Trial Outcomes & Findings for Safety and Tolerability of Zipsor® in Pediatric Subjects (Ages 12-17 Years) With Mild to Moderate Acute (NCT NCT01982539)

Results Overview

Safety Endpoints: * Treatment emergent AEs (TEAEs) * Serious adverse events (SAEs) * Withdrawals due to AEs * Deaths * Observed values and changes in vital sign measurements * Observed values and changes in clinical laboratory results * Physical examination findings

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

25 participants

Primary outcome timeframe

First dose to 30 days after the last dose

Results posted on

2020-05-07

Participant Flow

Participant milestones

Participant milestones
Measure	Zipsor® (Liquid Filled Capsules) Administration of Zipsor® (liquid filled capsules) to patients with mild to moderate acute pain: 25 mg/every 6 hours/up to 4 days treatment. Drug taken by mouth.
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Tolerability of Zipsor® in Pediatric Subjects (Ages 12-17 Years) With Mild to Moderate Acute

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Zipsor® (Liquid Filled Capsules) n=25 Participants Administration of Zipsor® (liquid filled capsules) to patients with mild to moderate acute pain: 25 mg/every 6 hours/up to 4 days treatment. Drug taken by mouth.
Age, Continuous	14.9 years STANDARD_DEVIATION 1.38 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: First dose to 30 days after the last dose

Population: The Safety population included all subjects who received at least 1 dose of the study drug.

Safety Endpoints: * Treatment emergent AEs (TEAEs) * Serious adverse events (SAEs) * Withdrawals due to AEs * Deaths * Observed values and changes in vital sign measurements * Observed values and changes in clinical laboratory results * Physical examination findings

Outcome measures

Outcome measures
Measure	Zipsor® (Liquid Filled Capsules) n=25 Participants Administration of Zipsor® (liquid filled capsules) to subjects with mild to moderate acute pain: 25 mg/every 6 hours/up to 4 days treatment. Drug taken by mouth.
Safety and Tolerability of Zipsor® in Pediatric Subjects, Ages 12 to 17 Years Serious Adverse Events (SAEs)	1 participants
Safety and Tolerability of Zipsor® in Pediatric Subjects, Ages 12 to 17 Years Withdrawals due to AEs	0 participants
Safety and Tolerability of Zipsor® in Pediatric Subjects, Ages 12 to 17 Years Deaths	0 participants
Safety and Tolerability of Zipsor® in Pediatric Subjects, Ages 12 to 17 Years Treatment-emergent adverse events (TEAEs)	12 participants
Safety and Tolerability of Zipsor® in Pediatric Subjects, Ages 12 to 17 Years Severe TEAEs	0 participants
Safety and Tolerability of Zipsor® in Pediatric Subjects, Ages 12 to 17 Years Serious TEAEs	1 participants

SECONDARY outcome

Timeframe: From Baseline to 1st and 2nd hour

Population: Full Analysis Set are enrolled patients who had available valid NPRS scores recorded on Day 1, received at least 1 dose of Zipsor, and completed at least 1 postbaseline NPRS score with a valid score. The Full Analysis Set was the primary population for the efficacy analysis. Safety Analysis Set has n=25.

Numeric Pain Rating Scale (NPRS) measures the subject intensity of pain on an 11-point scale. 0 = No Pain, 10 = Worst Pain at baseline to (1) the first hour and (2) the second hour after the first dose of Zipsor® administration.

Outcome measures

Outcome measures
Measure	Zipsor® (Liquid Filled Capsules) n=23 Participants Administration of Zipsor® (liquid filled capsules) to subjects with mild to moderate acute pain: 25 mg/every 6 hours/up to 4 days treatment. Drug taken by mouth.
Changes in the Numeric Pain Rating Scale (NPRS) Pain Score From Baseline to (1) the First Hour and (2) the Second Hour After the First Dose of Zipsor® Administration. Baseline	4.1 score on a scale Standard Deviation 2.00
Changes in the Numeric Pain Rating Scale (NPRS) Pain Score From Baseline to (1) the First Hour and (2) the Second Hour After the First Dose of Zipsor® Administration. 1st Hour	2.0 score on a scale Standard Deviation 1.61
Changes in the Numeric Pain Rating Scale (NPRS) Pain Score From Baseline to (1) the First Hour and (2) the Second Hour After the First Dose of Zipsor® Administration. 2nd Hour	1.7 score on a scale Standard Deviation 1.77

SECONDARY outcome

Timeframe: From Baseline to 1st and 2nd hour

Population: Full Analysis Set are enrolled patients who had available valid NPRS scores recorded on Day 1, received at least 1 dose of Zipsor, and completed at least 1 postbaseline NPRS score with a valid score. The Full Analysis Set was the primary population for the efficacy analysis. Safety Analysis Set has n=25.

Numeric Pain Rating Scale (NPRS) measures the subject intensity of pain on an 11-point scale. 0 = No Pain, 10 = Worst Pain at baseline to (1) the first hour and (2) the second hour after the first dose of Zipsor® administration.

Outcome measures

Outcome measures
Measure	Zipsor® (Liquid Filled Capsules) n=23 Participants Administration of Zipsor® (liquid filled capsules) to subjects with mild to moderate acute pain: 25 mg/every 6 hours/up to 4 days treatment. Drug taken by mouth.
Percentage Difference of Numeric Pain Rating Scale (NPRS) Pain Score From Baseline to (1) the First Hour and (2) the Second Hour After the First Dose of Zipsor® Administration. Percent Change from baseline to 1 hour postdose	-55.32 Percent Change of NPRS Score Standard Deviation 24.899
Percentage Difference of Numeric Pain Rating Scale (NPRS) Pain Score From Baseline to (1) the First Hour and (2) the Second Hour After the First Dose of Zipsor® Administration. Percent Change from Baseline to 2 hours post dose	-60.25 Percent Change of NPRS Score Standard Deviation 41.549

Adverse Events

Zipsor® (Liquid Filled Capsules)

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Zipsor® (Liquid Filled Capsules) n=25 participants at risk Administration of Zipsor® (liquid filled capsules) to patients with mild to moderate acute pain: 25 mg/every 6 hours/up to 4 days treatment. Drug taken by mouth.
Injury, poisoning and procedural complications Post Procedural Bile Leak	4.0% 1/25

Other adverse events

Other adverse events
Measure	Zipsor® (Liquid Filled Capsules) n=25 participants at risk Administration of Zipsor® (liquid filled capsules) to patients with mild to moderate acute pain: 25 mg/every 6 hours/up to 4 days treatment. Drug taken by mouth.
Gastrointestinal disorders Nausea	20.0% 5/25
Gastrointestinal disorders Constipation	8.0% 2/25
Nervous system disorders Headache	8.0% 2/25

Additional Information

Clinical Operations

Depomed

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The PI agrees that sponsor shall have the right to the first publication of the study results which is intended to be a joint, multi-center publication. Following the first publication, the PI may publish study data or results, provided however PI submits the proposed publication to sponsor for review at least 60 days prior to the date of the proposed publication. Sponsor may remove any information that is considered confidential and / or proprietary other than study data.
Publication restrictions are in place

Restriction type: OTHER