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

ONO-2910-02: A Phase IIa Study of ONO-2910, Randomised, Double-blind, Placebo Controlled, Parallel Group, Multi-center Trial in Patients with Diabetic Polyneuropathy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2061210008

Enrollment

168

Registered

2021-05-28

Start date

2021-06-24

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic polyneuropathy

Interventions

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.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Type 2 diabetes with HbA1c : >= 6.5%, = 2 each.

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
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	—

Contacts

Public ContactCenter Medical

Ono Pharmaceutical Co.,LTD

clinical_trial@ono-pharma.com+81-120626190

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026