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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00557258
Other study ID # 248.652
Secondary ID
Status Completed
Phase N/A
First received November 9, 2007
Last updated February 12, 2009
Start date November 2007

Study information

Verified date February 2009
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Germany: Ethik-Kommission der Ärztekammer Bremen Ethik-Komission der Landesärztekammer Hessen Ethik-Komission der Ärztekammer NordrheinUnited States: Food and Drug Administration
Study type Observational

Clinical Trial Summary

The proposed study is a Cross-sectional epidemiological study, performed in 330 primary care practices in Germany. The study will be conducted on a fixed day in November 2007.

Primary care surgeries throughout Germany will be asked to take part. The study material will be delivered to the surgery by a member of sales-force who will also explain the study conduct to the physician/staff. Physicians who want to take part in the study will send a signed contract to BI. Physicians will be trained to diagnose RLS.

All patients attending the participating surgeries on a fixed day will be invited to participate in the study. The patients will be handed a questionnaire to fill out while waiting for their appointment. No patient-related data apart from gender and year of birth will be recorded on the questionnaire and it will be ensured that no re-identification of patients is possible. Therefore, no written informed consent will be obtained from the participants.

The patient questionnaire will consist of the following items:

A screening questionnaire for RLS (according to Stiasny-Kolster et. al., data on file) Additional questions concerning the impact of the patients leg problems on daily life.

The practice staff will then collect the questionnaire. All patients who have answered question 1 (asking for unpleasant sensations of the legs) with ¿Yes¿ will subsequently be assessed for the diagnosis by the physician.

The physician fills out a second questionnaire, covering the following items:

Diagnosis (cause of leg problems) Concomitant diagnoses and therapies If the diagnosis of RLS was made: consequences (therapy)? Was the diagnosis of RLS pre-known? All completed questionnaires will be sent to data management by the surgery within 2 working days.


Recruitment information / eligibility

Status Completed
Enrollment 14956
Est. completion date
Est. primary completion date November 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients attending one of the participating primary care surgeries on a fixed day

- Male or female patients of any age

Exclusion Criteria:

- Patients who only attend the practice to get a prescription and are not seen by the doctor on that day.

- Patients who are not able to understand the questionnaire due to mental impairment or language problems.

- Children and adolescents under the age of 18 years

Study Design

N/A


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Boehringer Ingelheim Investigational Site Aachen
Germany Boehringer Ingelheim Investigational Site Aalen
Germany Boehringer Ingelheim Investigational Site Ahlen
Germany Boehringer Ingelheim Investigational Site Altena
Germany Boehringer Ingelheim Investigational Site Altensteig
Germany Boehringer Ingelheim Investigational Site Altomünster
Germany Boehringer Ingelheim Investigational Site Alveslohe
Germany Boehringer Ingelheim Investigational Site Annaberg-Buchholz
Germany Boehringer Ingelheim Investigational Site Apolda
Germany Boehringer Ingelheim Investigational Site Artern
Germany Boehringer Ingelheim Investigational Site Aschersleben
Germany Boehringer Ingelheim Investigational Site Aub
Germany Boehringer Ingelheim Investigational Site Babenhausen
Germany Boehringer Ingelheim Investigational Site Bad Bevensen
Germany Boehringer Ingelheim Investigational Site Bad Buchau
Germany Boehringer Ingelheim Investigational Site Bad Essen
Germany Boehringer Ingelheim Investigational Site Bad Krozingen
Germany Boehringer Ingelheim Investigational Site Bad Laasphe
Germany Boehringer Ingelheim Investigational Site Bad Langensalza
Germany Boehringer Ingelheim Investigational Site Bad Schussenried
Germany Boehringer Ingelheim Investigational Site Bautzen
Germany Boehringer Ingelheim Investigational Site Bergholz-Rehbrücke
Germany Boehringer Ingelheim Investigational Site Berlin
Germany Boehringer Ingelheim Investigational Site Bernburg
Germany Boehringer Ingelheim Investigational Site Bernsdorf
Germany Boehringer Ingelheim Investigational Site Bevern
Germany Boehringer Ingelheim Investigational Site Biberach
Germany Boehringer Ingelheim Investigational Site Bienenbüttel
Germany Boehringer Ingelheim Investigational Site Birkenwerder
Germany Boehringer Ingelheim Investigational Site Bisingen
Germany Boehringer Ingelheim Investigational Site Bodelshausen
Germany Boehringer Ingelheim Investigational Site Bodenwöhr
Germany Boehringer Ingelheim Investigational Site Bornheim
Germany Boehringer Ingelheim Investigational Site Braunschweig
Germany Boehringer Ingelheim Investigational Site Bremen
Germany Boehringer Ingelheim Investigational Site Bückeburg
Germany Boehringer Ingelheim Investigational Site Buckenhof
Germany Boehringer Ingelheim Investigational Site Büdelsdorf
Germany Boehringer Ingelheim Investigational Site Bünde
Germany Boehringer Ingelheim Investigational Site Burgdorf
Germany Boehringer Ingelheim Investigational Site Burgheim
Germany Boehringer Ingelheim Investigational Site Burgoberbach
Germany Boehringer Ingelheim Investigational Site Calbe
Germany Boehringer Ingelheim Investigational Site Calw
Germany Boehringer Ingelheim Investigational Site Castrop-Rauxel
Germany Boehringer Ingelheim Investigational Site Celle
Germany Boehringer Ingelheim Investigational Site Chemnitz
Germany Boehringer Ingelheim Investigational Site Coppenbrügge
Germany Boehringer Ingelheim Investigational Site Cottbus
Germany Boehringer Ingelheim Investigational Site Cuxhaven
Germany Boehringer Ingelheim Investigational Site Dänischenhagen
Germany Boehringer Ingelheim Investigational Site Daun
Germany Boehringer Ingelheim Investigational Site Delligsen
Germany Boehringer Ingelheim Investigational Site Denkendorf
Germany Boehringer Ingelheim Investigational Site Dillingen
Germany Boehringer Ingelheim Investigational Site Donauwörth
Germany Boehringer Ingelheim Investigational Site Dörentrup
Germany Boehringer Ingelheim Investigational Site Dormagen
Germany Boehringer Ingelheim Investigational Site Dorn-Dürkheim
Germany Boehringer Ingelheim Investigational Site Dortmund
Germany Boehringer Ingelheim Investigational Site Dreieich
Germany Boehringer Ingelheim Investigational Site Dresden
Germany Boehringer Ingelheim Investigational Site Duisburg
Germany Boehringer Ingelheim Investigational Site Düren
Germany Boehringer Ingelheim Investigational Site Düsseldorf
Germany Boehringer Ingelheim Investigational Site Edenkoben
Germany Boehringer Ingelheim Investigational Site Eisingen
Germany Boehringer Ingelheim Investigational Site Elsenfeld
Germany Boehringer Ingelheim Investigational Site Emsdetten
Germany Boehringer Ingelheim Investigational Site Eppelheim
Germany Boehringer Ingelheim Investigational Site Erftstadt
Germany Boehringer Ingelheim Investigational Site Erfurt
Germany Boehringer Ingelheim Investigational Site Erlangen
Germany Boehringer Ingelheim Investigational Site Erndtebrück
Germany Boehringer Ingelheim Investigational Site Eschau
Germany Boehringer Ingelheim Investigational Site Essen
Germany Boehringer Ingelheim Investigational Site Esslingen
Germany Boehringer Ingelheim Investigational Site Eutin
Germany Boehringer Ingelheim Investigational Site Extertal
Germany Boehringer Ingelheim Investigational Site Falkensee
Germany Boehringer Ingelheim Investigational Site Frankfurt
Germany Boehringer Ingelheim Investigational Site Freiburg
Germany Boehringer Ingelheim Investigational Site Freising
