PainPhase 1/2NCT03016364
Application Software in Dosage Adjustment for Advanced Cancer Patients With Pain
A Phase 1/2 study testing APP software in people with Pain and Physicians, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pain, Physicians, Oxycodone
- What is being tested?
- APP software
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jan 2017to Dec 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- allergic to Oxycodone Hydrochloride Prolonged-release Tablets, or other reasons (determined by clinical doctors) unable to use the Opioids
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Peng Liu, MD, 8610-87788507, 13910216310@163.com
About this study
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.
- Conditions
- Pain, Physicians, Oxycodone
- Being tested
- APP software
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: APP software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Pain Rating Scale
Measured: upto 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peng Liu, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03016364
- Sponsor's protocol ID
- CFH2016-3-4025
- Status last verified
- Jan 2019
- First submitted
- 9 Jan 2017
- Last updated
- 23 Jan 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application Software in Dosage Adjustment for Advanced Cancer Patients With Pain
- ClinicalTrials.gov ID
- NCT03016364
- Acronym / sponsor ID
- CFH2016-3-4025
- Conditions
- Pain, Physicians, Oxycodone
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 10 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| APP in dosage adjustment | Experimental | Device: APP softwareThrough 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- allergic to Oxycodone Hydrochloride Prolonged-release Tablets, or other reasons (determined by clinical doctors) unable to use the Opioids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APP softwareA software used to by physicians to adjust the dose of Oxycodone Hydrochloride Prolonged-release Tablets for advanced patient's with cancer pain | Device | APP in dosage adjustment |
Primary outcome
Numerical Pain Rating Scale
Time frame: upto 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing APP software in people with Pain and Physicians, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peng Liu, MD (8610-87788405, 13910216310@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Pain Rating Scale (time frame: upto 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2019.