Postoperative recovery with the addition of long-acting NK1- and 5-HT3 receptor antagonists as prophylaxis for post-operative nausea and vomiting. A prospective, double-blind, randomized trial in laparoscopic surgery.

2025-522529-36-00 Protocol Palpitant-study Therapeutic confirmatory (Phase III) Authorised, recruitment pending

Status Authorised, recruitment pending · 1 EU/EEA countries · 3 sites · Protocol Palpitant-study

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Authorised, recruitment pending
Participants planned 220
Countries 1
Sites 3

Post-operative nausea and vomiting (PONV)

Is the reduction in QoR-15swe from baseline before surgery to the first postoperative day (POD 1) at least 8.0 points smaller in the intervention group compared to the control group?

Key facts

Sponsor
Region Vaesternorrland, Umea University
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
Decision date (initial)
2025-12-15
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Prophylaxis, Safety

Is the reduction in QoR-15swe from baseline before surgery to the first postoperative day (POD 1) at least 8.0 points smaller in the intervention group compared to the control group?

Secondary objectives 11

  1. Are there differences in the QoR-15swe scores between the study groups during the study period?
  2. Is the proportion of participants with QoR-15swe > 117 (patient-accepted symptom state) on POD1, POD2 and POD3 higher in the intervention group?
  3. Is the proportion of participants with PONV, nausea, vomiting and need for antiemetics (respectively) lower in the intervention group?
  4. Is the maximal pain (NRS) at rest and during movement respectively, lower in the intervention group?
  5. Is the proportion of patients with severe pain (NRS>6) lower in the intervention group?
  6. Is the length of stay in the PACU shorter in the intervention group?
  7. Is time to discharge to home from the hospital shorter in the intervention group?
  8. Is the incidence of side- and adverse effects higher in the intervention group?
  9. Is the proportion of participants with a postoperative complication > grade 1 according to Clavien-Dindo up to POD 30 higher in the intervention group?
  10. Is the proportion of participants requiring a hospital readmission up to POD 30 higher in the intervention group?
  11. Does the intervention improve patient satisfaction and experience?

Conditions and MedDRA coding

Post-operative nausea and vomiting (PONV)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

  1. The subject has given their written consent to participate in the trial
  2. Adult male or female subjects (>=18 years old)
  3. ASA-class I-III
  4. Scheduled for elective laparoscopic bariatric surgery or laparoscopic cholecystectomies under general anesthesia
  5. Women of Childbearing Capacity (WOCBC) only if pregnancy test is negative or if the woman is using highly effective contraception methods

Exclusion criteria 8

  1. Not able to understand and/or cooperative with the study protocol.
  2. Documented allergy or intolerance to the IMPs.
  3. Psychiatric condition or other reasons that jeopardize compliance with follow up.
  4. Breast-feeding females
  5. Intestinal obstruction, accessed by anamnesis or clinical findings.
  6. Immunosuppressive treatment.
  7. Medication with SSRI or SNRI.
  8. Female subjects using anticontraceptive drugs not accepting the need for alternative contraceptive methods for two months (if anticonception is desired by the subject).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. QoR-15swe scores preoperative (baseline) and on POD1

Secondary endpoints 9

  1. QoR-15swe on POD0, POD2 and POD3
  2. Events of nausea or vomiting at PACU, at the hospital and at home up to POD3.
  3. Use of antiemetics at PACU, at the hospital and at home up to POD3.
  4. Pain assessments (NRS) at PACU, during hospital stay and at home up to POD3.
  5. Time at PACU
  6. Time at hospital until discharge.
  7. Events of known side-effect of IMP such as infusion-site reactions, headache, visual disturbances, constipation, diarrhoea and tiredness.
  8. Complications from POD0 to POD 30 according to Clavien-Dindo
  9. Themes from qualitative interviews of patient experiences on postoperative recovery using inductive thematic analysis (30-90 days after first visit)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Fosaprepitant

SUB25384 · Substance

Active substance
Fosaprepitant
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS BOLUS USE
Max daily dose
150 mg milligram(s)
Max total dose
150 mg milligram(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Palonosetron

SUB09593MIG · Substance

Active substance
Palonosetron
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAVENOUS BOLUS USE
Max daily dose
75 µg microgram(s)
Max total dose
75 µg microgram(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Comparator 1

Ondansetron

SUB09445MIG · Substance

Active substance
Ondansetron
Pharmaceutical form
SOLUTON FOR INJECTION
Route of administration
INTRAVENOUS BOLUS USE
Max daily dose
4 mg milligram(s)
Max total dose
4 mg milligram(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Placebo 1

Sodium Chloride

SUB12581MIG · Substance

Active substance
Sodium Chloride
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
500 ml millilitre(s)
Max total dose
500 ml millilitre(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Vaesternorrland

Sponsor organisation
Region Vaesternorrland
Address
Lasarettsvagen 21
City
Sundsvall
Postcode
856 43
Country
Sweden

Scientific contact point

Organisation
Region Vaesternorrland
Contact name
Jakob Walldén

Public contact point

Organisation
Region Vaesternorrland
Contact name
Jakob Walldén

Umea University

7 Total trials 4 Recruiting
Academic / Non-commercial
Sponsor organisation
Umea University
Address
Universitetstorget 4, Alidhem Alidhem
City
Umea
Postcode
907 36
Country
Sweden

Sponsor responsibilities

Article 77 compliance
Region Vaesternorrland
Contact point sponsor
Region Vaesternorrland
Article 77 implementation
Region Vaesternorrland

Locations

1 EU/EEA country · 3 investigational sites

By country

CountryMS statusPlanned subjectsSites
Sweden Authorised, recruitment pending 220 3
Rest of world — 0 —

Investigational sites

Sweden

3 sites · Authorised, recruitment pending
Region Norrbotten
AnOpIVA, Sunderby sjukhus, Robertsviksgatan 7, Lulea Domkyrkofors., Lulea
Region Vaesterbotten
AnOpIVA, Norrlands universitetssjukus Umeå, Koksvagen 11, Alidhem, Umea
Region Vaesternorrland
AnOpIVA, Sundsvall sjukhus, Lasarettsvagen 21, 856 43, Sundsvall

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Flow Chart 2025-522529-36-00 1.0
Protocol (for publication) D1_Instrument-QoR-15swe 2025-522529-36-00 1.0
Protocol (for publication) D1_List of Generic IMP 2025-522529-36-00 1.0
Protocol (for publication) D1_Patient Diary 2025-522529-36-00 1.0
Protocol (for publication) D1_Protocol 2025-522529-36-00 1.1
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Subject information and informed consent form (for publication) L1_SIS and ICF 1.1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Fosaprepitant 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Ondansetron 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Palonosetron 1
Synopsis of the protocol (for publication) D1_Protocol synopsis sv 2025-522529-36-00 1.0

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-10-29 Sweden Acceptable
2025-12-12
 2025-12-15

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