A phase 3 study for S-8117 (OTR) switched from oxycodone hydrochloride controlled-release tablets in patients with chronic pain

An open-label, efficacy, safety and pharmacokinetic study for S-8117 (OTR) switched from oxycodone hydrochloride controlled-release tablets in patients with chronic pain

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223929

Enrollment

Registered

2018-06-05

Start date

2018-07-23

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

Chronic pain

Interventions

investigational material(s) Generic name etc : S-8117 (OTR) INN of investigational material : Oxycodone hydrochloride Therapeutic category code : 811 Opium alkaloids preparations Dosage and Administra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients suffer from pain which has sustained for 12 weeks or more, has diagnosed as chronic pain such as chronic low back pain, osteoarthritis, diabetic neuropathic pain, postherpetic neuralgia. etc.

Exclusion criteria

Exclusion criteria: - Patients with previous or present allergy or hypersensitivity to opium alkaloids. - Patients with absolute or relative contraindications to oxycodone or morphine preparations. etc.

Design outcomes

Primary

Measure	Time frame
efficacy The pain control maintenance rate	—

Secondary

Measure	Time frame
safety pharmacokinetics - Pharmacokinetic endpoint: Plasma oxycodone concentration just before administration. - Safety endpoints: AEs and adverse drug reactions and the frequencies. etc.	—

Countries

Japan

Outcome results

None listed

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