Trial Outcomes & Findings for Pilot Study on the Efficacy of Pascoflair in an Acute Stressful Situation (TSST) (NCT NCT01665170)

NCT ID: NCT01665170

Last Updated: 2015-12-09

Results Overview

The primary objective is to assess effects of P. incarnata on psychological stress measured by Visual Analogue Scales (VAS; Bond and Lader 1974) by comparing scores collected before, during and after stress exposure between the P. incarnata and a placebo group. In this study, psychological stress is defined as stress perception, anxiety and insecurity. These three variables are determined simultaneously in the study before, during and after the stress test. Minimum = 0 mm; Maximum = 100 mm, higher value = represent a worsend outcome.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 60 participants
• Primary outcome timeframe: during stress test = Visite 3
• Results posted on: 2015-12-09

Participant Flow

Individuals will be recruited via newspaper, mailing lists and radio advertisement in the area of Trier,Germany by DAaCRO. Recruiting: May 2012 - July 2012 in medical center/ CRO for Trier Social Sress Tests.

Three subjects were not included because the recruitment phase was already completed.

Participant milestones

Measure	Placebo Placebo arm, 3 x 1 tablet per every day for 3 days	Verum Verum arm - Pascoflair 425mg, 3 x 1 tablet per every day for 3 days
Overall Study STARTED	30	30
Overall Study Bevore TSST	30	30
Overall Study During TSST	30	30
Overall Study After TSST	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Study on the Efficacy of Pascoflair in an Acute Stressful Situation (TSST)

Baseline characteristics by cohort

Measure	Placebo n=30 Participants Placebo arm	Verum n=30 Participants Verum arm - Pascoflair 425mg	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	28.57 years STANDARD_DEVIATION 5.00 • n=5 Participants	28.47 years STANDARD_DEVIATION 5.81 • n=7 Participants	28.5 years STANDARD_DEVIATION 5.78 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Region of Enrollment Germany	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: during stress test = Visite 3

The primary objective is to assess effects of P. incarnata on psychological stress measured by Visual Analogue Scales (VAS; Bond and Lader 1974) by comparing scores collected before, during and after stress exposure between the P. incarnata and a placebo group. In this study, psychological stress is defined as stress perception, anxiety and insecurity. These three variables are determined simultaneously in the study before, during and after the stress test. Minimum = 0 mm; Maximum = 100 mm, higher value = represent a worsend outcome.

Outcome measures

Measure	Placebo n=30 Participants Placebo arm	Verum n=30 Participants Verum arm - Pascoflair 425mg
VAS Insecurity (During)	56.87 mm Standard Deviation 30.92	60.93 mm Standard Deviation 30.39

PRIMARY outcome

Timeframe: during stress test = Visite 3

The primary objective is to assess effects of P. incarnata on psychological stress measured by Visual Analogue Scales (VAS; Bond and Lader 1974) by comparing scores collected before, during and after stress exposure between the P. incarnata and a placebo group. In this study, psychological stress is defined as stress perception, anxiety and insecurity. These three variables are determined simultaneously in the study before, during and after the stress test. Minimum = 0 mm; Maximum = 100 mm, higher value = represent a worsend outcome.

Outcome measures

Measure	Placebo n=30 Participants Placebo arm	Verum n=30 Participants Verum arm - Pascoflair 425mg
VAS Anxiety (During)	29.67 mm Standard Deviation 30.39	34.17 mm Standard Deviation 30.92

PRIMARY outcome

Timeframe: during stress test = Visite 3

The primary objective is to assess effects of P. incarnata on psychological stress measured by Visual Analogue Scales (VAS; Bond and Lader 1974) by comparing scores collected before, during and after stress exposure between the P. incarnata and a placebo group. In this study, psychological stress is defined as stress perception, anxiety and insecurity. These three variables are determined simultaneously in the study before, during and after the stress test. Minimum = 0 mm; Maximum = 100 mm, higher value = represent a worsend outcome.

Outcome measures

Measure	Placebo n=30 Participants Placebo arm	Verum n=30 Participants Verum arm - Pascoflair 425mg
VAS Stress Perception (During)	59.20 mm Standard Deviation 28.77	57.3 mm Standard Deviation 29.42

SECONDARY outcome

Timeframe: 1 day

2 min. prior to and 1 min. after the TSST

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 day

ACTH - Adrenocorticotropes Hormon - 2 min. prior to and 1 min. after the TSST

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 day

2 min. prior the TSST

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: before stress test

2 min. prior the TSST

Outcome measures

Measure	Placebo n=28 Participants Placebo arm	Verum n=30 Participants Verum arm - Pascoflair 425mg
Norepinephrine (Before)	430.29 ng/dl Standard Deviation 121.41	581.17 ng/dl Standard Deviation 160.82

