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A double-blind, placebo-controlled study of S-8117 in patients with chronic low back pain

A double-blind, placebo-controlled study of S-8117 in patients with chronic low back pain

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222250
Enrollment
Unknown
Registered
2013-10-07
Start date
2013-10-07
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 low back pain

Interventions

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

Sponsors

SHIONOGI & CO., LTD.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with low back pain for at least 12 weeks, and the pain is diagnosed as chronic low back pain caused by nonmalignant disorder. And etc.

Exclusion criteria

Exclusion criteria: Patients with previous or present allergy or hypersensitivity to opium alkaloids. Patients who participated in a clinical trial of S-8117 previously and received S-8117. And etc.

Design outcomes

Primary

MeasureTime frame
Time to insufficient analgesic response during the double-blind phase.—

Outcome results

None listed

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