Exploratory study about the influence of drug administration guidance on patients satisfaction with treatment after administration of Mirogabalin

JRCT ID: jRCTs041230059

Registered date:13/07/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Neuropathic pain due to orthopedic diseases
• Date of first enrollment: 24/07/2023
• Target sample size: 200
• Study type: Interventional
• Intervention(s): Patients with neuropathic pain due to orthopedic diseases are treated with oral mirogabalin besilate tablets for 8 weeks. Patients with neuropathic pain due to orthopedic diseases are provided with patient compliance instruction using a unified method.

Outcome(s)

• Primary Outcome: Patient treatment satisfaction

Secondary Outcome

1. Factors affecting patient treatment satisfaction.
2. Association Between Disease/Medication Understanding and Patient Treatment Satisfaction at Week 8.
3. Association between disease/drug comprehension and various items at Week 8
4. Change from baseline in disease/drug comprehension (Week 8)
5. Association between physician treatment satisfaction and various items.
6. Concordance between patients and physicians with various items. 8. Adverse events (TEAE)

Key inclusion & exclusion criteria

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

Include criteria

1. Patients diagnosed with neuropathic pain due to orthopedic disorders
2. First patient treated with a neuropathic pain medication
3. Patients who are scheduled to continue treatment for at least 8 weeks and are able to attend the relevant medical institution
4. Patients aged 18 years or older at the time of obtaining informed consent
5. 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)

Exclude criteria

1. Patients who are considered to require inpatient treatment at the time of study entry
2. Patients scheduled to undergo surgery during the study period
3. Patients with severe pain attributable to a disease other than the relevant disease and considered difficult to evaluate.
4. Patients with creatinine clearance (CLcr) <30 mL/min
5. Patients with complicated serious liver, kidney, and heart disease
6. Patients who are pregnant or possibly pregnant at the time of obtaining informed consent, patients who are breastfeeding at the time of obtaining informed consent, and patients who intend to become pregnant within 6 months after obtaining informed consent
7. Patients participating in or planned to participate in other intervention studies at enrollment
8. Other patients judged by the principal investigator or subinvestigator to be ineligible for participation in this study

Related Information

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