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DS-7113b phase III study

DS-7113b extended-release (ER) tablet phase III study-A DS-7113b extended-release tablet long-term study in patients with cancer pain-

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222616
Enrollment
Unknown
Registered
2014-09-30
Start date
2014-09-30
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

Moderate to severe cancer pain

Interventions

investigational material(s) Generic name etc : DS-7113b ER tablet INN of investigational material : Hydromorphone hydrochloride Therapeutic category code : 811 Opium alkaloids preparations Dosage and

Sponsors

DAIICHISANKYO Co.,Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Cancer pain patients meeting any of following 1) Patients on opioid analgesics (oral morphine, oral oxycodone, transdermal fentanyl, or tramadol) less than 240 mg in morphine equivalent and judged effective to be treated with strong opioid analgesics 2) Patients who have not been on opioid analgesics, whose VAS is 35 mm and over and judged necessary to be treated with strong opioid analgesics 3) Patients who prefer to take DS-7113b ER tablets after completion of the study treatment of DS7113-B-J303 trial

Exclusion criteria

Exclusion criteria: Patients with symptom(s)/finding(s) falling under the contraindications or relative contraindications stated in the package insert of oral oxycodone hydrochloride and morphine hydrochloride, etc.

Design outcomes

Primary

MeasureTime frame
Efficacy rate (post-switch improvement and analgesia improvement ) at each visit and early termination visit—

Secondary

MeasureTime frame
Pain Intensity (PI), efficacy and safety—

Outcome results

None listed

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