MedDataX Logo

Efficacy and Tolerability of Intranasal Fentanyl Spray for the Treatment of Breakthrough Pain in Cancer Patients Older Than 18 Years

NCT ID: NCT00994760

Last Updated: 2012-09-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

131 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of the study was to evaluate the safety and efficacy of intranasal fentanyl spray in cancer patients over four weeks, especially during cancer-related breakthrough pain (BTP) attacks. The fentanyl spray was applied into the nose by a metered-spray device. The study was to provide further data on pharmacoeconomic efficiency of intranasal fentanyl spray.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breakthrough Pain Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

intranasal fentanyl spray

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

GENISIS

Instanyl (Intranasal Fentanyl)

Intervention Type DRUG

This was an observational study. Therefore, the physician decided about dosage according to individual needs.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Instanyl (Intranasal Fentanyl)

This was an observational study. Therefore, the physician decided about dosage according to individual needs.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* decision to start treatment with intranasal fentanyl spray
* written informed consent

Exclusion Criteria

* criteria as defined in the Summary of Product Characteristics (Fachinformation Chapter 4.3)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dr. Thomas D. Bethke, PhD; MD

Role: STUDY_DIRECTOR

Nycomed Deutschland GmbH, 78467 Konstanz, Germany

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Nycomed Deutschland GmbH

Aachen, , Germany

Site Status

Nycomed Deutschland GmbH

Adendorf, , Germany

Site Status

Nycomed Deutschland GmbH

Aichach, , Germany

Site Status

Nycomed Deutschland GmbH

Albstadt, , Germany

Site Status

Nycomed Deutschland GmbH

Albstadt-Ebingen, , Germany

Site Status

Nycomed Deutschland GmbH

Altenkirchen, , Germany

Site Status

Nycomed Deutschland GmbH

Aschaffenburg, , Germany

Site Status

Nycomed Deutschland GmbH

Aschersleben, , Germany

Site Status

Nycomed Deutschland GmbH

Augsburg, , Germany

Site Status

Nycomed Deutschland GmbH

Augsburg, , Germany

Site Status

Nycomed Deutschland GmbH

Backnang, , Germany

Site Status

Nycomed Deutschland GmbH

Bad Bevensen, , Germany

Site Status

Nycomed Deutschland GmbH

Bad Dürkheim, , Germany

Site Status

Nycomed Deutschland GmbH

Bad Liebenstein, , Germany

Site Status

Nycomed Deutschland GmbH

Bad Pyrmont, , Germany

Site Status

Nycomed Deutschland GmbH

Bad Schwalbach, , Germany

Site Status

Nycomed Deutschland GmbH

Badel, , Germany

Site Status

Nycomed Deutschland GmbH

Bademühlen, , Germany

Site Status

Nycomed Deutschland GmbH

Bautzen, , Germany

Site Status

Nycomed Deutschland GmbH

Berlin, , Germany

Site Status

Nycomed Deutschland GmbH

Berlin, , Germany

Site Status

Nycomed Deutschland GmbH

Berlin, , Germany

Site Status

Nycomed Deutschland GmbH

Berlin, , Germany

Site Status

Nycomed Deutschland GmbH

Berlin, , Germany

Site Status

Nycomed Deutschland GmbH

Berlin, , Germany

Site Status

Nycomed Deutschland GmbH

Berlin, , Germany

Site Status

Nycomed Deutschland GmbH

Berlin, , Germany

Site Status

Nycomed Deutschland GmbH

Berlin, , Germany

Site Status

Nycomed Deutschland GmbH

Bochum, , Germany

Site Status

Nycomed Deutschland GmbH

Bonn, , Germany

Site Status

Nycomed Deutschland GmbH

Böblingen, , Germany

Site Status

Nycomed Deutschland GmbH

Brandenburg/Havel, , Germany

Site Status

Nycomed Deutschland GmbH

Braunschweig, , Germany

Site Status

Nycomed Deutschland GmbH

Bremen, , Germany

Site Status

Nycomed Deutschland GmbH

Brühl, , Germany

Site Status

Nycomed Deutschland GmbH

Burg, , Germany

Site Status

Nycomed Deutschland GmbH

Burg/Fehmarn, , Germany

Site Status

Nycomed Deutschland GmbH

Burscheid, , Germany

Site Status

Nycomed Deutschland GmbH

Butzbach, , Germany

Site Status

Nycomed Deutschland GmbH

Coburg, , Germany

Site Status

Nycomed Deutschland GmbH

Cochem, , Germany

Site Status

Nycomed Deutschland GmbH

Cologne, , Germany

Site Status

Nycomed Deutschland GmbH

Cologne, , Germany

Site Status

Nycomed Deutschland GmbH

Cologne, , Germany

Site Status

Nycomed Deutschland GmbH

Cologne, , Germany

Site Status

Nycomed Deutschland GmbH

Cologne, , Germany

Site Status

Nycomed Deutschland GmbH

