Condition or disease | Intervention/treatment | Phase |
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Chronic Pain | Drug: Buprenorphine Transdermal Patch | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 45 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
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 |
Actual Study Start Date : | May 13, 2019 |
Estimated Primary Completion Date : | March 31, 2020 |
Estimated Study Completion Date : | March 31, 2020 |
Arm | Intervention/treatment |
---|---|
Experimental: BUP TDS 20 mg for 3 days
Subjects will be randomized into the arms, use BUP TDS 20 mg for 3 days.
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Drug: Buprenorphine Transdermal Patch
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. Other Name: Naltrexone Hydrochloride
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Experimental: BUP TDS 40 mg for 3 days
Subjects will be randomized into the arms, use BUP TDS 40 mg for 3 days.
|
Drug: Buprenorphine Transdermal Patch
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. Other Name: Naltrexone Hydrochloride
|
Experimental: BUP TDS 40 mg for 4 day
Subjects will be randomized into the arms, use BUP TDS 40 mg for 4 days.
|
Drug: Buprenorphine Transdermal Patch
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. Other Name: Naltrexone Hydrochloride
|
Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Di Yang, Bachelor | 86 10 65636798 | Di.Yang@mundipharma.com.cn | |
Contact: Rongna A, Master | 86 10 65636885 | Rongna.A@mundipharma.com.cn |
China, Liaoning | |
The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine | Recruiting |
Shenyang, Liaoning, China | |
Contact: Wenping Wang, Doctor 86 24 31961971 wangwenping@hotmail.com |
Principal Investigator: | Wenping Wang, PhD | The affiliated hospital of Liaoning University of Traditional Chinese Medicine |
Tracking Information | |||||
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First Submitted Date ICMJE | May 23, 2019 | ||||
First Posted Date ICMJE | June 5, 2019 | ||||
Last Update Posted Date | June 5, 2019 | ||||
Actual Study Start Date ICMJE | May 13, 2019 | ||||
Estimated Primary Completion Date | March 31, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Buprenorphine Transdermal Patches Pharmacokinetic Study | ||||
Official Title ICMJE | 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 | ||||
Brief Summary | 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 Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Basic Science |
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Condition ICMJE | Chronic Pain | ||||
Intervention ICMJE | Drug: Buprenorphine Transdermal Patch
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. Other Name: Naltrexone Hydrochloride
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
45 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | March 31, 2020 | ||||
Estimated Primary Completion Date | March 31, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 55 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03975010 | ||||
Other Study ID Numbers ICMJE | BUP14-CN-101 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Mundipharma (China) Pharmaceutical Co. Ltd | ||||
Study Sponsor ICMJE | Mundipharma (China) Pharmaceutical Co. Ltd | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Mundipharma (China) Pharmaceutical Co. Ltd | ||||
Verification Date | June 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |