A Phase 4 interventional study of Ondansetron and Placebo Comparator in Pruritus and Nausea/Vomiting, sponsored by University of Michigan. Terminated at 1 site in United States. Open to participants aged 3 Years to 17 Years. Per ClinicalTrials.gov, last updated 2021-01-19.
Sponsored by University of Michigan · Phase 4, Interventional, and Prevention
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Among 163 studies in Pruritus with a site in United States — 24 open to participants now, 28 under way, 8 of them phase 3. Pruritus · United States.
Among the 163 studies in Pruritus with a site in United States, this one is the 101st largest by enrollment of the 153 interventional ones that give a count, is one of 11 that started in 2017, is one of 13 in phase 4, and was the 65th registered.
491 studies on the registry are indexed under Pruritus; 94 are open to participants now.
Browse Pruritus studies →24 of the 163 studies in Pruritus with a site in United States are open now. Recruiting first, the newest first:
Arcutis Biotherapeutics, Inc. · Sites in United States
Ages 6+
Novartis Pharmaceuticals · Sites in United States, Canada, China
Ages 18+
Novartis Pharmaceuticals · Sites in United States, Argentina, Canada and 2 more countries
Ages 18+
Paradigm Therapeutics · Sites in United States
Ages 28 days–12 yrs
Integrative Skin Science and Research · Sites in United States
Ages 12+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 54 Pruritus studies recruiting now, 22 (41%) set no upper age limit and 24 (44%) stop at 75 or younger; 15 take children under 18; 10 take healthy volunteers.
This study: 3 Years to 17 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
163 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 14 · Phase 2 69 · Phase 3 48 · Phase 4 13
First in 2000; this study’s year is marked. 11 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 46 is below the median of 60 across 423 interventional studies indexed under Pruritus.
Median enrollment 70 across the 153 interventional studies, 80 across the 9 observational. Of the 126 that completed or were terminated, 80 (63%) have results posted.
This tab as a report to print or save as PDF → With an account.
108 of 163 have an industry lead sponsor. The 10 most frequent:
University of Michigan is the lead sponsor of 1,507 studies on the registry; 193 are open to participants now.
Of its 169 completed or terminated interventional studies of FDA-regulated products, 133 (79%) have results posted.
University of Michigan has 1 study filed under Pruritus — fewer than ten, so there is no comparison to draw.
12 of the studies in Pruritus with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07482787Phase 3Paradigm TherapeuticsEfficacy and Safety Study to Evaluate SD-101 in Epidermolysis Bullosa | 2027-05-17 |
| NCT05263206Phase 3SanofiEfficacy and Safety of Subcutaneous Dupilumab for the Treatment of Adult Participants With Chronic Pruritus of Unknown Origin (CPUO) (LIBERTY-CPUO-CHIC) | 2027-06-02 |
| NCT07450716Massachusetts General HospitalAssessing the Efficacy and Safety of Photobiomodulation for the Treatment of Pruritus | 2026-12 |
| NCT07317271Johns Hopkins UniversityVR-PMR for Post-Burn Symptoms | 2026-12 |
| NCT07074977Galderma R&DProof of Concept Study to Assess the Pharmacokinetics/Pharmacodynamics of Nemolizumab in Adults With Chronic Pruritus of Unknown Origin (CPUO) | 2026-12 |
Add all 12 to your calendar (.ics) → With an account.
Among the 163 studies in Pruritus with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a prospective randomized, double-blind, placebo-controlled study to compare the incidence and intensity of ITM-induced pruritus and nausea/vomiting using pre-emptive IV ondansetron, followed by scheduled Around The Clock (ATC) ondansetron vs. our control group, where pruritus and PONV are treated with PRN only medications.
Pruritus is one of the most common and bothersome side effects of intrathecal morphine (ITM) in children, with a reported incidence of 30-60%. Clinicians, who have witnessed unbearable itching and scratching in their young patients after intrathecal morphine, may be reluctant to offer this effective pain control to future patients, for fear of these unpleasant sequelae. A study previously found a 40% incidence of pruritus in young children who received intrathecal morphine for major urologic surgery.
This is a prospective randomized, double-blind, placebo-controlled study to compare the incidence and intensity of ITM-induced pruritus and nausea/vomiting using pre-emptive IV ondansetron, followed by scheduled Around The Clock (ATC) ondansetron vs. control group, where pruritus and PONV are treated with PRN only medications.
