PainPhase 3NCT01676493
A Study of Oral Codeine Sulfate in Pediatric Patients With Post-procedural Pain
A Phase 3 study testing Codeine in people with Pain, run by Roxane Laboratories at 1 site in United States.
Trial summary
This is a multicenter, open-label study to evaluate the safety and PK of oral codeine sulfate in pediatric subjects with mild to moderate post-procedural pain. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Pain
- What is being tested?
- Codeine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Aug 2012
- 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).
- Is a child 2 years old through 17 years old, inclusive (at the time of informed consent signing).
- Has a routine pediatric procedure that is expected to cause at least mild to moderate pain.
- Is expected by the investigator to require a minimum of one (1) dose of oral codeine for the treatment of mild to moderate post-procedural 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).
- If female subject is of childbearing potential, she must have a negative urine or serum pregnancy test result on the day of the scheduled procedure prior to the procedure. In this population, female of childbearing potential is defined by the onset of menarche, that is, menstruation, whether at irregular or regular intervals (periods).
- Must have vascular access to facilitate multiple blood draws.
Who cannot join
- Is currently lactating.
- 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.
- Weighs less than 10.5 kg. (see Table 4 Maximum Number of Doses of Study Drug by Weight for details)
- Has weight ≤ 5th or ≥ 95th percentile for age based on CDC Growth Charts. (see Appendix 6)
- Has received codeine, hydrocodone, morphine or oxycodone in any form in the previous seven (7) days.
- Has used opioids chronically (e.g., codeine, morphine, oxycodone, hydrocodone, or hydromorphone) for >7 calendar days within the previous 30 days before surgery.
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- Has known hypersensitivity or contraindication to receiving oral opioid(s).
- Has an 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 conditions affecting the liver (e.g., chronic hepatitis) that may suggest the potential for an increased susceptibility to hepatic toxicity with oral codeine exposure. NOTE: Subjects with no previous history of liver function impairment may be enrolled before results are available from screening laboratory samples.
- 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 (1/3) of normal for the applicable age of this study population. NOTE: Subjects with no previous history of kidney function impairment may be enrolled before results are available from screening laboratory samples.
- Is undergoing a procedure as treatment for acute burns.
- Has a history of substance abuse or there is evidence of current substance abuse, in the investigator's opinion.
- 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.
United States1 site
Children's Medical Center Dallas
Dallas, Texas, 75235
About this study
Official title: A Multicenter, Open-Label, Safety and Pharmacokinetic Study of Oral Codeine Sulfate Administration in Pediatric Subjects 2 Years Old Through 17 Years Old With Post-procedural Pain
This is a multicenter, open-label study to evaluate the safety and PK of oral codeine sulfate in pediatric subjects with mild to moderate post-procedural pain.
Read the detailed description
Eligible pediatric subjects will complete all screening procedures within 14 days before the scheduled procedure. Screening will be permitted on the day of the procedure. At screening, the subject's parent or guardian will provide written parental permission/informed consent to participate in the study and subjects will provide assent (if required by the local Institutional Review Board [IRB]) before any protocol-specified procedures or assessments are performed.
Subjects may be inpatients, outpatients, or day-surgery patients at the study site who will undergo procedures expected to result in at least mild to moderate post-procedure pain with the day of the procedure noted as Day 0, and will be followed until discharge from the study site.
- Conditions
- Pain
- Being tested
- Codeine
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CodeineDrug
Also called Codeine Sulfate Oral Solution and Tablets
| Study group | Role | What they receive |
|---|---|---|
| Codeine | Experimental | Codeine Sulfate Oral Solution and Tablet Receives: Drug: Codeine |
What is being measured
The primary outcome is the main question the study is designed to answer.
tolerability and safety
- Percentage of subjects who experience any AEs with a causal relationship to the study medication characterized as possible, probable or unknown (unable to judge).
- Percentage of subjects with SAEs.
- Percentage of subjects with a UMSS sedation score of 4.
Measured: up to 24 hours
analyte concentrations from blood samples
Initial Dose of Study Drug
- Immediately (up to 30 minutes) prior to the dose of oral codeine sulfate.
- 1 hour (45 to 75 minutes) after administration of the initial dose of oral codeine sulfate.
