Randomized, crossover trial of comparing two transdermal fentanyl matrix patches, Matrifen? and Durogesic D-trans? in cancer pai

Not Applicable

Completed

• Conditions: Neoplasms

• Registration Number: KCT0003153
• Lead Sponsor: Gyeongsang National University Hospital

Brief Summary

This study registered a total of 100 participants from March 2019 to August 2021. They were randomly assigned to either the matrifen or durogesic group, with 50 individuals in each. The median age was 61.5 years for the matrifen group and 66 years for the durogesic group, showing no statistically significant difference. Men constituted 73% of participants, with no difference between the groups. The most common type of cancer was pancreaticobiliary cancer at 40%, followed by colorectal and urogenital cancers at 15% and 8%, respectively. At the time of registration, more participants in the matrifen group were undergoing chemotherapy, whereas more in the durogesic group were receiving conservative treatment. The baseline morphine equivalent daily dose (MEDD) averaged 66 mg for matrifen and 108 mg for durogesic, with the latter being higher. The average dose for fentanyl patches was also higher in the durogesic group, at 31 ug/hr and 49 ug/hr, respectively. More participants in the matrifen group applied the patch to the upper limbs. Both matrifen and durogesic patches were effective in managing cancer pain. When comparing the first and sixth days of the trial, the average 24-hour Numeric Rating Scale (NRS) for pain significantly decreased from 3.8 to 2.7 in the matrifen group, and from 3.4 to 2.7 in the durogesic group. The NRS for breakthrough pain also significantly decreased from 5.0 to 4.2 in the matrifen group and from 5.0 to 3.5 in the durogesic group. The average number of breakthrough pain episodes decreased from 1.3 to 1.0 in the matrifen group and from 2.1 to 1.2 in the durogesic group. However, there was no significant difference between the two groups in terms of the 24-hour average pain NRS, breakthrough pain NRS, and frequency on the sixth day of the trial. The frequency of end-of-dose failure was slightly lower in the matrifen group (4.3%) compared to the durogesic group (10.6%), but this difference was not statistically significant. Satisfaction on the sixth day of the trial, the primary research objective, showed almost identical results in both groups (median value 2, average value 2.3). The average adhesion score on the sixth day was 0.3 for matrifen and 0.04 for durogesic, showing a statistically significant difference. However, this difference was deemed clinically negligible. No correlation was found between the differences in baseline characteristics (treatment status, MEDD, fentanyl patch dose, patch application site) and adhesion. Patch detachment occurred in 4.3% of the matrifen group and 10.6% of the durogesic group, with no significant statistical difference. All reported drug-related side effects in both groups were grade 1-2, with no reports of grade 3 or higher. Reported side effects included nausea, vomiting, somnolence, dizziness, itching sensation, dry mouth, and constipation. A total of 6 participants, three from each group, dropped out of the study, with only one from the durogesic group leaving due to side effects. Both matrifen and durogesic patches demonstrated good tolerability and excellent analgesic effects. Adhesion was also excellent in both groups, which likely contributed to the high satisfaction ratings among participants. Although there was no statistical significance, matrifen showed a slightly more favorable profile in terms of patch detachment frequency and end-of-dose failure. The relatively small number of participants and the lower average pain intensity might have contributed to the lack of significant differences between the groups, allowing for the clinical non-inferiority of matrifen to be observed in this study.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-10-28
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. 19 + at the time of screening
2. A study subject who uses durogesic patch more than 12 mcg as a pain in cancer cells, which has been confirmed systematically
3. The study participants with a numerical evaluation grade 4 or less of the average pain severity
4. A person who has sufficient communication with the clinician about his or her pain
5. Participants who understand the purpose of the study and who have written consent

Exclusion Criteria

1. Subjects with a breakthrough pain greater than or equal to a numeric rating of 5 and a frequency of more than 4 times a day
2. Subjects with delirium
3. The components of Fentanyl, the hypersensitivity reaction to other adipose drugs, and the study subjects
4. Those who have no experience in administering narcotics or have no resistance to narcotics
5. Subjects who had organic impairment or damage such as increased intracranial pressure, consciousness disorder, and coma
6. Participants in research on severe chronic closed diseases
7. Subject to an asthma attack persistence study
8. Subjects with paralytic ileus
9. Person subject to research within 2 weeks of administration or withdrawal of administration of MAO inhibitor

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of satisfaction with Matrifen vs. Durogesic

Secondary Outcome Measures

Name	Time	Method
End-of-dose failure frequency between two drugs;Attachment force evaluation;Number and intensity of Sudden pain;Evaluation of preference between two drugs