Chronic PainPhase 1NCT03975010
Buprenorphine Transdermal Patches Pharmacokinetic Study
A Phase 1 study testing Buprenorphine Transdermal Patch in people with Chronic Pain, run by Mundipharma (China) Pharmaceutical Co. Ltd at 1 site in China.
Trial summary
This is an open-label, randomised, single-dose, 3 arms study design. 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?
- Buprenorphine Transdermal Patch
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 13 May 2019to 31 Mar 2020
- Phase
- Phase 1
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Chinese male or female subjects with chronic pain (regardless of the aetiology, cancer-pain excluded), aged 18-55 years (both inclusive).
- The average pain over the last 24 hours should attain ≤ 3 assessed with Numeric Rating Scales (NRS) refer to section 19.5. The pain condition has been lasting for at least 1 month and stable for 7 days prior to entering into the screening and is expected to be stable during the study duration.
- Patients on stable permissible non-opioid analgesics, who in the opinion of the investigator are unlikely to require a change in treatment during the study.
- Karnofsky score of Performance Status ≥ 70.
- Body mass index (BMI) of 19 to 28 kg/m2 (both inclusive); and a total body weight ≥ 50 kg.
- Normal dietary habits (e.g. not vegetarian nor vegan) and willing to only take the food supplied during the period of hospitalization.
- Subjects who are able to read, understand and sign written informed consent prior to study participation and are willing to follow the protocol requirements.
- Female subjects of child bearing potential (less than 1 year post-menopausal) must have a negative urine pregnancy test prior to first dose of study medication, be non-lactating, and willing to use adequate and highly effective methods of birth control throughout the study such as sterilisation, implants, injectables, combined oral contraceptives, some intra-uterine devices, sexual abstinence or vasectomised partner. Male subjects (surgical history of bilateral vasectomy excluded) with a partner of child bearing potential must be willing to use adequate and highly effective methods of birth control throughout the study.
Who cannot join
- Unstable condition of the primary disease of chronic pain, which, in the opinion of the investigator, would complicate the subject's participation in the study (e.g. require initiation of new medication).
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies).
- History of seizures or at risk (i.e. head trauma, epilepsy in family, anamnesis, unclear loss of consciousness).
- Any history of frequent nausea or emesis regardless of aetiology.
- Malignancy or a history of malignancy.
- History of orthostatic hypotension.
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- Subjects who have any medical or surgical conditions that might interfere with transdermal absorption, distribution, metabolism, or excretion of drugs.
- Positive results for Hepatitis B surface antigen (HBsAg), Hepatitis C virus antibodies (HCV Ab), human immunodeficiency virus antibodies (HIVAb).
- Urine screening before study is positive for opioids, barbiturates, amphetamines, cocaine metabolites, methadone, benzodiazepines, phencyclidine, methamphetamine, or cannabinoids or alcohol breath test is positive.
- Subjects who have a current or past (within 5 years) history of substance or alcohol abuse, or subjects who, in the opinion of the investigator or the sub-investigator, have demonstrated addictive or substance abuse behaviors. Alcohol abuse 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 patch application, and / or refusal to abstain from alcohol throughout the study until at least 48 hours after patch removal.
- Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
- Use of any medicinal product which inhibits CYP3A4 (e.g. troleandomycin, ketoconazole, gestodene, etc) or induces CYP3A4 (e.g. glucocorticoids, barbiturates, rifampicin,etc) within 4 weeks prior to first patch administration.
- Subjects who are currently taking tricyclic antidepressants or have used tricyclic antidepressants within 4 weeks prior to the first patch administration.
- Subjects taking monoamine oxidase (MAO) inhibiters within the past 14 days prior to the first patch administration
- Subjects taking any opioid drug within the past 14 days prior to the first patch administration.
- Use of prescription or nonprescription drugs, vitamins and dietary supplements within 7 days prior to the first patch administration. As an exception, acetaminophen could have been used at doses of ≤1 g/day.
- Subjects who participated in a clinical research study involving a new chemical entity or an experimental drug within 30 days prior to the screening visit. Concurrent enrolment in another clinical trial is not permitted unless the sole purpose of the other trial is for collection of long-term follow-up/survival data.
- Donated 400 mL or more of blood or blood products within 3 months prior to the start of the study.
- Screening sitting blood pressure (BP) ≥140 mm Hg (systolic) or ≥ 90 mm Hg (diastolic), following at least 5 minutes of rest. If BP is ≥140 mm Hg (systolic) or ≥ 90 mm Hg (diastolic), the BP should be repeated two more times and the average of the three BP values should be used to determine the subject's eligibility.
- 12-lead ECG demonstrating QTc>450 msec or a QRS interval >120 msec at Screening. If QTc exceeds 450 msec, or QRS interval exceeds 120 msec, the ECG should be repeated two more times and the average of the three QTc or QRS interval values should be used to determine the subject's eligibility.
