Real World Study of Oxycodone Sustained-release Tablets for Patients With Moderate to Severe Cancer Pain

NCT05962294 | Unknown DMC

• 1 other identifier: TA2023-246
• Study Type: observational
• Target: 916
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this real world study is to observe the efficacy and safety of Oxycodone Hydrochloride Sustained-release Tablets in the treatment of moderate to severe cancer pain participants in real clinical practice. After entering the study, participants will take Oxycodone Hydrochloride Sustained-release Tablets. The investigators need to observe and record relevant data, and finally analyze and summarize the data to understand the efficacy and safety.

Conditions

Cancer Pain; Real-world Study; Oxycodone

Keywords

Oxycodone Hydrochloride Sustained-release Tablets

Outcome Measures

Primary Outcomes (2)

• Mean difference in pain intensity after treatment

  Use the Numeric Rating Scale（NRS, 0 to 10 points, lower scores indicate better pain control） to evaluate the average pain score per day over the past 24 hours. Calculate the daily difference in pain intensity (PID) by subtracting the daily NRS score from the baseline NRS score. Divide the sum of PID on days 1 to 14 by 14 to obtain the mean difference in pain intensity (MPID).

  From the 1st to 14th day of treatment

• The proportion of patients with effective pain relief

  Effective pain relief is defined as a decrease of 30% or more in average pain intensity from day 1 to day 14 compared to the baseline period.

  From the 1st to 14th day of treatment

Secondary Outcomes (4)

• The proportion of patients with effective pain control

  From the 1st to 14th day of treatment

• The time for the patient's pain to be effectively controlled

  From the 1st to 14th day of treatment

• The improvement of patient symptoms

  On the 3rd, 7th, and 14th days after treatment

• The satisfaction with pain control

  On the 3rd, 7th, and 14th days after treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study is a prospective, single arm, multicenter real-world study that only needs to meet the requirements of age, disease type, drug dosage, and no severe mental illness in the study population

You may qualify if:

• Voluntarily sign an informed consent form;
• Age ≥ 18 years old;
• Patients with moderate to severe (NRS ≥ 4 points) cancer pain;
• Patients with oral equivalent Oxycodone Hydrochloride Sustained-release Tablets ≥ 80mg/d.

You may not qualify if:

• \. Patients with severe mental illness who cannot cooperate with follow-up

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

RECRUITING

MeSH Terms

Conditions

Cancer Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Suxia Luo, Doctor

CONTACT

+86 18638553211; luosxrm@163.com

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 27, 2023
• Study Start: June 1, 2023
• Primary Completion: May 31, 2024
• Study Completion: July 31, 2024
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

CN (1)