Application Software in Dosage Adjustment for Advanced Cancer Patients With Pain

January 21, 2019 updated by: Peng Liu, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
The purpose of this trial is to determine whether Application (APP) would help clinical doctors to adjust the dose of Oxycodone Hydrochloride Prolonged-release Tablets in advanced patients with cancer pain.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100021
        • Recruiting
        • Cancer Hospital, Chinese Academy of Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • a histologically confirmed diagnosis of Cancer or Sarcoma
  • advanced patients with severe cancer pain(score >3)
  • having used or expected to use the Oxycodone Hydrochloride Prolonged-release Tablets

Exclusion Criteria:

  • allergic to Oxycodone Hydrochloride Prolonged-release Tablets, or other reasons (determined by clinical doctors) unable to use the Opioids

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: APP in dosage adjustment
Through the guidance of APP software, clinical doctors try to adjust the dose of Oxycodone Hydrochloride Prolonged-release Tablets for advanced patient's with cancer pain.
Device: APP software
A software used to by physicians to adjust the dose of Oxycodone Hydrochloride Prolonged-release Tablets for advanced patient's with cancer pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Numerical Pain Rating Scale
Time Frame: upto 8 months
upto 8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

January 9, 2017

First Submitted That Met QC Criteria

January 9, 2017

First Posted (Estimate)

January 10, 2017

Study Record Updates

Last Update Posted (Actual)

January 23, 2019

Last Update Submitted That Met QC Criteria

January 21, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • CFH2016-3-4025

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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