Observational study on opioid-induced constipation in patients with non-cancer chronic pain using weak opioid analgesics in Japan

Observational study on opioid-induced constipation in patients with non-cancer chronic pain using weak opioid analgesics in Japan - Observational study on opioid-induced constipation in patients with non-cancer chronic pain using weak opioid analgesics in Japan

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000050203

Enrollment

Registered

2023-02-01

Start date

2023-02-01

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) Patients 18 years of age or older with chronic musculoskeletal pain 2) Patients newly prescribed weak opioid analgesics and plan to take them for over 2 weeks 3) Patients before or within 1 day of starting weak opioid analgesics 4) Patients with more than 3 spontaneous bowel movements in a week before 5) Patients who can download the application and answer the web questionnaire by using mobile devices (smart phone, tablet etc.) 6) Patients who have given their consent to participate in this study

Exclusion criteria

Exclusion criteria: 1) Patients with a history of treated with opioids within the past 4 weeks 2) Hospitalized patients 3) Patients with malignant tumors 4) Patients with two or more of the following constipation symptoms in the past week prior to starting weak opioid analgesics a. Straining during more than 1/4 (25%) of defecations b. Lumpy or hard stools (Bristol Stool Form Scale 1-2) during more than 1/4 (25%) of defecations c. Sensation of incomplete evacuation during more than 1/4 (25%) of defecations d. Sensation of anorectal obstruction/blockage during more than 1/4 (25%) of defecations e. Manual maneuvers to facilitate more than 1/4 (25%) of defecations (e.g., digital evacuation, support of the pelvic floor) f. Fewer than three SBM (spontaneous bowel movement) per week

Design outcomes

Primary

Measure	Time frame
Incidence of OIC in 2 weeks after starting weak opioid analgesics (ROME-IV diagnostic criteria)	—

Secondary

Measure	Time frame
The following outcomes in 2 weeks after starting weak opioid analgesics - Incidence of OIC (per day, per week) - Incidence of symptoms of OIC - Proportion of patients who consider themselves to be constipated - PAC-SYM score - SF-36 v2 acute score - NRS score - Proportion of patients who take laxatives	—

Countries

Japan

Contacts

Public ContactYasuhide Morioka

Shionogi & Co., Ltd. Medical Affairs Department

yasuhide.morioka@shionogi.co.jp070-7812-6306

Outcome results