Cancer PainPhase 3NCT03967327
A Study to Evaluate Buprenorphine Transdermal Patch in Chinese Subjects With Moderate to Severe Chronic Cancer Pain
A Phase 3 study testing Buprenorphine transdermal patches and Morphine Sulfate Sustained-Release Tablet in people with Cancer Pain, run by Mundipharma (China) Pharmaceutical Co. Ltd at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Pain
- What is being tested?
- Buprenorphine transdermal patches and Morphine Sulfate Sustained-Release Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteChina
- Study dates
- 22 Apr 2019to 31 Dec 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female cancer subjects, 18 years of age or older.
- 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.
- 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.
- 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)
- Estimated life expectancy ≥ 3 months.
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- Eastern Co-operative Group (ECOG) performance status of 0 - 2.
- The antineoplastic therapies are not planned to be changed or added during the study.
- 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.
- 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.
- Subjects, who are able to read, understand and sign written informed consent prior to study participation and are willing to follow the protocol requirements.
Who cannot join
- Any history of hypersensitivity to buprenorphine, morphine, related products, other opioids and other ingredients.
- Subjects who have not received any opioids treatment, including WHO step II and step III opioids, for the treatment of cancer pain.
- Subjects receiving WHO step III opioids with more than 100 mg morphine-equivalent dose per day within the last 8 weeks before the screening visit.
- Subjects with any situation in which opioids are contra-indicated, severe respiratory depression with hypoxia and/or hypercapnia, severe chronic obstructive pulmonary disease, cor pulmonale, severe bronchial asthma, paralytic ileus, elevated carbon dioxide in the blood.
- Evidence of clinically significant cardiovascular, renal, hepatic, or psychiatric disease, as determined by medical history, clinical laboratory tests, Electrocardiogram (ECG) results, and physical examination, that will place the subject at risk upon exposure to the study treatment or that could confound the analysis and/or interpretation of the study results.
- Abnormal aspartate aminotransferase (AST; SGOT), alanine aminotransferase (ALT; SGPT), gamma-glutamyl transferase (GGT) or alkaline phosphatase levels (> 3 times the upper limit of normal) or an abnormal total bilirubin and/or creatinine level(s) (> 1.5 times the upper limit of normal), due to moderate to severe hepatic impairment and/or renal impairment, in the investigators' opinion.
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- Radiotherapy that, in the investigators' opinion, would influence pain during the study.
- Cyclic chemotherapy in the 2 weeks before the screening visit or planned during the study that has shown in the past to significantly influence pain assessment or safety profile of subjects (e.g. nausea, vomiting, diarrhoea). If subjects are having their first cycle of chemotherapy during the 2 weeks before the screening visit or during the study they should be excluded.
- Subjects with known or suspected unstable brain metastases or spinal cord compression that may require changes in systemic steroid treatment throughout the duration of the study.
- Subjects with uncontrolled seizures.
- Subjects with head injury, other intracranial lesions or a pre-existing increase in intracranial pressure.
- In the investigators' opinion, subjects who are receiving antihistamines, antipsychotics, anti-anxiety agents, hypnotics, phenothiazine or other central nervous system (CNS) depressants that may pose a risk of additional CNS depression with opioid study treatments.
- Subjects with myxoedema, not adequately treated hypothyroidism or Addison's disease.
- Surgery completed 2 months prior to the screening visit, or planned surgery during the study that may have influence on pain during the study or preclude completion of the study.
- Subjects receiving opioid substitution therapy for opioid addiction (e.g. methadone or buprenorphine).
- Subjects with active alcohol or drug abuse and/or history of opioid abuse.
- Subjects who participated in a clinical research study involving a new chemical entity or an experimental drug within 30 days of study entry (defined as the start of the Screening Period). Concurrent enrolment in another clinical trial is not permitted unless the sole purpose of the other trial at the time of the screening period is for collection of long-term follow-up/survival data.
- Subjects taking MAO-inhibitors within 14 days prior to screening visit or throughout the study.
- 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 was to be applied (e.g. dermatitis, burns, 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.
- Additional Inclusion Criteria for Entry to Double-blind Phase:
- Subjects continue to satisfy inclusion criteria.
- Subject's daily MOR SR dose must be 60, 100 or 120 mg/d.
- The MOR SR dose has been stable for at least one week prior to randomisation.
