Treatment of Patients Suffering From Nervous Restlessness With PASCOFLAIR®

NCT02651922 | Completed Results

• 1 other identifier: 199A14PF
• Study Type: observational
• Target: 154
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study was carried out as a prospective, non-interventional study with the intention of subsequent process cost analyses (PCA) and also considers quality of life, drug misuse, dependence, adverse events and therapy satisfaction.

Conditions

Nervous Restlessness

Keywords

Nervous restlessness; Pascoflair; Passiflora incarnata; Benzodiazepine

Outcome Measures

Primary Outcomes (1)

• Change of Symptom Inner Restlessness (Pre - Post)

  Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms"

  Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)

Secondary Outcomes (13)

• Change of Symptom Sleep Disturbance (Pre - Post)

  Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)

• Change of Symptom Exhaustion (Pre - Post)

  Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)

• Change of Symptom Fear (Pre - Post)

  Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)

• Change of Symptom Lack of Concentration (Pre - Post)

  Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)

• Change of Symptom Transpiration (Pre - Post)

  Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline )

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients had to suffer from nervous restlessness in order to be eligible for study documentation.

You may qualify if:

• patients suffering from nervous restlessness

You may not qualify if:

• Age \< 18 years and must be able to read and understand the patient declaration of data protection and the declaration of consent
• alcoholics, drug pending, addictive disorder
• pregnancy or lactating
• patients showing hypersensitivity against passionflower extract or against other components of the medication

Sponsors & Collaborators

• Pascoe Pharmazeutische Praeparate GmbH: lead
• Institut für Empirische Gesundheitsökonomie, Prof. Dr. Dr.med. Reinhard Rychlik,Am Ziegelfeld 28,51399 Burscheid,Germany: collaborator

Results Point of Contact

• Title: Dr. Inga Trompetter and Jennifer Lebert
• Organization: PASCOE Pharmazeutische Präparate GmbH

Jennifer.lebert@pascoe.de

0049-(0)641-7960-955

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2016
• First Posted: January 11, 2016
• Study Start: September 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 30, 2024
• Results First Posted: June 19, 2017

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share