Enrollment of 3-17 year olds who are undergoing urologic or orthopedic operative procedures who are scheduled to receive low dose (4-5 mcg/kg) intrathecal morphine for pain management.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ondansetron IV X1 intraoperatively (0.1 mg/kg in 5 mLs) Ondansetron IV X 4 (Q 6 hrs for 24 hrs) (0.1 mg/kg in 5 mLs)
Drug: Ondansetron
Placebo Comparator: This arm will receive (in a blinded fashion) a volume-matched placebo intraoperatively X1 as well as IV every 6 hrs for 24 hours postoperatively. (X4)
Drug: Placebo Comparator
This arm will receive (in a blinded fashion) 0.1 mg/kg of Ondansetron IV made up to 5 mLs intra-operatively and Ondansetron IV 0.1 mg/kg made up to 5 mLs every 6 hours for 24 hours postoperatively.
This arm will receive (in a blinded fashion) a volume-matched placebo intraoperatively as well as IV every 6 hrs for 24 hours postoperatively.
Incidence of Pruritus
number of participants with any incidence of pruritus
Time frame: 24 hours
Severity of Pruritus
number of participants who indicated mild pruritus (no treatment needed) or severe pruritus (treatment needed)
Time frame: 24 hours
Incidence of Post Operative Nausea or Vomiting
number of participants with any incidence of postoperative nausea or vomiting
Time frame: 24 hours
Severity of Post Operative Nausea or Vomiting
number of participants who Indicated mild post operative nausea or vomiting (no treatment needed) or severe postoperative nausea or vomiting(treatment needed)
Time frame: 24 hours
| Milestone | Ondansetron IV | Placebo |
|---|---|---|
| Started | 18 | 28 |
| Completed | 18 | 27 |
| Not completed | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
number of participants with any incidence of pruritus
| Participants | Ondansetron IV | Placebo |
|---|---|---|
| Incidence of Pruritus | 14 | 24 |
number of participants who indicated mild pruritus (no treatment needed) or severe pruritus (treatment needed)
| Participants | Ondansetron IV | Placebo |
|---|---|---|
| Mild / no treatment needed | 1 | 4 |
| Severe / requiring treatment | 13 | 20 |
number of participants with any incidence of postoperative nausea or vomiting
| Participants | Ondansetron IV | Placebo |
|---|---|---|
| Incidence of Post Operative Nausea or Vomiting | 8 | 23 |
number of participants who Indicated mild post operative nausea or vomiting (no treatment needed) or severe postoperative nausea or vomiting(treatment needed)
| Participants | Ondansetron IV | Placebo |
|---|---|---|
| Mild / no treatment required | 2 | 4 |
| Severe / requiring treatment | 6 | 19 |
Collected over Adverse events were tracked through hospital discharge (approximately 24 hours). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ondansetron IV | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| Placebo | 0/27 (0%) | 0/27 (0%) | 0/27 (0%) |
| Age, Customized(years) | Ondansetron IV | Placebo | Total |
|---|---|---|---|
| Mean | 8.3 (3.5 to 17.1) | 8.2 (3.7 to 16.7) | 8.3 (3.5 to 17.1) |
| Sex: Female, Male(Participants) | Ondansetron IV | Placebo | Total |
|---|---|---|---|
| Female | 12 | 17 | 29 |
| Male | 6 | 10 | 16 |
| Race and Ethnicity Not Collected(Participants) | Ondansetron IV | Placebo | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Weight(kg) | Ondansetron IV | Placebo | Total |
|---|---|---|---|
| Mean | 30.4 (16.4 to 64.8) | 34.0 (14.5 to 91.4) | 32.5 (14.5 to 91.4) |
| ASA 1, 2(Participants) | Ondansetron IV | Placebo | Total |
|---|---|---|---|
| Count of participants | 15 | 27 | 42 |
| Surgical Service(Participants) | Ondansetron IV | Placebo | Total |
|---|---|---|---|
| Urology | 14 | 22 | 36 |
| Orthopedics | 4 | 5 | 9 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2017 to primary completion in Aug 2019, 20 months.
Results were first posted in Jan 2021, 1 year 4 months after primary completion. A results delay was requested in Aug 2020.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ondansetron