NCT03016364

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_1 pain

Timeline
Completed

Started Jan 2017

Longer than P75 for phase_1 pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 10, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

January 23, 2019

Status Verified

January 1, 2019

Enrollment Period

2.9 years

First QC Date

January 9, 2017

Last Update Submit

January 21, 2019

Conditions

PainPhysiciansOxycodone

Outcome Measures

Primary Outcomes (1)

  • Numerical Pain Rating Scale

    upto 8 months

Study Arms (1)

APP in dosage adjustment

EXPERIMENTAL

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

Interventions

APP softwareDEVICE

A software used to by physicians to adjust the dose of Oxycodone Hydrochloride Prolonged-release Tablets for advanced patient's with cancer pain

APP in dosage adjustment

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Peng Liu, MD

CONTACT

8610-8778840513910216310@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

January 9, 2017

First Posted

January 10, 2017

Study Start

January 1, 2017

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

January 23, 2019

Record last verified: 2019-01

Locations

CN(1)