An Exploratory Observational Study on the Prescription Patterens for the Treatment of Gastrointestinal Adverse Events Following the Prescription of Mild Opioid Analgesics in Non-Cancer Pain Patients

An Exploratory Observational Study on the Prescription Patterens for the Treatment of Gastrointestinal Adverse Events Following the Prescription of Mild Opioid Analgesics in Non-Cancer Pain Patients - An Exploratory Observational Study on the Prescription Patterens for the Treatment of Gastrointestinal Adverse Events Following the Prescription of Mild Opioid Analgesics in Non-Cancer Pain Patients

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000059932

Enrollment

2000

Registered

2025-12-05

Start date

2025-05-31

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 who were prescribed weak opioid analgesics (tramadol hydrochloride, tramadol-acetaminophen combination, codeine, Buprenorphine) for non-cancer pain from April 2017 to March 2024. 2.Patients who had a visit after week 13 following the initial prescription of weak opioid analgesics Patients with all of the following data -Patient demographics (age, gender, underlying condition causing pain) -Prescription information of weak opioid analgesics (prescription date, drug name, prescribed dosage (/day))

Exclusion criteria

Exclusion criteria: 1.Patients who have declined participation in this study (opt-out method) 2.Patients with opioid analgesics up to 4 weeks before starting weak opioid analgesics 3.Patients who have a diagnosis of cancer (excluding carcinoma in situ) at the time of starting weak opioid analgesics

Design outcomes

Primary

Measure	Time frame
1. Patient Background 2. Proportion of patients who had addition, dose escalation, or change in constipation medication 3. Proportion of patients who had addition of constipation medication 4. Proportion of patients who had dose escalation of constipation medication 5. Proportion of patients who had change in constipation medication 6. Proportion of patients who had dose reduction or discontinuation of constipation medication 7. Duration from initiation of weak opioid analgesics to achieving optimal regimen of prescribed constipation medication 8. Proportion of patients who were prescribed antiemetic medication 9. Prescribed quantity of weak opioid analgesics (mean, median) 10.Change in quantity of weak opioid analgesics from the start of prescription until the end of the observation Period 11.Types and details of constipation medications added or changed 12.Period Between Initiation of Weak Opioid Analgesics and Addition or Change of Prescribed Constipation Medication	—

Measure

Time frame

1. Patient Background 2. Proportion of patients who had addition, dose escalation, or change in constipation medication 3. Proportion of patients who had addition of constipation medication 4. Proportion of patients who had dose escalation of constipation medication 5. Proportion of patients who had change in constipation medication 6. Proportion of patients who had dose reduction or discontinuation of constipation medication 7. Duration from initiation of weak opioid analgesics to achieving optimal regimen of prescribed constipation medication 8. Proportion of patients who were prescribed antiemetic medication 9. Prescribed quantity of weak opioid analgesics (mean, median) 10.Change in quantity of weak opioid analgesics from the start of prescription until the end of the observation Period 11.Types and details of constipation medications added or changed 12.Period Between Initiation of Weak Opioid Analgesics and Addition or Change of Prescribed Constipation Medication

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Countries

Japan

Contacts

Public ContactShihomi Wada

Shionogi & Co., Ltd. Medical Affairs

shihomi.wada@shionogi.co.jp080-2525-9360

Outcome results