Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06602271
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-16
Brief Title:
PF614 Analgesic Activity in Acute Postoperative Pain PF614-301
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Placebo- and Active-Controlled Study to Evaluate the Efficacy and Safety of PF614 for the Treatment of Moderate to Severe Pain After Abdominoplasty
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to evaluate the analgesic activity of PF614 an oral oxycodone prodrug extended-release analgesic for control of postsurgical pain in subjects scheduled for abdominoplasty surgery The main question to be answered is
To assess the analgesic efficacy of PF614 compared to oxycodone hydrochloride an immediate-release opioid analgesic and placebo in subjects with moderate to severe pain following abdominoplasty Participants will be asked to take oral blinded doses of study medication at about one hour before surgery starts and then every 6 hours after surgery for up to 4 days
Participants will be asked to
Rate their pain on a 0-10 numerical rating scale NRS at various timepoints up to 5 days following surgery
Tell us about the need for rescue medication if they continue to have moderate-to-severe pain
Tell us about any side effects or adverse effects that they may experience to help us understand the safety and tolerability of the test medications
Provide periodic blood samples to help us understand how much study drug is in their system
Participants will stay in a clinic setting and be monitored for safety for 5 days following surgery We anticipate that participants will be discharged on Day 5 pending medical review and then keep a diary to record study-related pain and adverse effects for an additional 2-4 days after discharge
To assess the analgesic efficacy of PF614 compared to oxycodone hydrochloride an immediate-release opioid analgesic and placebo in subjects with moderate to severe pain following abdominoplasty Participants will be asked to take oral blinded doses of study medication at about one hour before surgery starts and then every 6 hours after surgery for up to 4 days
Participants will be asked to
Rate their pain on a 0-10 numerical rating scale NRS at various timepoints up to 5 days following surgery
Tell us about the need for rescue medication if they continue to have moderate-to-severe pain
Tell us about any side effects or adverse effects that they may experience to help us understand the safety and tolerability of the test medications
Provide periodic blood samples to help us understand how much study drug is in their system
Participants will stay in a clinic setting and be monitored for safety for 5 days following surgery We anticipate that participants will be discharged on Day 5 pending medical review and then keep a diary to record study-related pain and adverse effects for an additional 2-4 days after discharge
Detailed Description:
This will be a Phase 3 multicenter randomized double-blind placebo- and active-controlled study to evaluate the efficacy and safety of PF614 in the treatment of moderate-to-severe pain following abdominoplasty The study will be conducted in 4 phases Screening Treatment Outpatient and Follow-up Study assessments will be performed at the visits and time points outlined in the Schedule of Assessments
Screening Phase Eligible participants will complete a standard medical screening within 28 days of the abdominoplasty procedure At Screening participants will provide written informed consent to participate in the study before any protocol-specified procedures or assessments are conducted
Treatment Phase The Treatment Phase will begin on the day of the abdominoplasty procedure Day 1 and will end on postoperative Day 5 Participants will be admitted to the study center on the morning of the scheduled procedure and will be confined throughout the Treatment Phase 5 days 4 nights
Days 1-4 0-72 hours Randomized Treatment Period Following admission to the study center presurgical procedures will include participant training on pain intensity and nausea assessments which will both be administered as 11 point numerical rating scales NRS Participants who continue to meet all study entry criteria will be randomized prior to the abdominoplasty procedure in a 11111 ratio to 1 of 5 treatment groups
Treatment groups will include the following doses PF614 25 mg PF614 375 mg PF614 50 mg Oxycodone HCl 10 mg and Placebo
The first dose of study drug will be administered approximately 1 hour prior to the abdominoplasty procedure Time 0 is defined as the time of first study drug administration Additional doses of study drug will be provided every 6 hours with the last scheduled study drug administration at 72 hours Qualified medical personnel andor investigators who are ACLS Advanced Cardiovascular Life Support certified will be present in the clinic during the inpatient treatment phase when participants are administered opioid medications
Participants will undergo a full abdominoplasty procedure without liposuction or other collateral procedures under a standardized anesthetic protocol Prior to wound closure the surgeon will perform a local anesthetic field block by infiltrating 15 lidocaine with epinephrine 7 mgkg with a maximum dose of 500 mg Participants will be administered supplemental oxygen for at least the first 2 hours postoperatively and the participant will be weaned as clinically appropriate Subsequently if oxygen is required beyond 4 hours postoperatively this will be considered a respiratory-related adverse event AE and the use of supplemental oxygen will be documented as a concomitant medication
A graduated rescue medication protocol will be implemented such that participants may receive ibuprofen 400 mg every 4 to 6 hours up to a maximum of 2400 mg24 hours as the first line rescue medication if needed Participants who receive ibuprofen will not be permitted to receive additional ibuprofen for a minimum of 4 hours lockout period In cases where ibuprofen does not provide adequate pain relief within approximately 1 hour of administration participants may receive hydrocodoneacetaminophen APAP HCAPAP 5 mg325 mg as a second line rescue medication up to a maximum of 20 mg1300 mg every 24 hours If HCAPAP is administered participants will not be eligible to receive additional HCAPAP for the following 4 hours but may be permitted to receive additional ibuprofen provided that they are not still within an ibuprofen lockout period
Pain intensity 11-point NRS assessments at rest NRS-R minimum 15-minute rest and with movement NRS-A where movement is defined as moving from a supine to sitting position will be recorded at scheduled times during the inpatient period after Time 0 and immediately before each use of rescue medication Study drug will be administered after assessment of pain at each timepoint when dosing and pain assessments overlap During the night participants will be wakened to administer the study drug Pain assessments will be performed throughout the night when participants are awake however sleeping participants will not be awakened for assessments during a designated period of 6 consecutive hours Pain intensity will also be recorded before early study discontinuation Blood will be collected for pharmacokinetic PK analysis and participant-rated assessments of nausea using an 11-point NRS and observer rated assessments of sedation using the Modified Observers Assessment of AlertnessSedation Scale MOAAS will be conducted at pre-specified timepoints Participants will complete a Global Assessment of Satisfaction with Study Treatment at 84 2 hours or early discontinuation
