PainPhase 4NCT01322360
Safety and Pharmacokinetic Study of Oral Morphine Sulfate in Pediatric Subjects
A Phase 4 study testing Morphine Sulfate in people with Pain, run by Roxane Laboratories at 11 sites in United States.
Trial summary
The purpose of this study is to evaluate the tolerability and safety of oral morphine sulfate in the treatment of postoperative pain in different pediatric age groups following multiple-dose administration. To determine multiple-dose pharmacokinetics (PK) of morphine sulfate in pediatric subjects. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Pain
- 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
- 50 participants
- Where
- 11 sitesUnited States
- Study dates
- Apr 2011to Apr 2012
- 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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- parent or guardian provided written parental permission/informed consent, with subject assent (if required by local IRB).
- The child is 2 years old through 17 years old, inclusive (at the time of informed consent signing).
- A routine pediatric procedure is expected to require inpatient hospitalization postoperatively.
- Must be an inpatient for the study treatment period.
- Is expected by the investigator to require use of oral opioid for the treatment of postoperative pain.
- 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).
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- Child is expected to experience moderate to severe postoperative pain, in the investigator's opinion, during the immediate postoperative period after discontinuation of intermittent administration of IV opioid (preferably morphine) and is able to tolerate oral medications.
- If female subject is of childbearing potential, she must have a negative pregnancy test result at screening (serum) and on the day of surgery prior to surgery (urine).
- 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 (e.g., codeine, morphine, oxycodone, or hydromorphone, for >7 calendar days) within the previous 30 days.
- Has known hypersensitivity or contraindication to receiving oral opioid(s).
- Has a current active enteral malabsorption disorder.
- Has impaired liver function (e.g., alanine aminotransferase [ALT] ≥3 times the upper limit of normal [ULN], or bilirubin ≥3 times ULN), known active hepatic disease (e.g., hepatitis), evidence of clinically significant chronic liver disease or other condition affecting the liver (e.g., 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 (i.e., 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.
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- 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 oral morphine sulfate.
- 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
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Children's Hospital Medical Center of Akron d/b/a Akron Children's Hospital
Akron, Ohio, 44302
University of Texas Southwestern Medical Center
Dallas, Texas, 75235
Children's Hospital of Michigan
Detroit, Michigan, 48201
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
University of Texas Health Science Center of Houston
Houston, Texas, 77030
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232
Yale New Haven Children's Hospital
New Haven, Connecticut, 06510
Maricopa Integrated Health System
Phoenix, Arizona, 85008
Stanford University Medical Center
Stanford, California, 94305
Children's National Medical Center
Washington D.C., District of Columbia, 20010
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
The purpose of this study is to evaluate the tolerability and safety of oral morphine sulfate in the treatment of postoperative pain in different pediatric age groups following multiple-dose administration.
To determine multiple-dose pharmacokinetics (PK) of morphine sulfate in pediatric subjects.
To compare plasma concentration of morphine sulfate in each age group of pediatric subjects with adult plasma morphine sulfate concentrations.
- Conditions
- Pain
- Being tested
- Morphine Sulfate
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morphine SulfateDrug
Also called Morphine Sulfate Oral Solution, Morphine Sulfate Tablet
| Study group | Role | What they receive |
|---|---|---|
| Morphine Sulfate | Other | oral solution (10 mg/5 mL or 20 mg/5 mL) or tablets (15 mg or 30 mg)given based on based on the current pediatric prescribing guidelines Receives: Drug: Morphine Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Who Experienced Adverse Events That Led to Study Discontinuation
The primary safety endpoints were the percentage of subjects who experienced any AEs that led to study discontinuation, percentage of subjects with SAEs and those with a sedation score of 4. Secondary safety endpoints included the percentage of subjects who experienced any AEs of special interest, which included sedation, respiratory depression, nausea, vomiting, and pruritus of moderate to severe intensity/grade.
Additional secondary endpoints were the incidence, type, relationship to study drug, and severity of AEs, and the percentage of subjects with clinically significant decreases in SpO2 and respiratory rate, as assessed by the investigator.
Measured: Up to 21 days
Secondary outcomes (1)
Number of Subjects Who Experienced Adverse Events of Moderate to Severe Intensity / Grade
Subjects who experienced any AEs of special interest, which included sedation, respiratory depression, nausea, vomiting, and pruritus of moderate to severe intensity/grade
Measured: Up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2012
- Study completionApr 2012
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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roxane Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dante Landucci, M.D., Study director, Quintiles, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01322360
- Sponsor's protocol ID
- MORP-OS+T-(2-17)-SPK-1
- Status last verified
- Jan 2018
- First submitted
- 21 Mar 2011
- Last updated
- 5 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. 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
- NCT01322360
- Acronym / sponsor ID
- MORP-OS+T-(2-17)-SPK-1
- Conditions
- Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Roxane LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 24 Mar 2011 (estimated)
- Results
- Posted 23 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the tolerability and safety of oral morphine sulfate in the treatment of postoperative pain in different pediatric age groups following multiple-dose administration.
To determine multiple-dose pharmacokinetics (PK) of morphine sulfate in pediatric subjects.
To compare plasma concentration of morphine sulfate in each age group of pediatric subjects with adult plasma morphine sulfate concentrations.
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 solution (10 mg/5 mL or 20 mg/5 mL) or tablets (15 mg or 30 mg)given based on based on the current pediatric prescribing guidelines |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- parent or guardian provided written parental permission/informed consent, with subject assent (if required by local IRB).
- The child is 2 years old through 17 years old, inclusive (at the time of informed consent signing).
- A routine pediatric procedure is expected to require inpatient hospitalization postoperatively.
- Must be an inpatient for the study treatment period.
- Is expected by the investigator to require use of oral opioid for the treatment of postoperative pain.
Key exclusion criteria (9 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 (e.g., codeine, morphine, oxycodone, or hydromorphone, for >7 calendar days) within the previous 30 days.
- Has known hypersensitivity or contraindication to receiving oral opioid(s).
- Has a current active enteral malabsorption disorder.
- Has impaired liver function (e.g., alanine aminotransferase [ALT] ≥3 times the upper limit of normal [ULN], or bilirubin ≥3 times ULN), known active hepatic disease (e.g., hepatitis), evidence of clinically significant chronic liver disease or other condition affecting the liver (e.g., 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.
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 SulfateAlso: Morphine Sulfate Oral Solution, Morphine Sulfate Tablet | Drug | Morphine Sulfate |
Primary outcome
Number of Subjects Who Experienced Adverse Events That Led to Study Discontinuation
Time frame: Up to 21 days
The primary safety endpoints were the percentage of subjects who experienced any AEs that led to study discontinuation, percentage of subjects with SAEs and those with a sedation score of 4. Secondary safety endpoints included the percentage of subjects who experienced any AEs of special interest, which included sedation, respiratory depression, nausea, vomiting, and pruritus of moderate to severe intensity/grade. Additional secondary endpoints were the incidence, type, relationship to study drug, and severity of AEs, and the percentage of subjects with clinically significant decreases in SpO2 and respiratory rate, as assessed by the investigator.
1 secondary outcome
Number of Subjects Who Experienced Adverse Events of Moderate to Severe Intensity / Grade
Time frame: Up to 21 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
- 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.
Dante Landucci, M.D. study director
Quintiles, Inc.
11 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 Morphine Sulfate in people with Pain, run by Roxane Laboratories at 11 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 9 inclusion and 9 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 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 23 May 2014). 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?
Number of Subjects Who Experienced Adverse Events That Led to Study Discontinuation (time frame: Up to 21 days). 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 5 Feb 2018.