A Phase 4 interventional study of Ondansetron 4 MG and Ondansetron 8mg in Post-operative Nausea and Vomiting, sponsored by Icahn School of Medicine at Mount Sinai. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-20.
Sponsored by Icahn School of Medicine at Mount Sinai · Phase 4, Interventional, and Prevention
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Among 59 studies testing ondansetron in Vomiting — 3 open to participants now, 3 under way, none of them phase 3. Ondansetron · Vomiting.
Among the 59 studies testing ondansetron in Vomiting, this one is the 21st largest by enrollment of the 58 interventional ones that give a count, is one of 5 that started in 2017, is one of 15 in phase 4, and was the 46th registered.
793 studies on the registry are indexed under Vomiting; 99 are open to participants now.
Browse Vomiting studies →3 of the 59 studies testing ondansetron in Vomiting are open now, in 3 countries. Recruiting first, the newest first:
Sanliurfa Education and Research Hospital · Sites in Turkey
Ages 18+ · Women only
University of Illinois Chicago · Sites in United States
Ages 18–75
Public Interest Science Center · Sites in Republic of the Congo
Ages 6 mo–17 yrs
By country, each count listing its studies:
Ondansetron: first FDA approval 1991 (ZOFRAN). What it is approved for, and how studies give it, is on its page →
Of the 56 Vomiting studies recruiting now, 26 (46%) set no upper age limit and 24 (43%) stop at 75 or younger; 10 take children under 18; 17 take healthy volunteers.
This study: 18 Years and older · 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.
59 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 5 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 141 is above the median of 103 across 673 interventional studies indexed under Vomiting.
Median enrollment 103 across the 58 interventional studies. Of the 49 that completed or were terminated, 17 (35%) have results posted.
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11 of 59 have an industry lead sponsor. The 10 most frequent:
Icahn School of Medicine at Mount Sinai is the lead sponsor of 776 studies on the registry; 176 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 83 (66%) have results posted.
Icahn School of Medicine at Mount Sinai has 1 study filed under Vomiting — fewer than ten, so there is no comparison to draw.
3 of the studies testing ondansetron in Vomiting that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07740577Sanliurfa Education and Research HospitalRoutine Antiemetic Prophylaxis for Nonfasted Parturients Undergoing Cesarean Sections Under Spinal Anesthesia | 2027-01-01 |
| NCT04150614University of Illinois ChicagoBMT-08: A Comparative Effectiveness Study of Transdermal Granisetron to Ondansetron | 2027-03 |
| NCT07795060Public Interest Science CenterOndansetron to Prevent Oral Rehydration Failure in Children With Cholera | 2027-08-31 |
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Among the 59 studies testing ondansetron in Vomiting, from their registry updates:
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The aim is to evaluate the effectiveness of three different regimens of prophylactic ondansetron on the incidence and severity of post-operative nausea and vomiting.
Patients will be randomize to one of three arms: 4mg ondansetron pre-emergence, 8 mg ondansetron pre-emergence, or 4mg ondansetron pre-incision followed by 4mg ondansetron pre-emergence. Primary outcome will be incidence of PONV in the PACU prior to discharge.
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.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Ondansetron 4 MG
Drug: Ondansetron 8mg
4mg Ondansetron Pre-Incision and 4mg Ondansetron Pre-emergence
Drug: Ondansetron 4 MG
dose as per arm selection
dose as per arm selection
Nausea Scale
Nausea Scale - full scale from 1-10, with higher score indicating more symptom of nausea
Time frame: average of 4 hours in PACU and POD1
Number of Participants With Episodes of Vomiting in the PACU
Number of participants with episodes of vomiting in the Post Anesthesia Care Unit
Time frame: average of 4 hours
Number of Participants With Symptoms on POD 1
Number of participants with symptom presence of nausea or vomiting or headache on post-operative day one
Time frame: Day 1
Number of Participants Who Needed Rescue Anti-emetics
Number participants who needed rescue anti-emetics, i.e,, additional treatments needed to control nausea or vomiting in the PACU
Time frame: average of 4 hours
Total Anesthesia Time
Time frame: intraoperative, up to 3.5 hours
165 patients assessed for eligibility 141 patients were randomized
