Summary
EudraCT Number:2018-004081-34
Sponsor's Protocol Code Number:V.000369
National Competent Authority:Netherlands - Competent Authority
Clinical Trial Type:EEA CTA
Trial Status:Completed
Date on which this record was first entered in the EudraCT database:2019-09-16
Trial results
A. Protocol Information
A.1Member State ConcernedNetherlands - Competent Authority
A.2EudraCT number2018-004081-34
A.3Full title of the trial
The effect of oxytocin on patient-physician relationships: a placebo controlled study
A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
Oxytocin and the relationship between doctor and patient.

Oxytocine en de relatie tussen arts en patient
A.3.2Name or abbreviated title of the trial where available
OCCHIO
A.4.1Sponsor's protocol code numberV.000369
A.7Trial is part of a Paediatric Investigation Plan No
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Yes
D.2.1.1.1Trade name Syntocinon nasal spray
D.2.1.1.2Name of the Marketing Authorisation holderSigma Tau
D.2.1.2Country which granted the Marketing AuthorisationNetherlands
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameOxytocin
D.3.2Product code Oxytocin
D.3.4Pharmaceutical form Nasal spray
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPNasal use
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product No
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.8 Information on Placebo
D.8 Placebo: 1
D.8.1Is a Placebo used in this Trial?Yes
D.8.3Pharmaceutical form of the placeboNasal spray, solution
D.8.4Route of administration of the placeboIntranasal use (Noncurrent)
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
Healthy individuals
E.1.1.1Medical condition in easily understood language
Healthy individuals
E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Psychological processes [F02]
MedDRA Classification
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
Understand the underlying mechanisms of the relationship between patient and physician.
E.2.2Secondary objectives of the trial
Not applicable
E.2.3Trial contains a sub-study No
E.3Principal inclusion criteria
Healthy, male subjects aged 18 to 35 years

Subjects must be in good general health

Refrain from alcohol/smoking/caffeine/drugs 24 hrs before the experiment

Refrained from food/drinks (except water) and intensive exercise two hours before the administration of oxytocin

Previous experience with healthcare system, in order to ensure that the subject is able to put himself in the role of a patient

Subjects must be able to communicate well with the investigator in Dutch, to understand and comply with the requirements of the study, and understand and sign the written informed consent

E.4Principal exclusion criteria
Known hypersensitivity to oxytocin or to any of the excipients of oxytocin or placebo

Participants who did not abstain from alcohol/smoking/caffeine/drugs 24 hrs before the experiment

Participants who did not abstain from food/drinks (except water) and intensive exercise two hours before the administration of oxytocin

Participants who did not meet the above specified inclusion criteria
E.5 End points
E.5.1Primary end point(s)
Level of eye gaze from participant towards the eye area of the physician.

Levels of participants’ trust in the physician.


E.5.1.1Timepoint(s) of evaluation of this end point
Level of eye gaze: during the first video session and during the second video session.

Levels of participants’ trust: after the first video session and after the second video session.
E.5.2Secondary end point(s)
Satisfaction with the physician: Measured with a visual analogue scale (VAS) ranging from 0 (not likely at all) to 100 (most likely) asking “I would recommend this doctor to a friend or family member.”

Pupillometry: The measurement of pupil size and reactivity (dilation and restriction), measured with the Tobii screen eye tracker.

Satisfaction with the doctors’ communication style: Measured with the Doctor Communication Style items (translated to Dutch with forward-backward translation) on two subscales: affiliativeness and dominance/activity. Items are answered on a 5-point Likert Scale from “strongly agree” to “strongly disagree”.

Recall & Recognition (of information as explained during the medical communication video): Questionnaire which assesses participants’ level of free recall and recognition of information provided by the videotaped physician. The questionnaire will be designed based on the information provided in the video.
E.5.2.1Timepoint(s) of evaluation of this end point
Satisfaction with the physician: after the first video session and after the second video session.

Pupillometry: during the first video session and during the second video session.

Satisfaction with the doctors’ communication style: after the first video session and after the second video session.

Recall & Recognition:after the first video session and after the second video session.
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis No
E.6.2Prophylaxis No
E.6.3Therapy No
E.6.4Safety No
E.6.5Efficacy No
E.6.6Pharmacokinetic No
E.6.7Pharmacodynamic No
E.6.8Bioequivalence No
E.6.9Dose response No
E.6.10Pharmacogenetic No
E.6.11Pharmacogenomic No
E.6.12Pharmacoeconomic No
E.6.13Others Yes
E.6.13.1Other scope of the trial description
Understand the role of oxytocin with regard to the relationship between patient and physician.
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) No
E.7.1.1First administration to humans No
E.7.1.2Bioequivalence study No
E.7.1.3Other No
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) No
E.7.3Therapeutic confirmatory (Phase III) No
E.7.4Therapeutic use (Phase IV) Yes
E.8 Design of the trial
E.8.1Controlled Yes
E.8.1.1Randomised Yes
E.8.1.2Open No
E.8.1.3Single blind No
E.8.1.4Double blind Yes
E.8.1.5Parallel group No
E.8.1.6Cross over Yes
E.8.1.7Other No
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) No
E.8.2.2Placebo Yes
E.8.2.3Other No
E.8.2.4Number of treatment arms in the trial2
E.8.3 The trial involves single site in the Member State concerned Yes
E.8.4 The trial involves multiple sites in the Member State concerned No
E.8.5The trial involves multiple Member States No
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA No
E.8.6.2Trial being conducted completely outside of the EEA No
E.8.7Trial has a data monitoring committee No
E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
LVLS
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years1
E.8.9.1In the Member State concerned months0
E.8.9.1In the Member State concerned days0
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 No
F.1.1.1In Utero No
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
F.1.1.3Newborns (0-27 days) No
F.1.1.4Infants and toddlers (28 days-23 months) No
F.1.1.5Children (2-11years) No
F.1.1.6Adolescents (12-17 years) No
F.1.2Adults (18-64 years) Yes
F.1.2.1Number of subjects for this age range: 76
F.1.3Elderly (>=65 years) No
F.2 Gender
F.2.1Female No
F.2.2Male Yes
F.3 Group of trial subjects
F.3.1Healthy volunteers Yes
F.3.2Patients No
F.3.3Specific vulnerable populations No
F.3.3.1Women of childbearing potential not using contraception No
F.3.3.2Women of child-bearing potential using contraception No
F.3.3.3Pregnant women No
F.3.3.4Nursing women No
F.3.3.5Emergency situation No
F.3.3.6Subjects incapable of giving consent personally No
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state76
F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
none
G. Investigator Networks to be involved in the Trial
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2019-09-16
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2019-07-29
P. End of Trial
P.End of Trial StatusCompleted
P.Date of the global end of the trial2021-01-29