- 2 hours (105 to 135 minutes) after administration of the initial dose of oral codeine sulfate.
Subsequent Doses
- Immediately (up to 30 minutes) prior to the dose of oral codeine sulfate.
- 1 hour (45 to 75 minutes) after administration of the dose of oral codeine sulfate.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2012 (estimated)
- Study startApr 2012
- Primary completionAug 2012
- Study completionAug 2012
Why it stopped: Decision to stop study due to low recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roxane Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Responsible party
- Sponsor
- Investigators
- Dante Landucci, MD, Principal investigator, Quintiles, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01676493
- Sponsor's protocol ID
- CODE-OS+T-(2-17)-SPK-1
- Status last verified
- Oct 2018
- First submitted
- 24 Aug 2012
- Last updated
- 2 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 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 Codeine Sulfate Administration in Pediatric Subjects 2 Years Old Through 17 Years Old With Post-procedural Pain
- ClinicalTrials.gov ID
- NCT01676493
- Acronym / sponsor ID
- CODE-OS+T-(2-17)-SPK-1
- Conditions
- Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Decision to stop study due to low recruitment.
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Roxane LaboratoriesIndustry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Study start
- Apr 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 31 Aug 2012 (estimated)
- 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 codeine sulfate in pediatric subjects with mild to moderate post-procedural pain.
Detailed description
Eligible pediatric subjects will complete all screening procedures within 14 days before the scheduled procedure. Screening will be permitted on the day of the procedure. At screening, the subject's parent or guardian will provide written parental permission/informed consent to participate in the study and subjects will provide assent (if required by the local Institutional Review Board [IRB]) before any protocol-specified procedures or assessments are performed.
Subjects may be inpatients, outpatients, or day-surgery patients at the study site who will undergo procedures expected to result in at least mild to moderate post-procedure pain with the day of the procedure noted as Day 0, and will be followed until discharge from the study site.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Codeine | Experimental | Drug: CodeineCodeine Sulfate Oral Solution and Tablet |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Has a parent or guardian providing written parental permission/informed consent, with subject assent (if required by local IRB).
- Is a child 2 years old through 17 years old, inclusive (at the time of informed consent signing).
- Has a routine pediatric procedure that is expected to cause at least mild to moderate pain.
- Is expected by the investigator to require a minimum of one (1) dose of oral codeine for the treatment of mild to moderate post-procedural 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).
Key exclusion criteria (13 listed)
- Is currently lactating.
- 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.
- Weighs less than 10.5 kg. (see Table 4 Maximum Number of Doses of Study Drug by Weight for details)
- Has weight ≤ 5th or ≥ 95th percentile for age based on CDC Growth Charts. (see Appendix 6)
- Has received codeine, hydrocodone, morphine or oxycodone in any form in the previous seven (7) days.
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 |
|---|---|---|
| CodeineAlso: Codeine Sulfate Oral Solution and Tablets | Drug | Codeine |
Primary outcome
tolerability and safety
Time frame: up to 24 hours
* Percentage of subjects who experience any AEs with a causal relationship to the study medication characterized as possible, probable or unknown (unable to judge). * Percentage of subjects with SAEs. * Percentage of subjects with a UMSS sedation score of 4.
analyte concentrations from blood samples
Time frame: 24 hours
Initial Dose of Study Drug * Immediately (up to 30 minutes) prior to the dose of oral codeine sulfate. * 1 hour (45 to 75 minutes) after administration of the initial dose of oral codeine sulfate. * 2 hours (105 to 135 minutes) after administration of the initial dose of oral codeine sulfate. Subsequent Doses * Immediately (up to 30 minutes) prior to the dose of oral codeine sulfate. * 1 hour (45 to 75 minutes) after administration of the dose of oral codeine sulfate.
Results and safety
The study was stopped early (reason given: Decision to stop study due to low recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2018.
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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, MD principal investigator
Quintiles, Inc.
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 Codeine in people with Pain, run by Roxane Laboratories 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 7 inclusion and 13 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: stopped early, as of the sponsor's last update on 2 Oct 2018. 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 was stopped early (reason given: Decision to stop study due to low recruitment.). Results are not available in the source record.
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?
tolerability and safety (time frame: up to 24 hours). The study lists 2 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 2 Oct 2018.