Pain, PostoperativePhase 3NCT03429400
Study of Oral Morphine Sulfate Administration in Pediatric Subjects
A Phase 3 study testing Morphine Sulfate in people with Pain, Postoperative, run by West-Ward Pharmaceutical at 1 site in United States.
Trial summary
This is a multicenter, open-label study to evaluate the safety and PK of oral morphine sulfate in pediatric subjects with post-operative pain. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Morphine Sulfate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2018to 29 May 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Has a parent or guardian providing written parental permission/informed consent, with subject assent (if required by local IRB).
- Has an age-appropriate pain score of ≥4 prior to receiving first dose of study drug.
- Is a child 2 years old through 17 years old, inclusive (at the time of informed consent signing).
- Weighs at least 10 kg.
- Has a routine pediatric procedure that is expected to require inpatient hospitalization postoperatively.
- Must be an inpatient for the study treatment period.
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- Is expected by the investigator to have moderate to severe postoperative pain requiring the use of oral opioids for treatment.
- Has the ability to read and understand the study procedures and has the ability to communicate meaningfully with the study investigator and staff (if the subject is of preverbal age or cannot read or communicate meaningfully, then the subject's parent or guardian must meet this criterion).
- Is able to tolerate oral medications within 48 hours of surgery.
- If female subject is of childbearing potential, she must have a negative urine pregnancy test result on the day of surgery prior to surgery. In this population, female of childbearing potential is defined by the onset of menarche, ie, menstruation, whether at irregular or regular intervals (periods).
- Female subjects of childbearing potential and male subjects with partners capable of reproduction must agree to use an effective contraceptive method as follows from the time of Screening through 30 days after the last dose of study drug:
- A highly effective method of contraception, including hormonal contraceptives (eg, combined oral contraceptives, patch, vaginal ring, injectables, and implants), intrauterine device or intrauterine system OR
- An effective double-barrier contraceptive method (2 of the following: male condom, female condom, cervical cap, diaphragm, or contraceptive sponge) OR
- Abstinence
- Must have vascular access to facilitate blood draws.
Who cannot join
- Has significant medical disease(s), laboratory abnormalities, or conditions(s) that in the investigator's judgment could compromise the subject's welfare, ability to communicate with study staff, complete study activities, or would otherwise contraindicate study participation. There is no minimum value for SpO2 for inclusion in the study; this should be based on the investigator's judgment.
- Has used opioids chronically (eg, codeine, morphine, oxycodone, or hydromorphone), for >7 calendar days within the previous 30 days prior to surgery.
- Has received codeine, hydrocodone, morphine or oxycodone in any form in the previous 7 calendar days prior to surgery.
- Is undergoing procedure for treatment of acute burns.
- Has known hypersensitivity or contraindication to receiving oral opioid(s).
- Has a current active enteral malabsorption disorder.
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- Has impaired liver function (eg, alanine aminotransferase [ALT] ≥3 times the upper limit of normal [ULN], or total bilirubin ≥2 times ULN [except patients with evidence of Gilbert's syndrome]), known active hepatic disease (eg, hepatitis), evidence of clinically significant chronic liver disease or other condition affecting the liver (eg, chronic hepatitis) that may suggest the potential for an increased susceptibility to hepatic toxicity with oral morphine exposure. Subjects with no previous history of liver function impairment may be enrolled prior to receipt of screening laboratory testing results.
- Has significantly impaired renal function or disease, as evidenced by an estimated glomerular filtration rate (ie, from creatinine levels using the Schwartz formula) calculated to be less than one-third of normal for the applicable age of this study population. Subjects with no previous history of kidney function impairment may be enrolled prior to receipt of screening laboratory testing results.
- Has a history of substance abuse or there is evidence of current substance abuse, in the investigator's opinion.
- Has received epidural or regional anesthesia within 12 hours prior to the first dose of study drug.
- Has participated in an interventional clinical study (investigational or marketed product) within 30 days before screening, or plans to participate in another clinical trial in the next 30 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Open-Label, Safety and Pharmacokinetic Study of Oral Morphine Sulfate Administration in Pediatric Subjects 2 Years Old Through 17 Years Old With Postoperative Pain
This is a multicenter, open-label study to evaluate the safety and PK of oral morphine sulfate in pediatric subjects with post-operative pain.
