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Trial record 14 of 15 for:    Passiflora

Treatment of Patients Suffering From Nervous Restlessness With PASCOFLAIR®

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ClinicalTrials.gov Identifier: NCT02651922
Recruitment Status : Completed
First Posted : January 11, 2016
Results First Posted : June 19, 2017
Last Update Posted : June 19, 2017
Sponsor:
Collaborator:
Institut für Empirische Gesundheitsökonomie, Prof. Dr. Dr.med. Reinhard Rychlik,Am Ziegelfeld 28,51399 Burscheid,Germany
Information provided by (Responsible Party):
Pascoe Pharmazeutische Praeparate GmbH

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Nervous Restlessness
Enrollment 154
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PASCOFLAIR Group (Verum)
Hide Arm/Group Description Patients who were treated with PASCOFLAIR
Period Title: Overall Study
Started 156
Completed 154
Not Completed 2
Reason Not Completed
due to exclusion criteria             2
Arm/Group Title PASCOFLAIR Group (Verum)
Hide Arm/Group Description Patients who were treated with PASCOFLAIR
Overall Number of Baseline Participants 154
Hide Baseline Analysis Population Description
A total of 156 patients participated in the study. Two patients were excluded from the analysis, because they received Benzodiazepines (Tavor, Lexostad). One patient was 17 years of age when documented in the study. The overall study population considered in the analyses was 154 patients.
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 154 participants
<=18 years 1
Between 18 and 65 years 128
>=65 years 23
missing data 2
[1]
Measure Description: 2 missinig data
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 154 participants
47.9  (17.1)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 154 participants
Female 115
Male 38
missing data 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 154 participants
154
1.Primary Outcome
Title Change of Symptom Inner Restlessness (Pre - Post)
Hide Description Symptom was assessed in a Likert scale ranging from 0 “no symptoms at all” to 10 “very severe symptoms”
Time Frame Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description

If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent.

Only 146 patients showed this symptom.

Arm/Group Title PASCOFLAIR Group (Verum)
Hide Arm/Group Description:
Patients who were treated with PASCOFLAIR
Overall Number of Participants Analyzed 146
Measure Type: Number
Unit of Measure: participants
improved 137
unchanged 3
detoriated 6
2.Secondary Outcome
Title Change of Symptom Sleep Disturbance (Pre - Post)
Hide Description Symptom was assessed in a Likert scale ranging from 0 “no symptoms at all” to 10 “very severe symptoms”
Time Frame Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description

If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent.

Only 146 patients showed this symptom.

Arm/Group Title PASCOFLAIR Group (Verum)
Hide Arm/Group Description:
Patients who were treated with PASCOFLAIR
Overall Number of Participants Analyzed 146
Measure Type: Number
Unit of Measure: participants
improved 131
unchanged 8
deteriorated 7
3.Secondary Outcome
Title Change of Symptom Exhaustion (Pre - Post)
Hide Description Symptom was assessed in a Likert scale ranging from 0 “no symptoms at all” to 10 “very severe symptoms”
Time Frame Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description

If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent.

Only 145 patients showed this symptom.

Arm/Group Title PASCOFLAIR Group (Verum)
Hide Arm/Group Description:
Patients who were treated with PASCOFLAIR
Overall Number of Participants Analyzed 145
Measure Type: Number
Unit of Measure: participants
improved 130
unchanged 7
detoriorated 8
4.Secondary Outcome
Title Change of Symptom Fear (Pre - Post)
Hide Description Symptom was assessed in a Likert scale ranging from 0 “no symptoms at all” to 10 “very severe symptoms”
Time Frame Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description

If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent.

Only 133 patients showed this symptom.

Arm/Group Title PASCOFLAIR Group (Verum)
Hide Arm/Group Description:
Patients who were treated with PASCOFLAIR
Overall Number of Participants Analyzed 133
Measure Type: Number
Unit of Measure: participants
improved 121
unchanged 6
detoriorated 10
5.Secondary Outcome
Title Change of Symptom Lack of Concentration (Pre - Post)
Hide Description Symptom was assessed in a Likert scale ranging from 0 “no symptoms at all” to 10 “very severe symptoms”
Time Frame Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description

If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent.

