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

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ClinicalTrials.gov Identifier: NCT05962294
Recruitment Status : Recruiting
First Posted : July 27, 2023
Last Update Posted : July 27, 2023
Sponsor:
Information provided by (Responsible Party):
Henan Cancer Hospital

Study Description
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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.


Condition or disease
Cancer Pain Real-world Study Oxycodone

Detailed Description:
This study is a prospective, single arm, multicenter real world study, the investigators didn't set up a control group. After the participant is enrolled, the participant will enter a 14 day treatment cycle, where the medication will be proportionally converted into Oxycodone Hydrochloride Sustained-release Tablets. The daily medication dose will be adjusted based on the number of pain outbreaks and pain scores (According to the drug increment principle of NCCN), and various information (Daily oxycodone dose, average pain score, minimal pain score, most severe pain score, number of breakout pain, name of rescue drugs, number of rescue, heart rate, blood pressure, respiratory rate, SPO2, combination of drugs, pain control satisfaction, etc) about the participant's medication will be recorded. The participant will not be limited to whether to combine medication. Observe the efficacy and safety of Oxycodone Hydrochloride Sustained-release Tablets.
Study Design
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Study Type : Observational
Estimated Enrollment : 916 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: The Efficacy and Safety of Oxycodone Hydrochloride Sustained-release Tablets in the Treatment of Moderate to Severe Cancer Pain：A Multicenter Real World Study
Actual Study Start Date : June 1, 2023
Estimated Primary Completion Date : May 31, 2024
Estimated Study Completion Date : July 31, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Mean difference in pain intensity after treatment [ Time Frame: From the 1st to 14th day of 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).

  2. The proportion of patients with effective pain relief [ Time Frame: From the 1st to 14th day of treatment ]
    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.


Secondary Outcome Measures :
  1. The proportion of patients with effective pain control [ Time Frame: From the 1st to 14th day of treatment ]
    The proportion of patients whose pain is under control. It requires the Numeric Rating Scale (NRS, 0 to 10 points, lower scores indicate better pain control) is ≤ 3 points, and the break-through cancer pain is ≤ 3 times per day.

  2. The time for the patient's pain to be effectively controlled [ Time Frame: From the 1st to 14th day of treatment ]
    The time from the beginning of treatment to effective pain control for patients. It requires the Numeric Rating Scale (NRS, 0 to 10 points, lower scores indicate better pain control) is ≤ 3 points, and the break-through cancer pain is ≤ 3 times per day.

  3. The improvement of patient symptoms [ Time Frame: On the 3rd, 7th, and 14th days after treatment ]
    We use the Brief Pain Inventory (BPI) to evaluate the improvement of patient symptoms. There are a total of 7 projects, with each project scoring 0-10 points. The lower the score, the more significant the improvement in symptoms.

  4. The satisfaction with pain control [ Time Frame: On the 3rd, 7th, and 14th days after treatment ]
    0-10 points (the higher the score, the higher the satisfaction), participants can rate treatment satisfaction based on the efficacy and safety of the experimental drug. It's the patient's subjective perception of pain control.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05962294


Contacts
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Contact: Suxia Luo, Doctor +86 18638553211 luosxrm@163.com

Locations
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China, Henan
Henan Cancer Hospital Recruiting
Zhengzhou, Henan, China, 450003
Contact: Suxia Luo, Doctor    +8618638553211    luosxrm@163.com   
Sponsors and Collaborators
Henan Cancer Hospital
More Information
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Responsible Party: Henan Cancer Hospital
ClinicalTrials.gov Identifier: NCT05962294    
Other Study ID Numbers: TA2023-246
First Posted: July 27, 2023    Key Record Dates
Last Update Posted: July 27, 2023
Last Verified: July 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Henan Cancer Hospital:
Oxycodone Hydrochloride Sustained-release Tablets
Additional relevant MeSH terms:
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Cancer Pain
Pain
Neurologic Manifestations