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DS-7113b phase III study

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

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222239
Enrollment
Unknown
Registered
2013-09-30
Start date
2013-09-30
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 INN of investigational material : Hydromorphone hydrochloride Therapeutic category code : 811 Opium alkaloids preparations Dosage and Administra

Sponsors

DAIICHISANKYO Co.,Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Cancer pain patients meeting any of followings -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 -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 -Patients who prefer to take DS-7113b IR tabletsafter completion of the study treatment of DS7113-A-J301 trial

Exclusion criteria

Exclusion criteria: Patients with symptom(s)/finding(s) falling under the contraindications or relative contraindications stated in the package insert of 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