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A Study to Evaluate Buprenorphine Transdermal Patch in Chinese Subjects With Moderate to Severe Chronic Cancer Pain

Unknown statusPhase 3NCT03967327
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

This is a randomised, active-controlled, double-blind, double-dummy, parallel group study with BUP TDS 20 mg (release rate 35 µg/h), 30 mg (release rate 52.5 µg/h) and 40 mg (release rate 70 µg/h), and MOR SR 60 mg, 100 mg or 120 mg per day. The study consists of 3 phases: a Pre-randomisation Phase, a Double-blind Phase and a Safety Follow-up Phase. There will be 194 subjects to be randomized, with 97 randomized subjects in each arm to ensure 154 evaluable (per protocol population) subjects in the study.

Study details

Official title
A Study to Evaluate the Efficacy and Safety of Buprenorphine Transdermal Patch Compared to Morphine Sulfate Sustained-release Tablet in Opioid Pre-treated Chinese Subjects With Moderate to Severe Chronic Cancer Pain
Conditions
Interventions
  • Drug: Buprenorphine transdermal patches
  • Drug: Morphine Sulfate Sustained-Release Tablet
Sponsor
Mundipharma (China) Pharmaceutical Co. Ltd
Start date
2019-04-22
Primary completion
2020-12-20
Sex
All
Age range
from 18 Years
Results posted
No results posted in this snapshot
Countries
China
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Male or female cancer subjects, 18 years of age or older. 2. Females less than one year post-menopausal must have a negative serum pregnancy test recorded at the screening visit, be non-lactating, and willing to use adequate and reliable contraception throughout the study. Highly effective (adequate and reliable) methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as sterilization, implants, injectables, combined oral contraceptives, some IUDs (intrauterine Device, hormonal), sexual abstinence or vasectomised partner. 3. Documented history of moderate to severe, chronic cancer pain that in the investigators' opinion requires around-the-clock opioid therapy in opioid pre-treated subjects and are likely to benefit from chronic opioid therapy through the administration of BUP TDS (20 mg, 30 mg or 40 mg) or MOR SR (60 mg/d, 100 mg/d or 120 mg/d) for the duration of the study. Subjects must be willing to discontinue their routine current opioid analgesic. 4. Subjects with inadequate therapeutic effect (inadequate analgesia or tolerability) with previous WHO step II opioids (weak opioids, e.g. tramadol, codeine) or WHO step III opioids (strong opioid) in the range of morphine equivalent dose level of 40 - 100 mg/d. • Moderate to severe inadequate pain at Screening visit (average pain over the last 24 hours ≥ 4 on the 0-10 NRS) 5. Estimated life expectancy ≥ 3 months. 6. Eastern Co-operative Group (ECOG) performance status of 0 - 2. 7. The antineoplastic therapies are not planned to be changed or added during the study. 8. Subjects willing and able to participate in all aspects for the study, including use of transdermal and oral medication, completion of subjective evaluations, attending scheduled clinic visits, completing telephone contacts, understanding and completing subject diary, and compliance with protocol requirements as evidenced by providing written informed consent. 9. In the investigators' opinion the subject's pre-study, non-opioid analgesics, and all other concomitant medications, including those medications for the treatment of depression, will remain stable throughout the double-blind phase of the study, and will be continued under the supervision of the investigator. 10. Subjects, who are able to read, understand and sign written informed consent prior to study participation and are willing to follow the protocol requiremen…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03967327