ONO-2910-02: A Phase IIa Study of ONO-2910 in Patients with Diabetic Polyneuropathy

JRCT ID: jRCT2061210008

Registered date:28/05/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Diabetic polyneuropathy
• Date of first enrollment: 24/06/2021
• Target sample size: 168
• Study type: Interventional

Intervention(s)

The IMP is administered as follows according to the assigned administration group.
- ONO-2910 group: Take ONO-2910 tablets once a day.
- Placebo group: Take placebo tablets once daily.

Outcome(s)

Primary Outcome

Efficacy:
Change from baseline at week 12 in the total score of the Numbness and Tingling of the modified Toronto Clinical Neuropathy Scale (mTCNS).
Safety:
Adverse events, Physical findings (body weight), Vital signs, 12-lead electrocardiogram, Clinical laboratory test
Pharmacokinetics:
Plasma concentration of ONO-2910

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 75age old
• Gender: Both

Include criteria

1. Type 2 diabetes with HbA1c : >= 6.5%, <= 10.0%
2. Patients diagnosised with diabetic polyneuropathy (DPN) by "simplified diagnostic criteria for diabetic polyneuropathy" proposed by "the Conference on Diabetic Polyneuropathy"
3. Patients suffering from Numbness and Tingling on both feet and their mTCNS score are >= 2 each.

Exclude criteria

1. Patients who are expected to change treatment methods (drug therapy, exercise therapy, etc.) for diabetes during the study period
2. Patients who are expected to newly take or change the dosage and administration of peripheral neuropathic pain medication, other analgesics, or agents for overall symptoms of DPN during the study period
3. Patients with pain or numbness other than DPN in upper or lower limbs

Related Information

• Primary Sponsor: Hirashima Yoshinori