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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date July 6, 2023
First Posted Date July 27, 2023
Last Update Posted Date July 27, 2023
Actual Study Start Date June 1, 2023
Estimated Primary Completion Date May 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 24, 2023)
  • 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).
  • 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: July 24, 2023)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Real World Study of Oxycodone Sustained-release Tablets for Patients With Moderate to Severe Cancer Pain
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
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.
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 Type Observational
Study Design Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Cancer Pain
  • Real-world Study
  • Oxycodone
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 24, 2023)		 916
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 31, 2024
Estimated Primary Completion Date May 31, 2024   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Suxia Luo, Doctor +86 18638553211 luosxrm@163.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT05962294
Other Study ID Numbers TA2023-246
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Henan Cancer Hospital
Original Responsible Party Same as current
Current Study Sponsor Henan Cancer Hospital
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Henan Cancer Hospital
Verification Date July 2023