Chronic PainPhase 1NCT03398278
OTR Tablet 40 mg Fasted-state Bioequivalence Study
A Phase 1 study testing Oxycodone Tamper Resistant and OXYCONTIN® in people with Chronic Pain, run by Mundipharma (China) Pharmaceutical Co. Ltd at 1 site in China.
Trial summary
This is an open-label, single dose, randomised, cross-over study to confirm the bioequivalence (BE) of OTR tablet 40 mg and OXYCONTIN tablet 40 mg in a fasted state in Chinese subjects with chronic pain Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Oxycodone Tamper Resistant and OXYCONTIN®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2017to 20 Mar 2018
- Phase
- Phase 1
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Chinese male or female subjects with histories of chronic pain regardless of the aetiology, aged 18-55 years both inclusive
- The average pain over the last 24 hours should be scored < 4 assessed with Numeric Rating Scales (NRS), when not receiving analgesics. The pain condition has been kept stable at least in the past 7 days prior to entering into the screening and is expected to be stable during the study duration
- Body weight ≥45 kg and a body mass index (BMI) ≥18 and ≤28 kg/m2
- Karnofsky score of Performance Status ≥70
- Willing to take all the food supplied while the subject is in the study unit
- Be able to read, understand, and sign written Informed Consent Form (ICF) prior to study participation and be willing to follow the protocol requirements
- Willing to use adequate and highly effective methods of contraception throughout the study. A highly effective method of birth control is defined as one which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as sterilisation, implants, injectables, some Intrauterine Device (IUD), sexual abstinence, or vasectomised partner
- Female subjects, including those up to less than one year post-menopausal, must have a negative serum pregnancy test and be non-lactating
Who cannot join
- Subjects who are currently taking opioids or have used opioids in the past 14 days prior to receiving the study drug
- Have hypersensitivity history to any opioids, naltrexone, naloxone, or related compounds or any contraindications as detailed in the OTR and OXYCONTIN tablet Summary of Product Characteristics
- Histories of or any current conditions that might interfere with drug absorption, distribution, metabolism, or excretion
- Subjects who are likely to have paralytic ileus or acute abdomen or to require an operation on abdominal regions
- Subjects with biliary tract diseases, pancreatitis, prostatic hypertrophy, or corticoadrenal insufficiency
- Subjects with respiratory depression, corpulmonale, or chronic bronchial asthma
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- Any history of seizures or symptomatic head trauma
- Subjects with abnormal liver function (values exceeding the upper limit of normal (ULN) for alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin during the Screening Phase) or abnormal renal function (values exceeding the ULN for serum creatinine during the Screening Phase). Note: if the values of ALT, AST or total bilirubin are between 1 to 1.2 times of ULN and confirmed not clinically significant by the Investigators, the subject may be recruited after getting the approval from Sponsor.
- Any other significant illness other than the primary disease of chronic pain during the 4 weeks preceding the entry into this study
- Subjects who are unable to stop taking monoamine oxidase inhibitors during this trial period or time lapses less than 2 weeks since drug withdrawal prior to the study drug administration
- Subjects who are currently taking tricyclic antidepressants or have used tricyclic antidepressants within 4 weeks prior to the study drug administration
- Subjects who have used any medicinal product which inhibits Cytochrome P450 3A4 (CYP3A4) (e.g. troleandomycin, ketoconazole, gestodene, etc.) or induces CYP3A4 (e.g. glucocorticoids, barbiturates, rifampicin, etc.) within 4 weeks prior to the study drug administration
- Subjects who have used any medicinal product which inhibits Cytochrome P450 2D6 (CYP2D6) (e.g. fluoxetine, quinidine, ritonavir, etc.) or induces CYP2D6 (e.g. dexamethasone, rifampicin, glutethimide, etc.) within 4 weeks prior to the study drug administration
- Histories of smoking (being a smoker or an occasional smoker) within 45 days prior to the study drug administration and refusal to abstain from smoking during the study. According to World Health Organization (WHO), a smoker is defined as having smoked at least 1 cigarette per day continuously for more than 6 months and an occasional smoker is defined as having smoked for more than 4 times per week and less than 1 cigarette per day continuously for more than 6 months.
- Subjects with histories of alcoholism or drug abuse. Alcoholism is defined as regular alcohol consumption exceeding 14 drinks/week (1 drink = 150 mL of wine or 360 mL of beer or 45 mL of hard liquor)
- Consumption of alcoholic beverages within 48 hours before study drug administration, and refusal to abstain from alcohol for at least 48 hours after study drug administration
- Refusal to abstain from food for 10 hours preceding and 4 hours following administration of the study drug and to abstain from caffeine or xanthine entirely during each confinement
- Positive Hepatitis B Surface Antigen (HBsAg), anti-Hepatitis C Virus (HCV), anti-Human Immunodeficiency Virus (HIV), or syphilis antibody test result
- Urine screening before study is positive for opioids, barbiturates, amphetamines, cocaine metabolites, methadone, benzodiazepines, phencyclidine, methamphetamine, or cannabinoids. Or alcohol breath test is positive
- Any history of frequent nausea or emesis regardless of aetiology
- Blood or blood products donated within 30 days prior to administration of the study drugs or anytime during the study, except as required by this protocol
- Subjects who participated in a clinical research study within 30 days of study entry
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Single Dose, Randomised, Cross-over Study to Determine the Fasted State Pharmacokinetics of Oxycodone From Oxycodone Tamper Resistant (OTR) Tablet 40 mg and OXYCONTIN® Tablet 40 mg in Chinese Subjects With Chronic Pain
This is an open-label, single dose, randomised, cross-over study to confirm the bioequivalence (BE) of OTR tablet 40 mg and OXYCONTIN tablet 40 mg in a fasted state in Chinese subjects with chronic pain
Read the detailed description
In this BE study, subjects with histories of chronic pain are chosen as the target population.
