Prospective Observational Study on Opioid-induced Constipation in Patients with Cancer Pain in Japan

Prospective Observational Study on Opioid-induced Constipation in Patients with Cancer Pain in Japan - Prospective Observational Study on Opioid-induced Constipation in Patients with Cancer Pain in Japan

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000025864

Enrollment

220

Registered

2017-01-26

Start date

2017-01-27

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

Opioid-induced constipation

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Age at the time of informed consent: 20 years or older (2) Male and Female, inpatient and outpatient (3) Patients who did not have previous opioid analgesic treatment (4) Patients who are able to receive oral intake of drugs, food, and beverages (5) Patients who are able to walk and perform daily activities without assistance: performance status (PS) between 0 and 2 (6) Patients who are able to perform a self-assessment using patient diary; the diary may be recorded by someone on behalf of the patient, on the condition that the patient is able to perform the assessment unaided. (7) Cancer patients whose condition is expected to be stable during the observation period (8) Patients who give written informed consent for participation in the study upon being informed about this study

Exclusion criteria

Exclusion criteria: (1) Patients who serious structural abnormalities of the gastrointestinal tract (e.g., mechanical ileus), diseases that affect bowel transit (e.g., (2) Patients who underwent surgery, intervention (e.g., nerve block), or radiation therapy that affects the digestive function within 28 days of the day of registration, or those who are scheduled to undergo such procedures during the observation period (3) Patients who had two or fewer bowel movements during the 7-day period immediately prior to the day of patient registration (4) Patients who had disimpaction within the 7-day period immediately before the day of registration, or are scheduled to undergo the procedure during the observation period (5) Patients with artificial anus (6) Patients who are consideredineligiblethe study by the physician based on concomitant therapies or medical findings

Design outcomes

Primary

Measure	Time frame
Morbidity of OIC based on ROME IV diagnostic criteria	—

Countries

Japan

Contacts

Public ContactSatomi Nakano

EP-CRSU Japane Co., Ltd. Clinical Research Headquarters

prj-oicj-office@eps.co.jp06-6202-5375

Outcome results