Opioid Titration With 12.5 ug/h Fentanyl Transdermal Patch vs Orally Morphine for Opioid-naïve Patients With Moderate Cancer Pain

NCT ID: NCT04533243

Last Updated: 2020-08-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 209 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2022-08-31

Brief Summary

Opioid is recommended for moderate cancer pain in WHO 3-step analgesic ladder. Transdermal administration of the strong opioid fentanyl was originally developed for patients unable to swallow analgesics because of malignancies in the head and neck region or the gastrointestinal tract, painful lesions in the mouth, or periods of nausea, vomiting, or bowel obstruction. The EMA recognizes that in exceptional clinical circumstances, the 12 μg/h fentanyl patch could be considered. To our knowledge, there is not a phase III trial to explore the efficacy and safety of 12 μg/h fentanyl patch in opioid-naive patients with moderate cancer pain.

Conditions

Opioid, Moderate Cancer Pain, Transdermal Fentanyl, 12.5ug/h, Opioid-naive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

2.5ug/h transdermal fentanyl

Group Type: EXPERIMENTAL

2.5ug/h transdermal fentanyl

Intervention Type: DRUG

2.5ug/h transdermal fentanyl administers for opioid-naive patients with moderate cancer pain very 3 days

Oral immediate-released morphine

Group Type: ACTIVE_COMPARATOR

Oral immediate-released morphine

Intervention Type: DRUG

5mg immediate-released morphine every 4 hours, double dose before sleep.

Interventions

2.5ug/h transdermal fentanyl

2.5ug/h transdermal fentanyl administers for opioid-naive patients with moderate cancer pain very 3 days

Intervention Type: DRUG

Oral immediate-released morphine

5mg immediate-released morphine every 4 hours, double dose before sleep.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age 18 years old or more;

2. ECOG PS ≤3 ;

3. Opioid tolerance not moderate pain patients (4≤ NRS ≤6 on 11 points, 0 no pain, 10 most pain);

4. No taking strong opioids for the last 30 days;

5. Estimated life expectancy of at least 3 months;

6. Ability to communicate effectively with the study personnel about the nature of their pain;

7. Ability to complete a diary;

8. Cancer pain is expected to be relatively stable and last for more than 48 hours;

9. The patient understands the research process, agrees to participate in the trial, cooperates with the treatment and visit plan, and signs an informed consent form.

Exclusion Criteria

1. Known allergy to any ingredient in both fentanyl and morphine;

2. No cancer associated pain or the pain of unknown cause, such as osteoarthritis pain, acute abdominal pain;

3. Primary tumors or metastases in the brain;

4. An active skin disease that precluded application of the transdermal system;

5. Anti-cancer therapy (radiotherapy, chemotherapy, targeted therapy, etc.) is used during the study period, and the treatment has an impact on the analgesic effect or adverse reactions of analgesic drugs;

6. No bowel movement within 3 days before the screening period;

7. The patient has contraindications to the use of opioids: such as respiratory depression; head damage; paralytic intestinal obstruction; acute abdomen; chronic obstructive airway disease; pulmonary heart disease; chronic bronchial asthma; hypercapnia;

8. Used monoamine oxidase inhibitor within 1 week before randomization;

9. Any abnormal laboratory test results with obvious clinical significance, such as creatinine value ≥ 2 times the high limit of the normal value or ALT or AST ≥ 2.5 times the high limit of the normal value (for patients with liver metastases can be relaxed to ≥ 5 times the high limit of the normal value) ;

10. Patients with a history of drug abuse;

11. Patients with mental illness or cognitive impairment;

12. Pregnant or lactating women; subjects who have a pregnancy plan within 1 month after the test (including male subjects);

13. Participate in the drug trial (including the trial drug) within 3 months before the trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

SYLT-19

Identifier Type: -

Identifier Source: org_study_id