Time 0 (When First Dose on Day 1 is Administered)
Time frame: 72 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ACP-044 Dose A and ACP-044 Dose B in people with Acute Postoperative Pain and Bunionectomy, run by ACADIA Pharmaceuticals Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 0-24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.