- Conditions
- Pain, Postoperative
- Being tested
- Morphine Sulfate
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morphine SulfateDrug
Morphine every 4 hours as needed for up to a maximum of 5 days
| Study group | Role | What they receive |
|---|---|---|
| Morphine Sulfate | Other | oral morphine sulfate tablets oral morphine sulfate oral solution Receives: Drug: Morphine Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Maximum Plasma Concentration [Cmax]
Eight PK samples will be collected within the first 24 hours after the first dose
Measured: 24 hours
Measurement of Area Under the Curve [AUC]
Eight PK samples will be collected within the first 24 hours after the first dose
Measured: 24 hours
Number of Subjects who experience any AEs that lead to study discontinuation
Measured: 6 days
Number of subjects who experience serious adverse events
Measured: 6 days
Number of subjects with a UMSS sedation score of 4
Measured: 6 days
Secondary outcomes (3)
Number of subjects who experience any AEs of special interest
AEs of special interest include but not limited to sedation, respiratory depression, nausea, vomiting, and pruritus of moderate-to-severe intensity/grade
Measured: 6 days
Percentage of subjects with clinically significant decreases in SpO2
Measured: 6 days
Number of subject who experience significant change in respiratory rate
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start17 Apr 2018
- Primary completion29 May 2019
- Study completion29 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- West-Ward Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Responsible party
- Sponsor
- Investigators
- Susanne Schmidt, MD,PhD, Study director, Premier Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03429400
- Sponsor's protocol ID
- MORP-OS+T-(2-17)-SPK-2
- Status last verified
- Sep 2019
- First submitted
- 18 Jan 2018
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Safety and Pharmacokinetic Study of Oral Morphine Sulfate Administration in Pediatric Subjects 2 Years Old Through 17 Years Old With Postoperative Pain
- ClinicalTrials.gov ID
- NCT03429400
- Acronym / sponsor ID
- MORP-OS+T-(2-17)-SPK-2
- Conditions
- Pain, Postoperative
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- West-Ward PharmaceuticalIndustry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Study start
- 17 Apr 2018 (actual)
- Primary completion
- 29 May 2019 (actual)
- Study completion
- 29 May 2019 (actual)
- First posted
- 12 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, open-label study to evaluate the safety and PK of oral morphine sulfate in pediatric subjects with post-operative pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Morphine Sulfate | Other | Drug: Morphine Sulfateoral morphine sulfate tablets oral morphine sulfate oral solution |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (15 listed)
- Has a parent or guardian providing written parental permission/informed consent, with subject assent (if required by local IRB).
- Has an age-appropriate pain score of ≥4 prior to receiving first dose of study drug.
- Is a child 2 years old through 17 years old, inclusive (at the time of informed consent signing).
- Weighs at least 10 kg.
- Has a routine pediatric procedure that is expected to require inpatient hospitalization postoperatively.
Key exclusion criteria (11 listed)
- Has significant medical disease(s), laboratory abnormalities, or conditions(s) that in the investigator's judgment could compromise the subject's welfare, ability to communicate with study staff, complete study activities, or would otherwise contraindicate study participation. There is no minimum value for SpO2 for inclusion in the study; this should be based on the investigator's judgment.
- Has used opioids chronically (eg, codeine, morphine, oxycodone, or hydromorphone), for >7 calendar days within the previous 30 days prior to surgery.
- Has received codeine, hydrocodone, morphine or oxycodone in any form in the previous 7 calendar days prior to surgery.
- Is undergoing procedure for treatment of acute burns.
- Has known hypersensitivity or contraindication to receiving oral opioid(s).
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 |
|---|---|---|
| Morphine SulfateMorphine every 4 hours as needed for up to a maximum of 5 days | Drug | Morphine Sulfate |
Primary outcome
Measurement of Maximum Plasma Concentration [Cmax]
Time frame: 24 hours
Eight PK samples will be collected within the first 24 hours after the first dose
Measurement of Area Under the Curve [AUC]
Time frame: 24 hours
Eight PK samples will be collected within the first 24 hours after the first dose
Number of Subjects who experience any AEs that lead to study discontinuation
Time frame: 6 days
Number of subjects who experience serious adverse events
Time frame: 6 days
Number of subjects with a UMSS sedation score of 4
Time frame: 6 days
3 secondary outcomes
Number of subjects who experience any AEs of special interest
Time frame: 6 days
Percentage of subjects with clinically significant decreases in SpO2
Time frame: 6 days
Number of subject who experience significant change in respiratory rate
Time frame: 6 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
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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.
Susanne Schmidt, MD,PhD study director
Premier Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Morphine Sulfate in people with Pain, Postoperative, run by West-Ward Pharmaceutical at 1 site 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 15 inclusion and 11 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 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Measurement of Maximum Plasma Concentration [Cmax] (time frame: 24 hours). The study lists 5 primary outcomes in all. 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 26 Sep 2019.