Germany Boehringer Ingelheim Investigational Site Friedenfels
Germany Boehringer Ingelheim Investigational Site Friedrichsthal
Germany Boehringer Ingelheim Investigational Site Fulda
Germany Boehringer Ingelheim Investigational Site Fürstenwalde
Germany Boehringer Ingelheim Investigational Site Geiselhöring
Germany Boehringer Ingelheim Investigational Site Gelsenkirchen
Germany Boehringer Ingelheim Investigational Site Gensingen
Germany Boehringer Ingelheim Investigational Site Germering
Germany Boehringer Ingelheim Investigational Site Gladbeck
Germany Boehringer Ingelheim Investigational Site Glashütten
Germany Boehringer Ingelheim Investigational Site Göttingen
Germany Boehringer Ingelheim Investigational Site Greiz
Germany Boehringer Ingelheim Investigational Site Grömitz
Germany Boehringer Ingelheim Investigational Site Großenkneten
Germany Boehringer Ingelheim Investigational Site Großenlüder
Germany Boehringer Ingelheim Investigational Site Haag
Germany Boehringer Ingelheim Investigational Site Hagen
Germany Boehringer Ingelheim Investigational Site Halle
Germany Boehringer Ingelheim Investigational Site Haltern
Germany Boehringer Ingelheim Investigational Site Hamburg
Germany Boehringer Ingelheim Investigational Site Hamminkeln
Germany Boehringer Ingelheim Investigational Site Hanerau-Hademarschen
Germany Boehringer Ingelheim Investigational Site Hannover
Germany Boehringer Ingelheim Investigational Site Harsewinkel
Germany Boehringer Ingelheim Investigational Site Hartenstein
Germany Boehringer Ingelheim Investigational Site Hattorf
Germany Boehringer Ingelheim Investigational Site Heilbronn
Germany Boehringer Ingelheim Investigational Site Heinsberg
Germany Boehringer Ingelheim Investigational Site Herbertshofen
Germany Boehringer Ingelheim Investigational Site Herbrechtingen
Germany Boehringer Ingelheim Investigational Site Hermsdorf
Germany Boehringer Ingelheim Investigational Site Hohenhameln
Germany Boehringer Ingelheim Investigational Site Hosena
Germany Boehringer Ingelheim Investigational Site Hude
Germany Boehringer Ingelheim Investigational Site Ippesheim
Germany Boehringer Ingelheim Investigational Site Ispringen
Germany Boehringer Ingelheim Investigational Site Jahnsdorf
Germany Boehringer Ingelheim Investigational Site Jever
Germany Boehringer Ingelheim Investigational Site Jühnde
Germany Boehringer Ingelheim Investigational Site Jünkerath
Germany Boehringer Ingelheim Investigational Site Kahl
Germany Boehringer Ingelheim Investigational Site Kalbach
Germany Boehringer Ingelheim Investigational Site Kamen
Germany Boehringer Ingelheim Investigational Site Kassel
Germany Boehringer Ingelheim Investigational Site Katzhütte
Germany Boehringer Ingelheim Investigational Site Kaufbeuren
Germany Boehringer Ingelheim Investigational Site Kirchardt
Germany Boehringer Ingelheim Investigational Site Kirchheim
Germany Boehringer Ingelheim Investigational Site Kirchlengern
Germany Boehringer Ingelheim Investigational Site Kitzingen
Germany Boehringer Ingelheim Investigational Site Köln
Germany Boehringer Ingelheim Investigational Site Kressbronn
Germany Boehringer Ingelheim Investigational Site Kronach
Germany Boehringer Ingelheim Investigational Site Kropp
Germany Boehringer Ingelheim Investigational Site Krumbach
Germany Boehringer Ingelheim Investigational Site Kuppenheim
Germany Boehringer Ingelheim Investigational Site Laatzen
Germany Boehringer Ingelheim Investigational Site Lahnau
Germany Boehringer Ingelheim Investigational Site Lahr
Germany Boehringer Ingelheim Investigational Site Lampertheim
Germany Boehringer Ingelheim Investigational Site Langen
Germany Boehringer Ingelheim Investigational Site Langenfeld
Germany Boehringer Ingelheim Investigational Site Lauf
Germany Boehringer Ingelheim Investigational Site Leer
Germany Boehringer Ingelheim Investigational Site Lehrberg
Germany Boehringer Ingelheim Investigational Site Leipzig
Germany Boehringer Ingelheim Investigational Site Lengefeld
Germany Boehringer Ingelheim Investigational Site Leonberg
Germany Boehringer Ingelheim Investigational Site Leverkusen
Germany Boehringer Ingelheim Investigational Site Lienen
Germany Boehringer Ingelheim Investigational Site Lohfelden
Germany Boehringer Ingelheim Investigational Site Lohra
Germany Boehringer Ingelheim Investigational Site Lüderitz
Germany Boehringer Ingelheim Investigational Site Ludwigshafen
Germany Boehringer Ingelheim Investigational Site Lunzenau
Germany Boehringer Ingelheim Investigational Site Lütjenburg
Germany Boehringer Ingelheim Investigational Site Magdeburg
Germany Boehringer Ingelheim Investigational Site Mannheim
Germany Boehringer Ingelheim Investigational Site Marburg
Germany Boehringer Ingelheim Investigational Site Meerbusch
Germany Boehringer Ingelheim Investigational Site Meldorf
Germany Boehringer Ingelheim Investigational Site Mendig
Germany Boehringer Ingelheim Investigational Site Mengkofen
Germany Boehringer Ingelheim Investigational Site Meßstetten
Germany Boehringer Ingelheim Investigational Site Mindelheim
Germany Boehringer Ingelheim Investigational Site Mittweida