Only 142 patients showed this symptom.

Arm/Group Title PASCOFLAIR Group (Verum)
Hide Arm/Group Description:
Patients who were treated with PASCOFLAIR
Overall Number of Participants Analyzed 142
Measure Type: Number
Unit of Measure: participants
improved 123
unchanged 11
detoriorated 8
6.Secondary Outcome
Title Change of Symptom Transpiration (Pre - Post)
Hide Description Symptom was assessed in a Likert scale ranging from 0 “no symptoms at all” to 10 “very severe symptoms”
Time Frame Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline )
Hide Outcome Measure Data
Hide Analysis Population Description

If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent.

Only 121 patients showed this symptom.

Arm/Group Title PASCOFLAIR Group (Verum)
Hide Arm/Group Description:
Patients who were treated with PASCOFLAIR
Overall Number of Participants Analyzed 121
Measure Type: Number
Unit of Measure: participants
improved 106
unchanged 9
detoriorated 6
7.Secondary Outcome
Title Change of Symptom Nausea (Pre - Post)
Hide Description Symptom was assessed in a Likert scale ranging from 0 “no symptoms at all” to 10 “very severe symptoms”
Time Frame Change from Baseline (before treatment; week 0) to last visit (end of observation-approx. 12 weeks after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description

If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent.

Only 92 patients showed this symptom.

Arm/Group Title PASCOFLAIR Group (Verum)
Hide Arm/Group Description:
Patients who were treated with PASCOFLAIR
Overall Number of Participants Analyzed 92
Measure Type: Number
Unit of Measure: participants
improved 79
unchnaged 7
detoriorated 6
8.Secondary Outcome
Title Change of Symptom Trembling (Pre - Post)
Hide Description Symptom was assessed in a Likert scale ranging from 0 “no symptoms at all” to 10 “very severe symptoms”
Time Frame Change from Baseline (before treatment; week 0) to last visit (end of observation - approx. 12 weeks after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description

If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent.

Only 108 patients showed this symptom.

Arm/Group Title PASCOFLAIR Group (Verum)
Hide Arm/Group Description:
Patients who were treated with PASCOFLAIR
Overall Number of Participants Analyzed 108
Measure Type: Number
Unit of Measure: participants
improved 91
unchanged 8
deterioreated 9
9.Secondary Outcome
Title Change of Symptom Palpation (Pre - Post)
Hide Description Symptom was assessed in a Likert scale ranging from 0 “no symptoms at all” to 10 “very severe symptoms”
Time Frame Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description

If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent.

Only 130 patients showed this symptom.

Arm/Group Title PASCOFLAIR Group (Verum)
Hide Arm/Group Description:
Patients who were treated with PASCOFLAIR
Overall Number of Participants Analyzed 130
Measure Type: Number
Unit of Measure: participants
improved 117
unchanged 9
deteriorated 4
10.Secondary Outcome
Title Change of BDEPQ (Benzodiazepine Dependence Questionnaire)
Hide Description

The Benzodiazepine Dependence Questionnaire (BDEPQ) is a 30 item self report questionnaire designed to measure dependence on benzodiazepine tranquilisers, sedatives and hypnotics. Items cover all aspects of the dependence syndrome with the exception of withdrawal symptoms. Each item is rated on a four point likert scale referring to experiences in the last month.

BDEPQ score ranges from 0 (no dependence) to 85 (most severe dependence).

Time Frame Change from visit 2 (approx. 4 weeks after baseline) to last visit (end of observation- approx. 12 weeks after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description

For patient with less than 75% items answered the BDEPQ-Score was not calculated.

For only 132 patients Score was calculated.