SECONDARY outcome

Timeframe: 1 day

The STAI-X1 measures state anxiety (one scale). Answers are given on a four-point rating scale ranging from 1 = "not at all" to 4 = "very true". The questionnaire is used as baseline measurement at V2. In addition, it is also employed before and immediately after the stress test at V3 to assess changes in state anxiety. Assess V2, before and after V3

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 day

The POMS assesses the four states depression/anxiety, fatigue, vigor and hostility (4 scales). High vigor scores reflect a positive mood whereas high scores in the other subscales indicate negative mood. Subjects rate their mood state on a 7-point rating scale ranging from 1 = "not at all" to 7 = "very strongly". The questionnaire is completed on V2 and V3.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 day

The MDBF assesses the three bipolar dimensions good/bad mood, wakefulness/tiredness and calmness/agitation (3 scales). The short form of the MDBF and its parallel version (versions A and B) each consist of 12 items. Subjects rate their mood state on a 5-point rating scale ranging from 1 = "not at all" to 5 = "very true". To determine mood changes induced by the TSST, the questionnaire is completed shortly before (version A) and immediately after the TSST (version B). Assess before and after V3

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Visite 2 (before treatment), Visite 3 (after treatment)

The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3.

V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded. The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.

Outcome measures

Measure	Placebo n=30 Participants Placebo arm	Verum n=29 Participants Verum arm - Pascoflair 425mg
LSEQ Questionnaire (Getting to Sleep-Falling Asleep Easier Than Usual) - Changes From V2 to V3	2.90 Percent Change Standard Deviation 24.23	11.21 Percent Change Standard Deviation 23.73

SECONDARY outcome

Timeframe: Visite 2 (before treatment), Visite 3 (after treatment)

The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.

The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.

Outcome measures

Measure	Placebo n=30 Participants Placebo arm	Verum n=30 Participants Verum arm - Pascoflair 425mg
LSEQ Questionnaire (Getting to Sleep-Falling Asleep More Quickly Than Usual] - Changes From V2 to V3	0.63 Percent Change Standard Deviation 25.78	11.47 Percent Change Standard Deviation 26.83

SECONDARY outcome

Timeframe: Visite 2 (before treatment), Visite 3 (after treatment)

The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.

The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; lower values represent a better outcome.

Outcome measures

Measure	Placebo n=30 Participants Placebo arm	Verum n=30 Participants Verum arm - Pascoflair 425mg
LSEQ Questionnaire (Getting to Sleep-Feeling More Drowsy Than Usual] - Changes From V2 to V3	3.67 Percent Change Standard Deviation 24.75	-12.53 Percent Change Standard Deviation 23.35

SECONDARY outcome

Timeframe: Visite 2 (before treatment), Visite 3 (after treatment)

The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.

The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.

Outcome measures

Measure	Placebo n=30 Participants Placebo arm	Verum n=29 Participants Verum arm - Pascoflair 425mg
LSEQ Questionnaire (Quality of Sleep - More Restful Than Usual] - Changes From V2 to V3	1.53 Percent Change Standard Deviation 24.52	13.38 Percent Change Standard Deviation 26.81

SECONDARY outcome

Timeframe: Visite 2, visite 3

The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.

The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.

Outcome measures

Measure	Placebo n=30 Participants Placebo arm	Verum n=29 Participants Verum arm - Pascoflair 425mg
LSEQ Questionnaire (Quality of Sleep - Fewer Periods of Wakefulness Than Usual] Changes From V2 to V3	5.47 Percent Change Standard Deviation 27.80	14.59 Percent Change Standard Deviation 28.21

SECONDARY outcome

Timeframe: Visite 2 (before treatment), Visite 3 (after treatment)

The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.

The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.

Outcome measures

Measure	Placebo n=30 Participants Placebo arm	Verum n=29 Participants Verum arm - Pascoflair 425mg
LSEQ Questionnaire (Awakening From Sleep- Easier Than Usual] Changes From V2 to V3	-0.33 Percent Change Standard Deviation 28.30	10.28 Percent Change Standard Deviation 27.23

SECONDARY outcome

Timeframe: Visite 2 (before treatment), Visite 3 (after treatment)

The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.

The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.

Outcome measures

Measure	Placebo n=30 Participants Placebo arm	Verum n=29 Participants Verum arm - Pascoflair 425mg
LSEQ Questionnaire (Awakening From Sleep- Quicker Than Usual] Changes From V2 to V3	-6.07 Percent Change Standard Deviation 28.28	1.00 Percent Change Standard Deviation 29.64

SECONDARY outcome

Timeframe: Visite 2 (before treatment), Visite 3 (after treatment)

The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.

The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.