Germany Boehringer Ingelheim Investigational Site Mönchengladbach
Germany Boehringer Ingelheim Investigational Site Moosburg
Germany Boehringer Ingelheim Investigational Site Mosbach
Germany Boehringer Ingelheim Investigational Site Mühlhausen
Germany Boehringer Ingelheim Investigational Site Mülheim
Germany Boehringer Ingelheim Investigational Site München
Germany Boehringer Ingelheim Investigational Site Niederndodeleben
Germany Boehringer Ingelheim Investigational Site Nienburg
Germany Boehringer Ingelheim Investigational Site Nürnberg
Germany Boehringer Ingelheim Investigational Site Oberdorla
Germany Boehringer Ingelheim Investigational Site Oberursel
Germany Boehringer Ingelheim Investigational Site Oer-Erkenschwick
Germany Boehringer Ingelheim Investigational Site Olbernhau
Germany Boehringer Ingelheim Investigational Site Olfen
Germany Boehringer Ingelheim Investigational Site Osnabrück
Germany Boehringer Ingelheim Investigational Site Ostrach
Germany Boehringer Ingelheim Investigational Site Parey
Germany Boehringer Ingelheim Investigational Site Petershagen
Germany Boehringer Ingelheim Investigational Site Pirmasens
Germany Boehringer Ingelheim Investigational Site Plattling
Germany Boehringer Ingelheim Investigational Site Pleidelsheim
Germany Boehringer Ingelheim Investigational Site Potsdam
Germany Boehringer Ingelheim Investigational Site Pulheim
Germany Boehringer Ingelheim Investigational Site Rastede
Germany Boehringer Ingelheim Investigational Site Remscheid
Germany Boehringer Ingelheim Investigational Site Rhaunen
Germany Boehringer Ingelheim Investigational Site Roggendorf
Germany Boehringer Ingelheim Investigational Site Rossau
Germany Boehringer Ingelheim Investigational Site Rostock
Germany Boehringer Ingelheim Investigational Site Röthenbach
Germany Boehringer Ingelheim Investigational Site Saerbeck
Germany Boehringer Ingelheim Investigational Site Schönau
Germany Boehringer Ingelheim Investigational Site Schönebeck
Germany Boehringer Ingelheim Investigational Site Schorndorf
Germany Boehringer Ingelheim Investigational Site Schwäbisch Gmünd
Germany Boehringer Ingelheim Investigational Site Schwarzenbach a Wald
Germany Boehringer Ingelheim Investigational Site Schwerte
Germany Boehringer Ingelheim Investigational Site Seelow
Germany Boehringer Ingelheim Investigational Site Selfkant
Germany Boehringer Ingelheim Investigational Site Senftenberg
Germany Boehringer Ingelheim Investigational Site Siegen
Germany Boehringer Ingelheim Investigational Site Sögel
Germany Boehringer Ingelheim Investigational Site Solingen
Germany Boehringer Ingelheim Investigational Site Sonsbeck
Germany Boehringer Ingelheim Investigational Site Speyer
Germany Boehringer Ingelheim Investigational Site Sprendlingen
Germany Boehringer Ingelheim Investigational Site Stadland
Germany Boehringer Ingelheim Investigational Site Stadthagen
Germany Boehringer Ingelheim Investigational Site Straubing
Germany Boehringer Ingelheim Investigational Site Stuhr
Germany Boehringer Ingelheim Investigational Site Stutensee
Germany Boehringer Ingelheim Investigational Site Stuttgart
Germany Boehringer Ingelheim Investigational Site Suhl
Germany Boehringer Ingelheim Investigational Site Sulzbach
Germany Boehringer Ingelheim Investigational Site Sulzbach-Rosenberg
Germany Boehringer Ingelheim Investigational Site Teterow
Germany Boehringer Ingelheim Investigational Site Tettnang
Germany Boehringer Ingelheim Investigational Site Thaleischweiler-Fröschen
Germany Boehringer Ingelheim Investigational Site Troisdorf
Germany Boehringer Ingelheim Investigational Site Veilsdorf
Germany Boehringer Ingelheim Investigational Site Vellahn
Germany Boehringer Ingelheim Investigational Site Viernheim
Germany Boehringer Ingelheim Investigational Site Villingen-Schwenningen
Germany Boehringer Ingelheim Investigational Site Waghäusel
Germany Boehringer Ingelheim Investigational Site Wehrsdorf
Germany Boehringer Ingelheim Investigational Site Weibern
Germany Boehringer Ingelheim Investigational Site Weimar
Germany Boehringer Ingelheim Investigational Site Welzheim
Germany Boehringer Ingelheim Investigational Site Wemding
Germany Boehringer Ingelheim Investigational Site Wertingen
Germany Boehringer Ingelheim Investigational Site Wesel
Germany Boehringer Ingelheim Investigational Site Wesseling
Germany Boehringer Ingelheim Investigational Site Wetzendorf
Germany Boehringer Ingelheim Investigational Site Wetzlar
Germany Boehringer Ingelheim Investigational Site Wickede
Germany Boehringer Ingelheim Investigational Site Wiesbaden
Germany Boehringer Ingelheim Investigational Site Winsen
Germany Boehringer Ingelheim Investigational Site Wöbbelin
Germany Boehringer Ingelheim Investigational Site Zschocken
Germany Boehringer Ingelheim Investigational Site Zschopau
Germany Boehringer Ingelheim Investigational Site Zweibrücken
Germany Boehringer Ingelheim Investigational Site Zwickau

Sponsors (1)

Lead Sponsor Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

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