- Subjects who have history of hypersensitivity to opioid analgesic formulations.
- Subjects who have history of hypersensitivity to naltrexone.
- Subjects who have history of hypersensitivity to transdermal delivery system or patch adhesives.
- Subjects with any potential dermatological disorder at a patch application site, e.g. previous and/or current unhealed extensive dermal damage in the area where the patch will be applied (e.g. dermatitis, burns, tattoos, scarring of the skin)
- Subjects who could not discontinue therapy that involved direct heat sources (e.g. heat lamps, electric blankets, heating pads or heated water beds) for the duration of the study
- Subjects with hairy areas who could not, or would not, cut the hair at the patch site for proper placement of the patch
- Special diets such as caffeine or xanthine-containing foods and beverages (including pitaya fruit, mango, grapefruit, coffee, tea, cola, chocolate, grapefruit juice, etc.) should be taken within 48 hours before patch application or during the study.
- Subjects who have difficulty swallowing tablets.
- Subjects who cannot tolerate venipuncture, or subjects who have difficulty in collecting blood, or subjects who have a history of fainting at the sight of blood or needles.
- Unwilling or suspected of not being able to comply with the study protocol.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Shenyang, Liaoning
Wenping Wang, Doctor, 86 24 31961971, wangwenping@hotmail.com
About this study
Official title: An Open-label, Randomized, Single-dose, Parallel-group Study to Investigate the PK Profile of Single Dose Buprenorphine Transdermal Patch 20 mg Applied for 3 Days, 40 mg for 3 Days and 40 mg for 4 Days in Chinese Subjects With Chronic Pain
This is an open-label, randomised, single-dose, 3 arms study design.
Read the detailed description
Subjects will be randomised into one of 3 arms, in a 1:1:1 ratio, wearing BUP TDS 20 mg for 3 days or 40 mg for 3 days or 40 mg for 4 days.
- Conditions
- Chronic Pain
- Being tested
- Buprenorphine Transdermal Patch
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buprenorphine Transdermal PatchDrug
Also called Naltrexone Hydrochloride
This is an open-label, randomised, single-dose, 3 arms study design. Subjects will be randomised into one of 3 arms, in a 1:1:1 ratio, wearing BUP TDS 20 mg for 3 days or 40 mg for 3 days or 40 mg for 4 days. Safety follow-up will be planned at 7~9 days after patch removal.
The study patch will be applied under the cover of naltrexone to reduce opioid related side-effects. Naltrexone 50 mg will be taken orally every 12 hours, from the evening of Day 00 (13 hours prior to IMP application), until the evening of the patch removal.
| Study group | Role | What they receive |
|---|---|---|
| BUP TDS 20 mg for 3 days | Experimental | Subjects will be randomized into the arms, use BUP TDS 20 mg for 3 days. Receives: Drug: Buprenorphine Transdermal Patch |
| BUP TDS 40 mg for 3 days | Experimental | Subjects will be randomized into the arms, use BUP TDS 40 mg for 3 days. Receives: Drug: Buprenorphine Transdermal Patch |
| BUP TDS 40 mg for 4 day | Experimental | Subjects will be randomized into the arms, use BUP TDS 40 mg for 4 days. Receives: Drug: Buprenorphine Transdermal Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the pharmacokinetic profile of buprenorphine and its primary metabolite, norbuprenorphine_Cmax
Pharmacokinetic parameters of the prototype buprenorphine, and the primetabolite norbuprenorphine, calculated from plasma concentration-time data following a single application of BUP TDS 20 mg (3 days), 40 mg (3 days) and 40 mg (4 days).
Measured: from Day0 to Day8 or Day9
To evaluate the pharmacokinetic profile of buprenorphine and its primary metabolite, norbuprenorphine_AUCt
Pharmacokinetic parameters of the prototype buprenorphine, and the primetabolite norbuprenorphine, calculated from plasma concentration-time data following a single application of BUP TDS 20 mg (3 days), 40 mg (3 days) and 40 mg (4 days).
Measured: from Day0 to Day8 or Day9
To evaluate the pharmacokinetic profile of buprenorphine and its primary metabolite, norbuprenorphine_AUCinf
Pharmacokinetic parameters of the prototype buprenorphine, and the primetabolite norbuprenorphine, calculated from plasma concentration-time data following a single application of BUP TDS 20 mg (3 days), 40 mg (3 days) and 40 mg (4 days).