Arm/Group Title PASCOFLAIR Group (Verum)
Hide Arm/Group Description:
Patients who were treated with PASCOFLAIR
Overall Number of Participants Analyzed 132
Measure Type: Number
Unit of Measure: participants
improved 91
unchanged 13
deteriorated 28
11.Secondary Outcome
Title Change of RS-13 (Resilience Questionnaire) (Pre - Post)
Hide Description RS-13 is a 13 items self Report questionnaire measure the resilience, which applies a reliance scale ranging from 13 (lowest stress resistance) to 91 (highest stress resistance).
Time Frame Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PASCOFLAIR Group (Verum)
Hide Arm/Group Description:
Patients who were treated with PASCOFLAIR
Overall Number of Participants Analyzed 132
Measure Type: Number
Unit of Measure: participants
improved 115
unchanged 3
deteriorated 14
12.Secondary Outcome
Title Change in EQ-5D (Health Questionnaire) Scores (Pre - Post)
Hide Description EQ-5D™ is a standardised instrument for use as a measure of health Outcome The EQ-5D assesses five aspects of QoL: mobility, self-care, usual activity, pain/discomfort and anxiety/depression. An EQ-5D profile score of 0 points represents the worst QoL (death), while 1 point stands for full health. Data analysis was performed according to the EuroQol manual. The EQ-VAS ranges from 0 (worst QoL) to 100 (best QoL).
Time Frame Change from Baseline (before treatment) to last visit (end of observation- approx. 12 weeks after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PASCOFLAIR Group (Verum)
Hide Arm/Group Description:
Patients who were treated with PASCOFLAIR
Overall Number of Participants Analyzed 133
Measure Type: Number
Unit of Measure: participants
improved 104
unchanged 22
deterioreated 7
13.Secondary Outcome
Title Change of EQ-5D VAS Scores (Pre - Post)
Hide Description VAS values (Quality of Life) range from 0 (very poor) to 100 (best possible state).
Time Frame Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PASCOFLAIR Group (Verum)
Hide Arm/Group Description:
Patients who were treated with PASCOFLAIR
Overall Number of Participants Analyzed 134
Measure Type: Number
Unit of Measure: participants
improved 119
unchanged 5
deteriorated 11
14.Secondary Outcome
Title Tolerability Assess Using a 5 Point Scale
Hide Description Assessment of tolerability using a 5 point scale (very good, good, satisfactory, bad, very bad)
Time Frame Evaluation of Tolerability on visit 3 (appr. 12 weeks after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PASCOFLAIR Group (Verum)
Hide Arm/Group Description:
Patients who were treated with PASCOFLAIR
Overall Number of Participants Analyzed 148
Measure Type: Number
Unit of Measure: participants
very good 109
good 35
satisfactory 2
bad 1
very bad 1
Time Frame The observational period was from September 2014 till June 2015. Per Patient were adrs collected for the treatment period (12 weeks).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PASCOFLAIR Group (Verum)
Hide Arm/Group Description Patients who were treated with PASCOFLAIR
All-Cause Mortality
PASCOFLAIR Group (Verum)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
PASCOFLAIR Group (Verum)
Affected / at Risk (%) # Events
Total   0/154 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1.0%
PASCOFLAIR Group (Verum)
Affected / at Risk (%) # Events
Total   3/154 (1.95%)    
Gastrointestinal disorders   
Fatigue  1  3/154 (1.95%)  3
Nervous system disorders   
Numbness in limbs  1  1/154 (0.65%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Inga Trompetter and Jennifer Lebert
Organization: PASCOE Pharmazeutische Präparate GmbH
Phone: 0049-(0)641-7960-955
Responsible Party: Pascoe Pharmazeutische Praeparate GmbH
ClinicalTrials.gov Identifier: NCT02651922     History of Changes
Other Study ID Numbers: 199A14PF
First Submitted: January 6, 2016
First Posted: January 11, 2016
Results First Submitted: April 21, 2016
Results First Posted: June 19, 2017
Last Update Posted: June 19, 2017