Miro-Canp

JRCT ID: jRCTs031220569

Registered date:13/01/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Neuropathic cancer pain
• Date of first enrollment: 30/03/2023
• Target sample size: 140
• Study type: Interventional
• Intervention(s): Comparing a group taking mirogabalin add-on therapy to opioids with a group taking opioids therapy in regard to patients who have neuropathic cancer pain.

Outcome(s)

• Primary Outcome: Change in pain NRS from enrollmeny to week 4

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Hashiguchi Saori
• Source(s) of Monetary Support: Daiichi Sankyo Co., Ltd