ADMIT-NeP Study

JRCT ID: jRCTs071200053

Registered date:17/11/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Neuropathic pain
• Date of first enrollment: 29/12/2020
• Target sample size: 150
• Study type: Interventional

Intervention(s)

Patients who meet the enrollment requirements are randomized by the enrollment system to one of the following treatment groups using the substitution block method (ratio 1:1). The VAS (less than 60 mm / 60 mm or more) at the enrollment (baseline) and institutions are the allocation adjustment factor.
1) Conventional treatment group: Administer NSAIDs or Acetaminophen (these can be combined) as described in the package insert.
2) Mirogabalin add-on therapy group: In addition to conventional treatment, Mirogabalin is administered as follows in accordance with renal function of a subject. The administration of Mirogabalin is started after the enrollment of Visit 1 and is continued for 8 weeks until Visit 6.
- For patients with creatinine clearance => 60 mL/min, Mirogabalin 5 mg is administered twice daily for the first week. For the 2nd week, Mirogabalin 10 mg is administered twice daily. From the 3rd week, the dose of Mirogabalin is increased to 15 mg twice daily unless there is no safety issue. Thereafter, the dose of Mirogabalin should be adjusted appropriately within the range of 10 mg twice daily to 15 mg twice daily depending on the safety symptoms.
- For patients with creatinine clearance => 30 mL/min and < 60 mL/min, Mirogabalin 2.5 mg is administered twice daily for the first week. For the 2nd week, Mirogabalin 5 mg is administered twice daily. From the 3rd week, Mirogabalin 7.5 mg is administered twice daily unless there is no safety issue. Thereafter, the dose of Mirogabalin should be adjusted appropriately within the range of 5 mg twice daily to 7.5 mg twice daily depending on the safety symptoms.
When discontinuing administration of Mirogabalin, the dose of Mirogabalin is decreased gradually and carefully as described in the package insert.

Outcome(s)

Primary Outcome

Amount of change in pain intensity (VAS)
Visual analog scale of pain at rest around the surgical wound; Amount of change in VAS (100 mm scale with 0 mm for no pain and 100 mm for the worst pain you can imagine) 8 weeks after registration

Secondary Outcome

(Effectiveness)
1)Percentage of patients with the following evaluation scales improved by 30% or more and 50% or more based on enrollment
- VAS of pain around the surgical wound at rest (after 8 weeks)
2)Percentage of patients with a rating scale of 12 or more based on enrollment
- S-LANSS (after 2 weeks, 4 weeks, 8 weeks)
3)Amount of change in the following evaluation scales based on enrollment
- VAS of pain at rest (after 1 day, 2 weeks, 4 weeks)
- VAS of pain when coughing (after 1 day, 2 weeks, 4 weeks, 8 weeks
- PDAS (after 8 weeks)
- EQ-5D-5L (after 8 weeks)
- VAS of sleeping disorder (after 1 day, 2 weeks, 4 weeks, 8 weeks)
4)Changes in the patient's general conditions (PGIC) (after 8 weeks)
5)Prevalence of chronic pain : Prevalence of chronic pain at 8 weeks and 12 weeks after enrollment in each treatment group.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)Patients aged 20 years or older at informed consent
2)Patients who had pneumonectomy
3)Patients the day or two days after removing the thoracostomy tube placed by pneumonectomy, at enrollment
4)Patients with more 40mm of VAS for pain at rest around the surgical wound at enrollment
5)Patients with hypoesthesia of the cutaneous sensation innervated by surgical wound intercostal nerve at enrollment*
6)Patients who were confirmed to have no residual effects of epidural anesthesia at enrollment*
7)Patients who obtained their voluntary written consent after received a sufficient explanation and understood this study
*Confirm 5) and 6) according to the separately defined "Procedure for Diagnosis of Peripheral Nerve Disorders after Surgery".

Exclude criteria

1)Patients who had prior extrapleural pneumonectomy or decortication
2)Patients who have severe liver function failure at enrollment
3)Patients have with hypersensitivity to drugs allergies
4)Patients have pregnant, possibly pregnant, breast-feeding
5)Patients who took neuropathic pain medication from 1 month before surgery to enrollment
6)Patients with history of thoracotomy or thoracoscopic surgery, and before pneumonectomy in this study, patients with neuropathy due to the surgical history
7) Patients with a creatinine clearance (Cockcroft-Gault formula) < 30 mL/min within 3 months of enrollment
8)Patients with a history of hypersensitivity of Mirogabalin Besilate
9)Patients who had preoperative chemotherapy within 2 months before surgery
10)Patients with severe pain outside of around the surgical wound at enrollment and for whom efficacy evaluation in this study is difficult
11)Patients who are inappropriate for this study judged by Principal investigator or Sub investigator because of some reasons

Related Information

• Primary Sponsor: Nagayasu Takeshi
• Source(s) of Monetary Support: DAIICHI SANKYO COMPANY, LIMITED
• Secondary ID(s): Nil known