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

Opioid Titration With 12.5 ug/h Fentanyl Transdermal Patch vs Orally Morphine for Opioid-naïve Patients With Moderate Cancer Pain: A Prospective, Randomized, Controlled, Multi-center, Phase III Trial

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.

Study Overview

• Status: Unknown
• Conditions: Opioid, Moderate Cancer Pain, Transdermal Fentanyl, 12.5ug/h, Opioid-naive
• Intervention / Treatment: Drug: 2.5ug/h transdermal fentanyl; Drug: Oral immediate-released morphine

• Study Type: Interventional
• Enrollment (Anticipated): 209
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 2.5ug/h transdermal fentanyl	Drug: 2.5ug/h transdermal fentanyl; 2.5ug/h transdermal fentanyl administers for opioid-naive patients with moderate cancer pain very 3 days
ACTIVE_COMPARATOR: Oral immediate-released morphine	Drug: Oral immediate-released morphine; 5mg immediate-released morphine every 4 hours, double dose before sleep.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the number of responder patients	the number of responder patients is defined as patientswith a 20% reduction in pain intensity on the numerical rating scale.	12 months

Collaborators and Investigators

• Sponsor: Fujian Cancer Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2020
• Primary Completion (ANTICIPATED): August 31, 2022
• Study Completion (ANTICIPATED): August 31, 2022

Study Registration Dates

• First Submitted: August 26, 2020
• First Submitted That Met QC Criteria: August 26, 2020
• First Posted (ACTUAL): August 31, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 31, 2020
• Last Update Submitted That Met QC Criteria: August 26, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Cancer Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl; Morphine
• Other Study ID Numbers: SYLT-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No