Inclusion/exclusion criteria are strictly defined to reduce the potential variation of the PK data.
Single dose design is chosen per Food and Drug Administration (FDA)/WHO guideline on bioavailability (BA)/BE studies for modified-release products.
As a general rule, cross-over design is applied in the study to decrease the inter-individual variations between the two cohorts. A washout period lasting for at least 7 half-lives of the investigational medicine is needed to eliminate the drug residual from the previous period7. The elimination half-life of oxycodone from OTR is 4.5 hours, and a 6-day washout period is sufficient to achieve the aim.
- Conditions
- Chronic Pain
- Being tested
- Oxycodone Tamper Resistant, OXYCONTIN®
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxycodone Tamper ResistantDrug
Also called Oxycodone Tamper Resistant (OTR) Tablet 40 mg
Orally taking Oxycodone Tamper Resistant 40mg in fast state
OXYCONTIN®Drug
Also called OXYCONTIN® Tablet 40 mg
Orally taking OXYCONTIN® 40mg in fast state
| Study group | Role | What they receive |
|---|---|---|
| Oxycodone Tamper Resistant | Experimental | Oxycodone Tamper Resistant (OTR) Tablet 40 mg Receives: Drug: Oxycodone Tamper Resistant |
| OXYCONTIN® | Active comparator | OXYCONTIN® Tablet 40 mg Receives: Drug: OXYCONTIN® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fasted State
The analysis was for PK parameters Cmax of analyte oxycodone. Analysis of Variance (ANOVA) with fixed effect terms for treatment, period, sequence, and subject within sequence for ratio of means (using log scale) were used to compare the test and the reference treatments.
Measured: up to 32 hours
AUCt of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fasted State
The analysis was for PK parameters AUCt of analyte oxycodone. Analysis of Variance (ANOVA) with fixed effect terms for treatment, period, sequence, and subject within sequence for ratio of means (using log scale) were used to compare the test and the reference treatments.
Measured: up to 32 hours
AUCINF of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fasted State
The analysis was for PK parameters AUCINF for analyte oxycodone. Analysis of Variance (ANOVA) with fixed effect terms for treatment, period, sequence, and subject within sequence for ratio of means (using log scale) was used to compare the test and the reference treatments.
Measured: up to 32 hours
Secondary outcomes (5)
Adverse Event of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg, When Given to Chinese Subjects With Chronic Pain in a Fasted State
An overall summary of adverse events will be provided by treatment groups. The number and percentage of subjects reporting adverse events will be summarised by the preferred term nested within the System Organ Classification. In addition the number of reported adverse events will be summarised.
Measured: up to 35 days
Number of Lab Tests With Clinical Significance
Clinical laboratory data to be summarised includes haematology, blood chemistry, and urinalysis.Each parameter will be assigned an LNH classification according to whether the value is lower than (L), within (N) or higher than (H) the reference range for that parameter. Results will be summarised using shift tables to evaluate categorical changes from baseline to end of study with respect to reference range values (lower than, within, and higher than).
Measured: up to 35 days
Number of AEs Related to Vital Sign
Vital sign parameters to be summarised include systolic blood pressure, diastolic blood pressure, pulse rate, respiration rate, and axillary temperature. Vital sign results for each parameter will be assigned an LNH classification according to whether the value is lower than (L), within (N), or higher than (H) the reference range for that parameter. Vital sign results will be summarised using shift tables to evaluate categorical changes from baseline to end of study with respect to reference range values (lower than, within, and higher than).
Measured: up to 35 days
Number of AEs Related to ECGs
Twelve-lead ECG was conducted at screening and on Day 4 of Period 2.
Measured: up to 35 days
Number of AEs Related to Physical Examination
Physical examination was conducted at screening, and on Day -1, Day 4 in each Period.