Days 4-5 72-96 hours Predischarge Period Participants will remain inpatient for approximately 24 hours after the last scheduled study drug administration During this period participants may be administered ibuprofen and HCAPAP for pain relief using the same dosing regimen as the graduated rescue medication protocol described above Pain intensity PK and safety assessments will be conducted at pre-specified timepoints until discharge on Day 5 96 hours
Outpatient and Follow-up Phases Before discharge from the study center study personnel will dispense a prescription for pain medication if necessary and an outpatient participant diary Participants will be instructed to complete the Brief Pain Inventory BPI Short Form at the end of each day during the Outpatient Phase and record use of any concomitant medications and AEs experienced after discharge in their electronic outpatient participant diary Participants will be instructed to return the outpatient participant diary to study personnel at the Follow up-Visit scheduled to occur 7 to 9 days after the abdominoplasty procedure
Screening Phase Eligible participants will complete a standard medical screening within 28 days of the abdominoplasty procedure At Screening participants will provide written informed consent to participate in the study before any protocol-specified procedures or assessments are conducted
Treatment Phase The Treatment Phase will begin on the day of the abdominoplasty procedure Day 1 and will end on postoperative Day 5 Participants will be admitted to the study center on the morning of the scheduled procedure and will be confined throughout the Treatment Phase 5 days 4 nights
Days 1-4 0-72 hours Randomized Treatment Period Following admission to the study center presurgical procedures will include participant training on pain intensity and nausea assessments which will both be administered as 11 point numerical rating scales NRS Participants who continue to meet all study entry criteria will be randomized prior to the abdominoplasty procedure in a 11111 ratio to 1 of 5 treatment groups
Treatment groups will include the following doses PF614 25 mg PF614 375 mg PF614 50 mg Oxycodone HCl 10 mg and Placebo
The first dose of study drug will be administered approximately 1 hour prior to the abdominoplasty procedure Time 0 is defined as the time of first study drug administration Additional doses of study drug will be provided every 6 hours with the last scheduled study drug administration at 72 hours Qualified medical personnel andor investigators who are ACLS Advanced Cardiovascular Life Support certified will be present in the clinic during the inpatient treatment phase when participants are administered opioid medications
Participants will undergo a full abdominoplasty procedure without liposuction or other collateral procedures under a standardized anesthetic protocol Prior to wound closure the surgeon will perform a local anesthetic field block by infiltrating 15 lidocaine with epinephrine 7 mgkg with a maximum dose of 500 mg Participants will be administered supplemental oxygen for at least the first 2 hours postoperatively and the participant will be weaned as clinically appropriate Subsequently if oxygen is required beyond 4 hours postoperatively this will be considered a respiratory-related adverse event AE and the use of supplemental oxygen will be documented as a concomitant medication
A graduated rescue medication protocol will be implemented such that participants may receive ibuprofen 400 mg every 4 to 6 hours up to a maximum of 2400 mg24 hours as the first line rescue medication if needed Participants who receive ibuprofen will not be permitted to receive additional ibuprofen for a minimum of 4 hours lockout period In cases where ibuprofen does not provide adequate pain relief within approximately 1 hour of administration participants may receive hydrocodoneacetaminophen APAP HCAPAP 5 mg325 mg as a second line rescue medication up to a maximum of 20 mg1300 mg every 24 hours If HCAPAP is administered participants will not be eligible to receive additional HCAPAP for the following 4 hours but may be permitted to receive additional ibuprofen provided that they are not still within an ibuprofen lockout period
Pain intensity 11-point NRS assessments at rest NRS-R minimum 15-minute rest and with movement NRS-A where movement is defined as moving from a supine to sitting position will be recorded at scheduled times during the inpatient period after Time 0 and immediately before each use of rescue medication Study drug will be administered after assessment of pain at each timepoint when dosing and pain assessments overlap During the night participants will be wakened to administer the study drug Pain assessments will be performed throughout the night when participants are awake however sleeping participants will not be awakened for assessments during a designated period of 6 consecutive hours Pain intensity will also be recorded before early study discontinuation Blood will be collected for pharmacokinetic PK analysis and participant-rated assessments of nausea using an 11-point NRS and observer rated assessments of sedation using the Modified Observers Assessment of AlertnessSedation Scale MOAAS will be conducted at pre-specified timepoints Participants will complete a Global Assessment of Satisfaction with Study Treatment at 84 2 hours or early discontinuation
Days 4-5 72-96 hours Predischarge Period Participants will remain inpatient for approximately 24 hours after the last scheduled study drug administration During this period participants may be administered ibuprofen and HCAPAP for pain relief using the same dosing regimen as the graduated rescue medication protocol described above Pain intensity PK and safety assessments will be conducted at pre-specified timepoints until discharge on Day 5 96 hours
Outpatient and Follow-up Phases Before discharge from the study center study personnel will dispense a prescription for pain medication if necessary and an outpatient participant diary Participants will be instructed to complete the Brief Pain Inventory BPI Short Form at the end of each day during the Outpatient Phase and record use of any concomitant medications and AEs experienced after discharge in their electronic outpatient participant diary Participants will be instructed to return the outpatient participant diary to study personnel at the Follow up-Visit scheduled to occur 7 to 9 days after the abdominoplasty procedure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None