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NCT04296305 · ClinicalTrials.gov registry record · Phase 4

Effect of Opioid Infusion Rate on Abuse Liability Potential of Intravenous Hydromorphone for Cancer Pain

A Phase 4 study of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm, sponsored by M.D. Anderson Cancer Center.

Active
Registry status
Phase 4
Development phase
84
Enrollment target
1
Study location

NCT04296305 is a Phase 4 study of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 84 participants, below the 1,140-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04296305, a Phase 4 study of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.

ACTIVE NOT RECRUITING
Registry status
Phase 4
Development phase
84 participants
Enrollment target
1
Study location

Study Summary

In cancer inpatient settings, intravenous (IV) opioids are frequently administered in a bolus fashion in order to obtain immediate pain relief. However, data on the abuse liability (AL) potential of IV opioids in cancer patients is limited. No study has investigated the effect of different IV infusion rates on AL potential in patients receiving parenteral opioids for pain control. This phase IV trial will determine the AL potential of a slow IV hydromorphone (SH) bolus administration compared with a fast IV hydromorphone (FH) bolus administration among inpatients with cancer pain. It will also determine the analgesic efficacy and adverse effect profiles of SH versus FH bolus infusions, and explore the relationship between pharmacogenetics and pharmacokinetic (PK) and pharmacodynamic (PD) effects of hydromorphone. This study will eventually help develop evidence-based guidelines regarding the best style of IV opioid administration which will achieve the most optimal pain control while avoiding the undesirable complication of nonmedical opioid use

Interventions

  • OTHER Questionnaire Administration
  • DRUG Placebo Administration
  • DRUG Hydromorphone

Study Locations (1)

Texas

  • M D Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 84 participants
Start Date 2020-09-10
Est. Completion 2027-12-31
Phase Phase 4

Sponsor

M.D. Anderson Cancer Center

2,692 total trials

What the Registry Record Tells You About NCT04296305

The ClinicalTrials.gov registry entry for NCT04296305 describes a study currently listed as active not recruiting, categorized as Phase 4. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,140-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (93% lower). The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Malignant Solid Neoplasm appearing as the primary indexed condition, and to 3 interventions - of which Questionnaire Administration is the first listed.

NCT04296305 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT04296305 about?

NCT04296305 is a clinical study titled "Effect of Opioid Infusion Rate on Abuse Liability Potential of Intravenous Hydromorphone for Cancer Pain". In cancer inpatient settings, intravenous (IV) opioids are frequently administered in a bolus fashion in order to obtain immediate pain relief. However, data on the abuse liability (AL) potential of IV opioids in cancer patients is limited. No study has investigated the effect of different IV infusi...

What is the current status of trial NCT04296305?

This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 84 participants. The study started on 2020-09-10. Estimated completion is 2027-12-31.

What conditions does trial NCT04296305 study?

This clinical trial studies the following conditions: Malignant Solid Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm.

What interventions are being tested in trial NCT04296305?

The interventions under investigation include: Questionnaire Administration (OTHER), Placebo Administration (DRUG), Hydromorphone (DRUG).

Who is sponsoring clinical trial NCT04296305?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04296305 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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