Measured: up to 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start30 Jun 2017
- Primary completion15 Oct 2017
- Study completion20 Mar 2018
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 Chronic 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mundipharma (China) Pharmaceutical Co. Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ZHU LUO, PhD, Principal investigator, West Hospital, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03398278
- Sponsor's protocol ID
- ONF16-CN-102
- Status last verified
- Jan 2020
- First submitted
- 26 Jul 2016
- Last updated
- 31 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not this kind of plan with the study
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single Dose, Randomised, Cross-over Study to Determine the Fasted State Pharmacokinetics of Oxycodone From Oxycodone Tamper Resistant (OTR) Tablet 40 mg and OXYCONTIN® Tablet 40 mg in Chinese Subjects With Chronic Pain
- ClinicalTrials.gov ID
- NCT03398278
- Acronym / sponsor ID
- ONF16-CN-102
- Conditions
- Chronic Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Mundipharma (China) Pharmaceutical Co. LtdIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2017 (actual)
- Primary completion
- 15 Oct 2017 (actual)
- Study completion
- 20 Mar 2018 (actual)
- First posted
- 12 Jan 2018 (actual)
- Results
- Posted 31 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, single dose, randomised, cross-over study to confirm the bioequivalence (BE) of OTR tablet 40 mg and OXYCONTIN tablet 40 mg in a fasted state in Chinese subjects with chronic pain
Detailed description
In this BE study, subjects with histories of chronic pain are chosen as the target population.
Inclusion/exclusion criteria are strictly defined to reduce the potential variation of the PK data.
Single dose design is chosen per Food and Drug Administration (FDA)/WHO guideline on bioavailability (BA)/BE studies for modified-release products.
As a general rule, cross-over design is applied in the study to decrease the inter-individual variations between the two cohorts. A washout period lasting for at least 7 half-lives of the investigational medicine is needed to eliminate the drug residual from the previous period7. The elimination half-life of oxycodone from OTR is 4.5 hours, and a 6-day washout period is sufficient to achieve the aim.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxycodone Tamper Resistant | Experimental | Drug: Oxycodone Tamper ResistantOxycodone Tamper Resistant (OTR) Tablet 40 mg |
| OXYCONTIN® | Active comparator | Drug: OXYCONTIN®OXYCONTIN® Tablet 40 mg |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Chinese male or female subjects with histories of chronic pain regardless of the aetiology, aged 18-55 years both inclusive
- The average pain over the last 24 hours should be scored < 4 assessed with Numeric Rating Scales (NRS), when not receiving analgesics. The pain condition has been kept stable at least in the past 7 days prior to entering into the screening and is expected to be stable during the study duration
- Body weight ≥45 kg and a body mass index (BMI) ≥18 and ≤28 kg/m2
- Karnofsky score of Performance Status ≥70
- Willing to take all the food supplied while the subject is in the study unit
Key exclusion criteria (22 listed)
- Subjects who are currently taking opioids or have used opioids in the past 14 days prior to receiving the study drug
- Have hypersensitivity history to any opioids, naltrexone, naloxone, or related compounds or any contraindications as detailed in the OTR and OXYCONTIN tablet Summary of Product Characteristics
- Histories of or any current conditions that might interfere with drug absorption, distribution, metabolism, or excretion
- Subjects who are likely to have paralytic ileus or acute abdomen or to require an operation on abdominal regions
- Subjects with biliary tract diseases, pancreatitis, prostatic hypertrophy, or corticoadrenal insufficiency
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 |
|---|---|---|
| Oxycodone Tamper ResistantAlso: Oxycodone Tamper Resistant (OTR) Tablet 40 mgOrally taking Oxycodone Tamper Resistant 40mg in fast state | Drug | Oxycodone Tamper Resistant |
| OXYCONTIN®Also: OXYCONTIN® Tablet 40 mgOrally taking OXYCONTIN® 40mg in fast state | Drug | OXYCONTIN® |
Primary outcome
Cmax of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fasted State
Time frame: up to 32 hours
The analysis was for PK parameters Cmax of analyte oxycodone. Analysis of Variance (ANOVA) with fixed effect terms for treatment, period, sequence, and subject within sequence for ratio of means (using log scale) were used to compare the test and the reference treatments.
AUCt of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fasted State
Time frame: up to 32 hours
The analysis was for PK parameters AUCt of analyte oxycodone. Analysis of Variance (ANOVA) with fixed effect terms for treatment, period, sequence, and subject within sequence for ratio of means (using log scale) were used to compare the test and the reference treatments.
AUCINF of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fasted State
Time frame: up to 32 hours
The analysis was for PK parameters AUCINF for analyte oxycodone. Analysis of Variance (ANOVA) with fixed effect terms for treatment, period, sequence, and subject within sequence for ratio of means (using log scale) was used to compare the test and the reference treatments.
5 secondary outcomes
Adverse Event of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg, When Given to Chinese Subjects With Chronic Pain in a Fasted State
Time frame: up to 35 days
Number of Lab Tests With Clinical Significance
Time frame: up to 35 days
Number of AEs Related to Vital Sign
Time frame: up to 35 days
Number of AEs Related to ECGs
Time frame: up to 35 days
Number of AEs Related to Physical Examination
Time frame: up to 35 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Not this kind of plan with the study
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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.
ZHU LUO, PhD principal investigator
West Hospital, Sichuan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oxycodone Tamper Resistant and OXYCONTIN® in people with Chronic Pain, run by Mundipharma (China) Pharmaceutical Co. Ltd at 1 site in China.
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 8 inclusion and 22 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 31 Jan 2020. 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 China. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 31 Oct 2019). 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?
Cmax of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fasted State (time frame: up to 32 hours). The study lists 3 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 31 Jan 2020.