To evaluate the efficacy and safety of 14-day multiple oral doses of S-297995 in cancer patients with opioid analgesic-induced constipation in the multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Pharmacokinetics are also assessed.

A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of S-297995 for the Treatment of Opioid-induced Constipation (OIC) in Cancer Patients

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0000409

Enrollment

Registered

2012-04-20

Start date

2012-06-08

Completion date

Unknown

Last updated

2019-03-11

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

Conditions

None listed

Interventions

Drug : - Name of drug: S-297995 0.1mg tablet or placebo tablet - Dosage: S-297995 0.1mg, 0.2mg, 0.4mg or placebo tablet - Number of administration: once daily - Treatment period: 14 days - Administrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Cancer patients with constipation associated with administration of opioid analgesics who meet the following criteria: Patients whose SBM (spontaneous bowel movement) frequency during the 14 days prior to enrollment is 5 times or less, and who experience at least one of the following symptoms of bowel movements - Straining during bowel movement - Feeling of incomplete evacuation - Passage of hard stools or pellets etc.

Exclusion criteria

Exclusion criteria: Patients with constipation potentially attributable to causes other than opioid analgesics Patients with clinically significant gastrointestinal disorders Patients with hepatic or renal disorders, etc

Design outcomes

Primary

Measure	Time frame
To compare the efficacy of S-297995 with that of placebo using the change in the frequency of spontaneous bowel movements per week from the baseline during 14-days once-daily oral administration.	—

Countries

Korea, Republic of

Contacts

Public ContactYong Chul Kim

Seoul National University Hospital

Outcome results