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Opioid Analgesic
Hydromorphone Infusion Rates for Cancer Pain
Phase 4
Waitlist Available
Led By Joseph A Arthur
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Hospitalized patients with diagnosis of cancer
History of moderate to severe cancer related pain, defined as Numerical Rating Scale (NRS) pain score >= 4/10
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline up to 120 minutes post intervention
Awards & highlights
Study Summary
This trial will compare the abuse liability of slow versus fast intravenous hydromorphone administration in cancer patients. It will also determine the analgesic efficacy and adverse effect profiles of the two styles of administration, and explore the relationship between pharmacogenetics and the effects of hydromorphone.
Who is the study for?
This trial is for hospitalized cancer patients with moderate to severe pain who haven't been using opioids regularly. They must be able to understand and speak English, give consent, and have normal cognitive function without confusion or memory issues. People can't join if they misuse opioids, have liver or kidney problems, allergies to opioids, unstable vital signs like high heart rate or low oxygen levels.Check my eligibility
What is being tested?
The study tests how the speed of giving hydromorphone (an opioid) through an IV affects its potential for abuse in controlling cancer pain. It compares slow versus fast infusion rates of hydromorphone while also looking at pain relief effectiveness and side effects related to different genetic responses.See study design
What are the potential side effects?
Possible side effects include typical opioid-related reactions such as nausea, vomiting, constipation, drowsiness, itching or rash. There's also a risk of slower breathing rate which is more serious and requires immediate medical attention.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am currently hospitalized and have been diagnosed with cancer.
Select...
I experience significant cancer-related pain, rated 4 or higher on a scale of 10.
Select...
I am not taking opioids or only take them when absolutely necessary.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline up to 120 minutes post-intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline up to 120 minutes post-intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Abuse liability potential of SH bolus versus FH bolus (from the "DRUG LIKING" scale of the DEQ questionnaire)
Secondary outcome measures
Abuse liability potential among patients who achieved successful analgesia
Abuse liability potentials of SH bolus versus FH bolus (from the other scales of the DEQ questionnaire)
Adverse effect
+6 moreSide effects data
From 2015 Phase 4 trial • 84 Patients • NCT0200972252%
Moderate to Severe Pruritus
40%
Moderate to Severe Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Intrathecal Morphine
Intrathecal Hydromorphone
Trial Design
2Treatment groups
Experimental Treatment
Group I: Group B (hydromorphone, placebo)Experimental Treatment3 Interventions
TREATMENT PHASE I: Patients receive hydromorphone IV over 15 minutes and placebo IV over 2 minutes.
TREATMENT PHASE II: Patients receive hydromorphone IV over 2 minutes and placebo IV over 15 minutes.
Group II: Group A (hydromorphone, placebo)Experimental Treatment3 Interventions
TREATMENT PHASE I: Patients receive hydromorphone IV over 2 minutes and placebo IV over 15 minutes.
TREATMENT PHASE II: Patients receive hydromorphone IV over 15 minutes and placebo IV over 2 minutes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hydromorphone
2005
Completed Phase 4
~4340
Placebo Administration
2018
Completed Phase 3
~2540
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,718 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,583 Total Patients Enrolled
1 Trials studying Blood Cancers
70 Patients Enrolled for Blood Cancers
Joseph A ArthurPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
207 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently hospitalized and have been diagnosed with cancer.I cannot take opioids due to allergies or other reasons.Your heart rate is more than 120 beats per minute when you are not doing any physical activity.You have a history of using opioids for nonmedical reasons, such as for abusing or misusing them.My kidney function is reduced with a GFR less than 60 ml/min.I have been on opioid pain medication for more than a week.My liver tests are not more than 3 times the normal limit.Your blood pressure is too high (above 180/90) or too low (above 100/60) when first checked.You don't have any noticeable problems with memory, concentration, or confusion.I experience significant cancer-related pain, rated 4 or higher on a scale of 10.I cannot have an IV inserted.I am not taking opioids or only take them when absolutely necessary.Your blood oxygen level is less than 92% or your breathing rate is less than 12 breaths per minute when first checked.
Research Study Groups:
This trial has the following groups:- Group 1: Group A (hydromorphone, placebo)
- Group 2: Group B (hydromorphone, placebo)
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research program still recruiting participants?
"No longer recruiting, this clinical trial was first posted on September 10th 2020 and last updated on July 13th 2022. As an alternative option, there are 2457 studies actively searching for participants with lymphoid cells in addition to 15 trials for Hydromorphone that are currently enrolling patients."
Answered by AI
Has Hydromorphone been explored in other experimental research initiatives?
"Currently, 15 clinical trials are being conducted to investigate Hydromorphone. Three of these investigations have progressed to the third and final phase while multiple sites across Fuzhou, Fujian have been involved in patient recruitment for this medication."
Answered by AI
Has the FDA sanctioned Hydromorphone for medical use?
"There is already a considerable body of evidence confirming hydromorphone's safety, so it received the maximum score of 3."
Answered by AI
How many individuals have enrolled in this clinical experiment?
"Unfortunately, the trial is not active at this time. The study was initially posted on September 10th 2020 and last revised on July 13th 2022. Should you be interested in other trials, there are 2457 studies utilizing lymphoid cells actively recruiting patients and 15 clinical trials requiring participants to take hydromorphone."
Answered by AI
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