PainPhase 4NCT01982539

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

A Phase 4 study testing Zipsor® in people with Pain, run by Depomed at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

As part of the PREA(Pediatric Research Equity Act) commitment, the objective of the study is to confirm safety and tolerability of 25 mg of Zipsor® in clinical pediatric subjects. Read more about this study

Who is it for?: Ages 12 to 17 years
Conditions the study is for: Pain
What is being tested?: Zipsor®
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 2 sitesUnited States
Study dates: Nov 2013to Sep 2014
Phase: Phase 4
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 12 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Male and female subjects between 12-17 years of age.
Subjects must be post-op, having mild or moderate acute pain.
Other inclusions apply.

Who cannot join

Subject has a known history of allergic reaction, hypersensitivity to diclofenac, aspirin, acetaminophen, or reaction to the non-active ingredients of the study medication.
Subject has been taking analgesic for 48-72 hours prior to Screening.
Subject has a history of any GI event greater than 6 months before Screening.
Subject is currently receiving any medication that is contraindicated for use concomitantly with diclofenac or acetaminophen.
Subject has previously participated in another clinical study of Zipsor or taking Zipsor for any other indication.
Subject is requiring treatment for pre-existing hypertension.
Other exclusions apply.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Study site
Sheffield, Alabama, 35660
Study site
Stanford, California, 94305-5640

Other trials in United States

About this study

Official title: An Open-Label Study of the Safety and Efficacy of Zipsor® (Diclofenac Potassium) Liquid Filled Capsules in Pediatric Subjects (Ages 12-17 Years) With Mild to Moderate Acute Pain

As part of the PREA(Pediatric Research Equity Act) commitment, the objective of the study is to confirm safety and tolerability of 25 mg of Zipsor® in clinical pediatric subjects.

Read the detailed description

Open-label study, subjects will be dosed with Zipsor® for the treatment of mild to moderate acute pain for up to 4 days.

Conditions: Pain
Being tested: Zipsor®
Keywords: pain, NSAID, moderate pain, mild pain, acute pain, mild acute pain, moderate acute pain, mild or moderate acute pain
Medical subject headings: Pain, Acute Pain, Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Zipsor®Drug
Also called Diclofenac
Administration of Zipsor® (liquid filled capsules) to patients with mild to moderate acute pain: 25 mg/every 6 hours/up to 4 days treament. Drug taken by mouth.

Study groups in NCT01982539
Study group	Role	What they receive
Zipsor® (Liquid filled capsules)	Experimental	25mg/every 6hrs/up to 4 days treatment Receives: Drug: Zipsor®

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety and Tolerability of Zipsor® in Pediatric Subjects, Ages 12 to 17 Years
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
Measured: First dose to 30 days after the last dose

Secondary outcomes (2)

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.
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.
Measured: From Baseline to 1st and 2nd hour
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.
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.
Measured: From Baseline to 1st and 2nd hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2013Sep 2014

First posted13 Nov 2013 (estimated)
Study startNov 2013
Primary completionMay 2014
Study completionSep 2014

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 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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01982539
Sponsor's protocol ID: 81-0072
Status last verified: Apr 2020
First submitted: 1 Nov 2013
Last updated: 7 May 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label Study of the Safety and Efficacy of Zipsor® (Diclofenac Potassium) Liquid Filled Capsules in Pediatric Subjects (Ages 12-17 Years) With Mild to Moderate Acute Pain
ClinicalTrials.gov ID: NCT01982539
Acronym / sponsor ID: 81-0072
Conditions: Pain
Keywords: pain, NSAID, moderate pain, mild pain, acute pain, mild acute pain, moderate acute pain, mild or moderate acute pain
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: DepomedIndustry (pharma, biotech, devices)
Study start: Nov 2013
Primary completion: May 2014 (actual)
Study completion: Sep 2014 (actual)
First posted: 13 Nov 2013 (estimated)
Results: Posted 15 May 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

As part of the PREA(Pediatric Research Equity Act) commitment, the objective of the study is to confirm safety and tolerability of 25 mg of Zipsor® in clinical pediatric subjects.

Detailed description

Open-label study, subjects will be dosed with Zipsor® for the treatment of mild to moderate acute pain for up to 4 days.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Zipsor® (Liquid filled capsules)	Experimental	Drug: Zipsor®25mg/every 6hrs/up to 4 days treatment

Who may qualify

Ages: 12 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

Male and female subjects between 12-17 years of age.
Subjects must be post-op, having mild or moderate acute pain.
Other inclusions apply.

Key exclusion criteria (7 listed)

Subject has a known history of allergic reaction, hypersensitivity to diclofenac, aspirin, acetaminophen, or reaction to the non-active ingredients of the study medication.
Subject has been taking analgesic for 48-72 hours prior to Screening.
Subject has a history of any GI event greater than 6 months before Screening.
Subject is currently receiving any medication that is contraindicated for use concomitantly with diclofenac or acetaminophen.
Subject has previously participated in another clinical study of Zipsor or taking Zipsor for any other indication.

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
Zipsor®Also: DiclofenacAdministration of Zipsor® (liquid filled capsules) to patients with mild to moderate acute pain: 25 mg/every 6 hours/up to 4 days treament. Drug taken by mouth.	Drug	Zipsor® (Liquid filled capsules)

Primary outcome

Safety and Tolerability of Zipsor® in Pediatric Subjects, Ages 12 to 17 Years
Time frame: First dose to 30 days after the last dose
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

2 secondary outcomes

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.
Time frame: From Baseline to 1st and 2nd hour
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.
Time frame: From Baseline to 1st and 2nd hour

Results and safety

Results posted to the registry on 15 May 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Zipsor® (Liquid Filled Capsules)	25	25

Primary outcome: Safety and Tolerability of Zipsor® in Pediatric Subjects, Ages 12 to 17 Years

Time frame: First dose to 30 days after the last dose. Number. Unit: participants

Measure	Zipsor® (Liquid Filled Capsules) n = 25
Treatment-emergent adverse events (TEAEs)	12
Severe TEAEs	0
Serious TEAEs	1
Serious Adverse Events (SAEs)	1
Withdrawals due to AEs	0
Deaths	0

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

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Zipsor® (Liquid Filled Capsules)	1 of 25 (4%)	9 of 25 (36%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Zipsor® in people with Pain, run by Depomed at 2 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 3 inclusion and 7 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 7 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 15 May 2015). 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?

Safety and Tolerability of Zipsor® in Pediatric Subjects, Ages 12 to 17 Years (time frame: First dose to 30 days after the last dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01982539.

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 7 May 2020.