| Milestone | Ondansetron 4mg Pre-emergence | Ondansetron 8mg Pre-emergence | Ondansetron Pre-Incision and Pre-emergence |
|---|---|---|---|
| Started | 48 | 46 | 47 |
| Completed | 43 | 42 | 43 |
| Not completed | 5 | 4 | 4 |
| Withdrew: Incomplete/illegible data sheet | 4 | 2 | 3 |
| Withdrew: Missing post-op data | 1 | 2 | 1 |
Nausea Scale - full scale from 1-10, with higher score indicating more symptom of nausea
| score on a scale | Ondansetron 4mg Pre-emergence | Ondansetron 8mg Pre-emergence | Ondansetron Pre-Incision and Pre-emergence |
|---|---|---|---|
| PACU | 3.5 (1.75 to 4.0) | 4.0 (3.0 to 6.0) | 4.0 (1.5 to 6.0) |
| POD1 | 2.0 (1.0 to 3.0) | 1.0 (1.0 to 5.5) | 8.0 (8.0 to 8.0) |
Number of participants with episodes of vomiting in the Post Anesthesia Care Unit
| Participants | Ondansetron 4mg Pre-emergence | Ondansetron 8mg Pre-emergence | Ondansetron Pre-Incision and Pre-emergence |
|---|---|---|---|
| Number of Participants With Episodes of Vomiting in the PACU | 2 | 0 | 1 |
Number of participants with symptom presence of nausea or vomiting or headache on post-operative day one
| Participants | Ondansetron 4mg Pre-emergence | Ondansetron 8mg Pre-emergence | Ondansetron Pre-Incision and Pre-emergence |
|---|---|---|---|
| Nausea | 9 | 4 | 1 |
| Vomiting | 1 | 1 | 0 |
| Headache | 5 | 5 | 3 |
Number participants who needed rescue anti-emetics, i.e,, additional treatments needed to control nausea or vomiting in the PACU
| Participants | Ondansetron 4mg Pre-emergence | Ondansetron 8mg Pre-emergence | Ondansetron Pre-Incision and Pre-emergence |
|---|---|---|---|
| Number of Participants Who Needed Rescue Anti-emetics | 4 | 1 | 2 |
| minutes | Ondansetron 4mg Pre-emergence | Ondansetron 8mg Pre-emergence | Ondansetron Pre-Incision and Pre-emergence |
|---|---|---|---|
| Total Anesthesia Time | 116.0 (93.0 to 178.0) | 128.5 (86.5 to 186.25) | 118.0 (93.0 to 172.0) |
Collected over 1 day. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ondansetron 4mg Pre-emergence | 0/43 (0%) | 0/43 (0%) | 0/43 (0%) |
| Ondansetron 8mg Pre-emergence | 0/42 (0%) | 0/42 (0%) | 0/42 (0%) |
| Ondansetron Pre-Incision and Pre-emergence | 0/43 (0%) | 0/43 (0%) | 0/43 (0%) |
| Age, Continuous(years) | Ondansetron 4mg Pre-emergence | Ondansetron 8mg Pre-emergence | Ondansetron Pre-Incision and Pre-emergence | Total |
|---|---|---|---|---|
| Median | 40 (33 to 51) | 39 (30 to 51) | 48 (31 to 57) | 40 (30 to 57) |
| Sex: Female, Male(Participants) | Ondansetron 4mg Pre-emergence | Ondansetron 8mg Pre-emergence | Ondansetron Pre-Incision and Pre-emergence | Total |
|---|---|---|---|---|
| Female | 41 | 36 | 37 | 114 |
| Male | 2 | 6 | 6 | 14 |
| Race and Ethnicity Not Collected(Participants) | Ondansetron 4mg Pre-emergence | Ondansetron 8mg Pre-emergence | Ondansetron Pre-Incision and Pre-emergence | Total |
|---|---|---|---|---|
| Count of participants | — | — | — | 0 |
| ASA Class(units on a scale) | Ondansetron 4mg Pre-emergence | Ondansetron 8mg Pre-emergence | Ondansetron Pre-Incision and Pre-emergence | Total |
|---|---|---|---|---|
| Median | 1 (1 to 2) | 1 (1 to 2) | 1 (1 to 2) | 1 (1 to 2) |
| BMI(kg/m^2) | Ondansetron 4mg Pre-emergence | Ondansetron 8mg Pre-emergence | Ondansetron Pre-Incision and Pre-emergence | Total |
|---|---|---|---|---|
| Median | 24.0 (21.0 to 27.0) | 25.0 (22.0 to 29.2) | 24.0 (21.0 to 28.6) | 24 (21 to 29.2) |
| History of PONV(Participants) | Ondansetron 4mg Pre-emergence | Ondansetron 8mg Pre-emergence | Ondansetron Pre-Incision and Pre-emergence | Total |
|---|---|---|---|---|
| Count of participants | 12 | 8 | 13 | 33 |
| History of Vertigo(Participants) | Ondansetron 4mg Pre-emergence | Ondansetron 8mg Pre-emergence | Ondansetron Pre-Incision and Pre-emergence | Total |
|---|---|---|---|---|
| Count of participants | 1 | 1 | 2 | 4 |
| History of Motion Sickness(Participants) | Ondansetron 4mg Pre-emergence | Ondansetron 8mg Pre-emergence | Ondansetron Pre-Incision and Pre-emergence | Total |
|---|---|---|---|---|
| Count of participants | 13 | 10 | 17 | 40 |
1 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Oct 2017 to primary completion in Apr 2019, 17 months.
Results were first posted in Jul 2020, 1 year 3 months after primary completion.
Of 31 non-industry phase 4 interventional studies under Vomiting, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 43. This study's 17 months is close to that.
Counting every sponsor, half of 41 studies reached it within 17 months; a quarter within 8 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ondansetron
Icahn School of Medicine at Mount Sinai →