Measured: from Day0 to Day8 or Day9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start13 May 2019
- Primary completion31 Mar 2020 (estimated)
- Study completion31 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mundipharma (China) Pharmaceutical Co. Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wenping Wang, PhD, Principal investigator, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03975010
- Sponsor's protocol ID
- BUP14-CN-101
- Status last verified
- Jun 2019
- First submitted
- 23 May 2019
- Last updated
- 5 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Single-dose, Parallel-group Study to Investigate the PK Profile of Single Dose Buprenorphine Transdermal Patch 20 mg Applied for 3 Days, 40 mg for 3 Days and 40 mg for 4 Days in Chinese Subjects With Chronic Pain
- ClinicalTrials.gov ID
- NCT03975010
- Acronym / sponsor ID
- BUP14-CN-101
- Conditions
- Chronic Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Mundipharma (China) Pharmaceutical Co. LtdIndustry (pharma, biotech, devices)
- Study start
- 13 May 2019 (actual)
- Primary completion
- 31 Mar 2020 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 5 Jun 2019 (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 an open-label, randomised, single-dose, 3 arms study design.
Detailed description
Subjects will be randomised into one of 3 arms, in a 1:1:1 ratio, wearing BUP TDS 20 mg for 3 days or 40 mg for 3 days or 40 mg for 4 days.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BUP TDS 20 mg for 3 days | Experimental | Drug: Buprenorphine Transdermal PatchSubjects will be randomized into the arms, use BUP TDS 20 mg for 3 days. |
| BUP TDS 40 mg for 3 days | Experimental | Drug: Buprenorphine Transdermal PatchSubjects will be randomized into the arms, use BUP TDS 40 mg for 3 days. |
| BUP TDS 40 mg for 4 day | Experimental | Drug: Buprenorphine Transdermal PatchSubjects will be randomized into the arms, use BUP TDS 40 mg for 4 days. |
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 chronic pain (regardless of the aetiology, cancer-pain excluded), aged 18-55 years (both inclusive).
- The average pain over the last 24 hours should attain ≤ 3 assessed with Numeric Rating Scales (NRS) refer to section 19.5. The pain condition has been lasting for at least 1 month and stable for 7 days prior to entering into the screening and is expected to be stable during the study duration.
- Patients on stable permissible non-opioid analgesics, who in the opinion of the investigator are unlikely to require a change in treatment during the study.
- Karnofsky score of Performance Status ≥ 70.
- Body mass index (BMI) of 19 to 28 kg/m2 (both inclusive); and a total body weight ≥ 50 kg.
Key exclusion criteria (31 listed)
- Unstable condition of the primary disease of chronic pain, which, in the opinion of the investigator, would complicate the subject's participation in the study (e.g. require initiation of new medication).
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies).
- History of seizures or at risk (i.e. head trauma, epilepsy in family, anamnesis, unclear loss of consciousness).
- Any history of frequent nausea or emesis regardless of aetiology.
- Malignancy or a history of malignancy.
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 |
|---|---|---|
| Buprenorphine Transdermal PatchAlso: Naltrexone HydrochlorideThis is an open-label, randomised, single-dose, 3 arms study design. Subjects will be randomised into one of 3 arms, in a 1:1:1 ratio, wearing BUP TDS 20 mg for 3 days or 40 mg for 3 days or 40 mg for 4 days. Safety follow-up will be planned at 7~9 days after patch removal. The study patch will be applied under the cover of naltrexone to reduce opioid related side-effects. Naltrexone 50 mg will be taken orally every 12 hours, from the evening of Day 00 (13 hours prior to IMP application), until the evening of the patch removal. | Drug | BUP TDS 20 mg for 3 days, BUP TDS 40 mg for 3 days, BUP TDS 40 mg for 4 day |
Primary outcome
To evaluate the pharmacokinetic profile of buprenorphine and its primary metabolite, norbuprenorphine_Cmax
Time frame: from Day0 to Day8 or Day9
Pharmacokinetic parameters of the prototype buprenorphine, and the primetabolite norbuprenorphine, calculated from plasma concentration-time data following a single application of BUP TDS 20 mg (3 days), 40 mg (3 days) and 40 mg (4 days).
To evaluate the pharmacokinetic profile of buprenorphine and its primary metabolite, norbuprenorphine_AUCt
Time frame: from Day0 to Day8 or Day9
Pharmacokinetic parameters of the prototype buprenorphine, and the primetabolite norbuprenorphine, calculated from plasma concentration-time data following a single application of BUP TDS 20 mg (3 days), 40 mg (3 days) and 40 mg (4 days).
To evaluate the pharmacokinetic profile of buprenorphine and its primary metabolite, norbuprenorphine_AUCinf
Time frame: from Day0 to Day8 or Day9
Pharmacokinetic parameters of the prototype buprenorphine, and the primetabolite norbuprenorphine, calculated from plasma concentration-time data following a single application of BUP TDS 20 mg (3 days), 40 mg (3 days) and 40 mg (4 days).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 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.
Wenping Wang, PhD principal investigator
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
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 Buprenorphine Transdermal Patch 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 31 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: status not confirmed, as of the sponsor's last update on 5 Jun 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Di Yang, Bachelor (86 10 65636798, Di.Yang@mundipharma.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the pharmacokinetic profile of buprenorphine and its primary metabolite, norbuprenorphine_Cmax (time frame: from Day0 to Day8 or Day9). 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 5 Jun 2019.