Outcome measures

Measure	Placebo n=30 Participants Placebo arm	Verum n=30 Participants Verum arm - Pascoflair 425mg
LSEQ Questionnaire (Behavior Following Awakening- Feeling Alert Upon Awakening] Changes From V2 to V3	5.63 Percent Change Standard Deviation 26.58	17.17 Percent Change Standard Deviation 23.90

SECONDARY outcome

Timeframe: Visite 2 (before treatment), Visite 3 (after treatment)

The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3.

V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.

The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.

Outcome measures

Measure	Placebo n=30 Participants Placebo arm	Verum n=29 Participants Verum arm - Pascoflair 425mg
LSEQ Questionnaire (Behavior Following Awakening- Feeling Alert Now] Changes From V2 to V3	6.60 Percent Change Standard Deviation 32.92	19.17 Percent Change Standard Deviation 28.04

SECONDARY outcome

Timeframe: Visite 2 (before treatment), Visite 3 (after treatment)

The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.

The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; a higher value is a better outcome.

Outcome measures

Measure	Placebo n=29 Participants Placebo arm	Verum n=30 Participants Verum arm - Pascoflair 425mg
LSEQ Questionnaire (Behavior Following Awakening- Less Clumsy Balance and Coordination Upon Getting-up] Changes From V2 to V3	-3.40 Percent Change Standard Deviation 16.53	1.66 Percent Change Standard Deviation 13.43

SECONDARY outcome

Timeframe: 1 day

2 min. after the TSST, higher value is better

Outcome measures

Measure	Placebo n=28 Participants Placebo arm	Verum n=29 Participants Verum arm - Pascoflair 425mg
Norepinephrine (After)	670.11 ng/dl Standard Deviation 204.61	803.14 ng/dl Standard Deviation 202.05

SECONDARY outcome

Timeframe: before TSST

Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.

Outcome measures

Measure	Placebo n=30 Participants Placebo arm	Verum n=30 Participants Verum arm - Pascoflair 425mg
Sympathovagal Balance (Before TSST, Sitting - 1. Measurement)	18.22 (low frequency/high frequency)*10 Standard Deviation 7.66	22.84 (low frequency/high frequency)*10 Standard Deviation 9.83

SECONDARY outcome

Timeframe: before TSST

Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.

Outcome measures

Measure	Placebo n=30 Participants Placebo arm	Verum n=29 Participants Verum arm - Pascoflair 425mg
Sympathovagal Balance (Before TSST, Standing - 2. Measurement)	27.74 (low frequency/high frequency)*10 Standard Deviation 11.05	33.14 (low frequency/high frequency)*10 Standard Deviation 13.89

SECONDARY outcome

Timeframe: during TSST

Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.

Outcome measures

Measure	Placebo n=30 Participants Placebo arm	Verum n=29 Participants Verum arm - Pascoflair 425mg
Sympathovagal Balance (During TSST, Preparation - 3. Measurement)	33.23 (low frequency/high frequency)*10 Standard Deviation 12.21	38.37 (low frequency/high frequency)*10 Standard Deviation 16.17

SECONDARY outcome

Timeframe: during TSST

Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.

Outcome measures

Measure	Placebo n=30 Participants Placebo arm	Verum n=30 Participants Verum arm - Pascoflair 425mg
Sympathovagal Balance (During TSST, Interview - 4. Measurement)	35.94 (low frequency/high frequency)*10 Standard Deviation 13.94	39.25 (low frequency/high frequency)*10 Standard Deviation 16.56

SECONDARY outcome

Timeframe: during TSST

Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.

Outcome measures

Measure	Placebo n=30 Participants Placebo arm	Verum n=30 Participants Verum arm - Pascoflair 425mg
Sympathovagal Balance (During TSST, Arithmetics - 5. Measurement)	44.01 (low frequency/high frequency)*10 Standard Deviation 24.35	45.53 (low frequency/high frequency)*10 Standard Deviation 20.23

SECONDARY outcome

Timeframe: after TSST

Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.

Outcome measures

Measure	Placebo n=30 Participants Placebo arm	Verum n=30 Participants Verum arm - Pascoflair 425mg
Sympathovagal Balance (After TSST, Standing - 6. Measurement)	42.36 (low frequency/high frequency)*10 Standard Deviation 21.23	43.28 (low frequency/high frequency)*10 Standard Deviation 17.71

SECONDARY outcome

Timeframe: after TSST

Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.

Outcome measures

Measure	Placebo n=30 Participants Placebo arm	Verum n=30 Participants Verum arm - Pascoflair 425mg
Sympathovagal Balance (After TSST, Sitting - 7. Measurement)	26.42 (low frequency/high frequency)*10 Standard Deviation 12.08	29.93 (low frequency/high frequency)*10 Standard Deviation 13.35

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Verum

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Gabriele Weiß

PASCOE pharmazeutische Präparate GmbH

Phone: 0641-7960

Email: klinischeforschung@pascoe.de

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place