- Subjects have achieved pain control for each day of the week before randomisation, except occasionally (no more than 3 days within the week) pain not controlled due to accidental activities or events.
- Subjects must rate their pain (average pain over the last 24 hours based on PIS) as ≤ 3 on a 0-10 NRS with ≤ 2 doses of rescue medication for the day prior to randomisation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The 81st hospital of the people's liberation army
Nanjing
Shukui Qin
About this study
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
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.
Read the detailed description
AE data are obtained by the Investigators through observation of the Subject (including examinations and investigations), from any information volunteered by the Subject and through active questioning. At each visit after informed consent has been signed, Subjects will be asked about AEs that occurred since the last visit by questioning them with regard to their well-being by "non-leading" questions. This includes AEs occurring during the administration of IMP, as well as changes in concomitant diseases (e.g. ongoing medical history). The general type of questions could be similar to "Do you have any health problems?" or "Have you had any health problems since your last clinic visit?" During blinded studies, the Subject and all personnel involved with the conduct and interpretation of the study, including the Investigators, site personnel, and the Sponsor's staff, those involved in processing and regulatory reporting of SUSARs, will be blinded to the treatment codes until unblinding. The randomisation schedule will be filed securely by the Sponsor/IRS provider in a manner such that blinding is properly maintained throughout the study. Treatment codes will not be available until unblinding, after completion of the study and data base lock, except in the case of emergency.
Statistical analyses will be performed by a designated CRO. All statistical analyses will be performed using SAS and/or other statistical software as required.
- Conditions
- Cancer Pain
- Being tested
- Buprenorphine transdermal patches, Morphine Sulfate Sustained-Release Tablet
- Medical subject headings
- Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buprenorphine transdermal patchesDrug
It should be applied to non-irritated, intact skin of the upper outer arm, upper chest, upper back or the side of the chest. The skin should be relatively hairless. If none are available, the hair at the site should be clipped, not shaven.
Morphine Sulfate Sustained-Release TabletDrug
It will be administered orally twice (q12h) daily.
| Study group | Role | What they receive |
|---|---|---|
| MOR SR | Active comparator | This arm includes MOR SR and placebo for BUP TDS, detailed information is as below:
Treatment dosage form dosage frequency duration MOR SR Tablet 10,30,60mg q12h 8 weeks
Placebo for Patch -- every 3-4 days 8 weeks BUP TDS Receives: Drug: Buprenorphine transdermal patches; Drug: Morphine Sulfate Sustained-Release Tablet |
| BUP TDS | Experimental | This arm includes BUP TDS and placebo for MOR SR, detailed information is as below:
Treatment dosage form dosage frequency duration Placebo for Tablet -- q12h 8 weeks MOR SR
BUP TDS Patch 20/30/40mg every 3-4 days 8 weeks Receives: Drug: Buprenorphine transdermal patches; Drug: Morphine Sulfate Sustained-Release Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Pain Inventory - Short Form (BPI-SF)
- To demonstrate the therapeutic non-inferiority of buprenorphine transdermal patches (BUP TDS) compared to morphine sulfate sustained-release tablets (MOR SR) for the management of chronic cancer pain as assessed by the average pain over the last 24 hours on the numeric rating scale (NRS, 0-10) using the Brief Pain Inventory - Short Form (BPI-SF) (Cleeland \& Ryan, 1994)
- Moderate to severe inadequate pain at Screening visit (average pain over the last 24 hours ≥ 4 on the 0-10 NRS)
Measured: From visit 3 to study completion, as assessed up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start22 Apr 2019
- Primary completion20 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mundipharma (China) Pharmaceutical Co. Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shukui Qin, Principal investigator, The 81st hospital of the people's liberation army
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03967327
- Sponsor's protocol ID
- BUP14-CN-301
- Status last verified
- Jun 2019
- First submitted
- 15 May 2019
- Last updated
- 11 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03967327
- Acronym / sponsor ID
- BUP14-CN-301
- Conditions
- Cancer Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- Mundipharma (China) Pharmaceutical Co. LtdIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2019 (actual)
- Primary completion
- 20 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 30 May 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 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.
