Miro-Canp

Phase 4

Recruiting

• Conditions: europathic cancer pain

• Registration Number: JPRN-jRCTs031220569
• Lead Sponsor: Hashiguchi Saori

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-13
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

1. Patients with a confirmed diagnosis of various types of cancer..
2. Patients using opioid analgesics (morphine sulfate hydrate, morphine hydrochloride hydrate, oxycodone hydrochloride hydrate, hydromorphone hydrochloride, fentanyl patch, fentanyl citrate patch) for their cancer pain.
3. Patients with neuropathic cancer pain.*
4. Patients with a maximum NRS of 4 or higher for neuropathic cancer pain in the 24 hours before enrollment.
5. Patients who are 18 years of age or older at the time of obtaining consent.
6. Patients whose ECOG PS at the time of enrollment is 3 or less.
7. Patients who are not planed to change their cancer treatment during the study period.
8. Patients who can understand the procedure of this study, answer questions in Japanese appropriately in writing and by electromagnetic means (ePRO) without assistance, and give their own written consent on their own free will to participate in this study by writing or electromagnetic means (eConsent).

*:
-Neurological examination reveals objective findings of sensory disturbance (Hypoesthesia, hyperalgesia, allodynia, etc.) observed in areas consistent with the anatomical innervation of the damaged nerve.
-Neuropathic lesions or diseases explaining neuropathic pain are observed by imaging tests, neurophysiological tests, etc.

Exclusion Criteria

1. Patients whose latest creatinine clearance (CLcr) is less than 30 mL/min.
2. Patients with a history of hypersensitivity to components of milogabalin, pregabalin, or gabapentin.
3. Patients planned to undergo surgery, spinal cord stimulation and palliative radiation therapy during the study.
4. Patients with serious liver disease, kidney disease or heart disease.
5. Patients who have taken milogabalin within 28 days before consent is obtained.
6. Patients who are or may be pregnant at the time of obtaining consent, patients breastfeeding at the time of obtaining consent, or patients intending to become pregnant within six months of obtaining consent.
7. Patients participating or planned to participate in other intervention studies at the time of enrollment.
8. Patients who have used rescue medication at 4 or more times a day in the 2 days prior to enrollment.
9. Other patients deemed unsuitable by investigators for participation in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in pain NRS from enrollmeny to week 4

Secondary Outcome Measures

Name	Time	Method
1. Daily changes in pain NRS<br>2. Responder rate (30% or 50% improvement in NRS, 3 or less of NRS)<br>3. Change in opioid dose (equivalent to oral morphine)<br>4. Changes in the number of using rescue drug<br>5. Change in EQ-5D-5L score<br>6. Change in Neuropathic Pain Symptom Inventory (NPSI) score <br>7. Change in Pain DETECT score<br>8. Patient Global Impression of Change<br>9. Daily changes in sleep disturbance NRS<br>10. Continuation rate of cancer pain drugs