Detailed description
AE data are obtained by the Investigators through observation of the Subject (including examinations and investigations), from any information volunteered by the Subject and through active questioning. At each visit after informed consent has been signed, Subjects will be asked about AEs that occurred since the last visit by questioning them with regard to their well-being by "non-leading" questions. This includes AEs occurring during the administration of IMP, as well as changes in concomitant diseases (e.g. ongoing medical history). The general type of questions could be similar to "Do you have any health problems?" or "Have you had any health problems since your last clinic visit?" During blinded studies, the Subject and all personnel involved with the conduct and interpretation of the study, including the Investigators, site personnel, and the Sponsor's staff, those involved in processing and regulatory reporting of SUSARs, will be blinded to the treatment codes until unblinding. The randomisation schedule will be filed securely by the Sponsor/IRS provider in a manner such that blinding is properly maintained throughout the study. Treatment codes will not be available until unblinding, after completion of the study and data base lock, except in the case of emergency.
Statistical analyses will be performed by a designated CRO. All statistical analyses will be performed using SAS and/or other statistical software as required.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MOR SR | Active comparator | Drug: Buprenorphine transdermal patches, Drug: Morphine Sulfate Sustained-Release TabletThis arm includes MOR SR and placebo for BUP TDS, detailed information is as below: Treatment dosage form dosage frequency duration MOR SR Tablet 10,30,60mg q12h 8 weeks Placebo for Patch -- every 3-4 days 8 weeks BUP TDS |
| BUP TDS | Experimental | Drug: Buprenorphine transdermal patches, Drug: Morphine Sulfate Sustained-Release TabletThis arm includes BUP TDS and placebo for MOR SR, detailed information is as below: Treatment dosage form dosage frequency duration Placebo for Tablet -- q12h 8 weeks MOR SR BUP TDS Patch 20/30/40mg every 3-4 days 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female cancer subjects, 18 years of age or older.
- 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.
- 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.
- 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.
- Estimated life expectancy ≥ 3 months.
Key exclusion criteria (27 listed)
- Any history of hypersensitivity to buprenorphine, morphine, related products, other opioids and other ingredients.
- Subjects who have not received any opioids treatment, including WHO step II and step III opioids, for the treatment of cancer pain.
- Subjects receiving WHO step III opioids with more than 100 mg morphine-equivalent dose per day within the last 8 weeks before the screening visit.
- Subjects with any situation in which opioids are contra-indicated, severe respiratory depression with hypoxia and/or hypercapnia, severe chronic obstructive pulmonary disease, cor pulmonale, severe bronchial asthma, paralytic ileus, elevated carbon dioxide in the blood.
- Evidence of clinically significant cardiovascular, renal, hepatic, or psychiatric disease, as determined by medical history, clinical laboratory tests, Electrocardiogram (ECG) results, and physical examination, that will place the subject at risk upon exposure to the study treatment or that could confound the analysis and/or interpretation of the study results.
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 patchesIt should be applied to non-irritated, intact skin of the upper outer arm, upper chest, upper back or the side of the chest. The skin should be relatively hairless. If none are available, the hair at the site should be clipped, not shaven. | Drug | BUP TDS, MOR SR |
| Morphine Sulfate Sustained-Release TabletIt will be administered orally twice (q12h) daily. | Drug | BUP TDS, MOR SR |
Primary outcome
Brief Pain Inventory - Short Form (BPI-SF)
Time frame: From visit 3 to study completion, as assessed up to 8 weeks
* To demonstrate the therapeutic non-inferiority of buprenorphine transdermal patches (BUP TDS) compared to morphine sulfate sustained-release tablets (MOR SR) for the management of chronic cancer pain as assessed by the average pain over the last 24 hours on the numeric rating scale (NRS, 0-10) using the Brief Pain Inventory - Short Form (BPI-SF) (Cleeland \& Ryan, 1994) * Moderate to severe inadequate pain at Screening visit (average pain over the last 24 hours ≥ 4 on the 0-10 NRS)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2019.
- Individual participant dataSharing planned: No
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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.
Shukui Qin principal investigator
The 81st hospital of the people's liberation army
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 Buprenorphine transdermal patches and Morphine Sulfate Sustained-Release Tablet in people with Cancer 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 11 inclusion and 27 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 11 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guodong Lu (8610-65636856, guodong.lu@mundipharma.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Pain Inventory - Short Form (BPI-SF) (time frame: From visit 3 to study completion, as assessed up to 8 weeks). 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 11 Jun 2019.