Cologne, , Germany

Site Status

Nycomed Deutschland GmbH

Cologne, , Germany

Site Status

Nycomed Deutschland GmbH

Cottbus, , Germany

Site Status

Nycomed Deutschland GmbH

Cuxhaven, , Germany

Site Status

Nycomed Deutschland GmbH

Cuxhaven, , Germany

Site Status

Nycomed Deutschland GmbH

Dessau, , Germany

Site Status

Nycomed Deutschland GmbH

Dresden, , Germany

Site Status

Nycomed Deutschland GmbH

Dresden, , Germany

Site Status

Nycomed Deutschland GmbH

Dresden, , Germany

Site Status

Nycomed Deutschland GmbH

Duisburg, , Germany

Site Status

Nycomed Deutschland GmbH

Düsseldorf, , Germany

Site Status

Nycomed Deutschland GmbH

Essen, , Germany

Site Status

Nycomed Deutschland GmbH

Etzenricht, , Germany

Site Status

Nycomed Deutschland GmbH

Fehmarn, , Germany

Site Status

Nycomed Deutschland GmbH

Frankfurt, , Germany

Site Status

Nycomed Deutschland GmbH

Frankfurt, , Germany

Site Status

Nycomed Deutschland GmbH

Frankfurt, , Germany

Site Status

Nycomed Deutschland GmbH

Freiburg im Breisgau, , Germany

Site Status

Nycomed Deutschland GmbH

Friedberg, , Germany

Site Status

Nycomed Deutschland GmbH

Geesthacht, , Germany

Site Status

Nycomed Deutschland GmbH

Göppingen, , Germany

Site Status

Nycomed Deutschland GmbH

Görlitz, , Germany

Site Status

Nycomed Deutschland GmbH

Großheirath-Rossach, , Germany

Site Status

Nycomed Deutschland GmbH

Gütersloh, , Germany

Site Status

Nycomed Deutschland GmbH

Hachenburg, , Germany

Site Status

Nycomed Deutschland GmbH

Hainburg, , Germany

Site Status

Nycomed Deutschland GmbH

Halle, , Germany

Site Status

Nycomed Deutschland GmbH

Halle, , Germany

Site Status

Nycomed Deutschland GmbH

Hamburg, , Germany

Site Status

Nycomed Deutschland GmbH

Hamburg, , Germany

Site Status

Nycomed Deutschland GmbH

Hamelin, , Germany

Site Status

Nycomed Deutschland GmbH

Hanover, , Germany

Site Status

Nycomed Deutschland GmbH

Hanover, , Germany

Site Status

Nycomed Deutschland GmbH

Hanover, , Germany

Site Status

Nycomed Deutschland GmbH

Heidelberg, , Germany

Site Status

Nycomed Deutschland GmbH

Hellenthal, , Germany

Site Status

Nycomed Deutschland GmbH

Herne, , Germany

Site Status

Nycomed Deutschland GmbH

Herzlake, , Germany

Site Status

Nycomed Deutschland GmbH

Hohberg, , Germany

Site Status

Nycomed Deutschland GmbH

Hohberg-Hofweiler, , Germany

Site Status

Nycomed Deutschland GmbH

Holzminden, , Germany

Site Status

Nycomed Deutschland GmbH

Husum, , Germany

Site Status

Nycomed Deutschland GmbH

Iserlohn, , Germany

Site Status

Nycomed Deutschland GmbH

Itzehoe, , Germany

Site Status

Nycomed Deutschland GmbH

Jerichow, , Germany

Site Status

Nycomed Deutschland GmbH

Kaiserslautern, , Germany

Site Status

Nycomed Deutschland GmbH

Karlsbad, , Germany

Site Status

Nycomed Deutschland GmbH

Katzhütte, , Germany

Site Status

Nycomed Deutschland GmbH

Kevelaar, , Germany

Site Status

Nycomed Deutschland GmbH

Kiel, , Germany

Site Status

Nycomed Deutschland GmbH

Kiel, , Germany

Site Status

Nycomed Deutschland GmbH

Kiel, , Germany

Site Status

Nycomed Deutschland GmbH

Kirchberg, , Germany

Site Status

Nycomed Deutschland GmbH

Koblenz, , Germany

Site Status

Nycomed Deutschland GmbH

Koblenz, , Germany

Site Status

Nycomed Deutschland GmbH

Köthen, , Germany

Site Status

Nycomed Deutschland GmbH

Krefeld, , Germany

Site Status

Nycomed Deutschland GmbH

Krefeld, , Germany

Site Status

Nycomed Deutschland GmbH

Krefeld, , Germany

Site Status

Nycomed Deutschland GmbH

Laatzen, , Germany

Site Status

Nycomed Deutschland GmbH

Lage/Lippe, , Germany

Site Status

Nycomed Deutschland GmbH

Landshut, , Germany

Site Status

Nycomed Deutschland GmbH

Leipzig, , Germany

Site Status

Nycomed Deutschland GmbH

Leverkusen, , Germany

Site Status

Nycomed Deutschland GmbH

Ludwigshafen, , Germany

Site Status

Nycomed Deutschland GmbH

Magdeburg, , Germany

Site Status

Nycomed Deutschland GmbH

Magdeburg, , Germany

Site Status

Nycomed Deutschland GmbH

Magdeburg, , Germany

Site Status

Nycomed Deutschland GmbH

Mainz, , Germany

Site Status

Nycomed Deutschland GmbH

Mannheim, , Germany

Site Status

Nycomed Deutschland GmbH

Mannheim, , Germany

Site Status

Nycomed Deutschland GmbH

Mayen, , Germany

Site Status

Nycomed Deutschland GmbH

Meinersen, , Germany

Site Status

Nycomed Deutschland GmbH

München, , Germany

Site Status

Nycomed Deutschland GmbH

Nastätten, , Germany

Site Status

Nycomed Deutschland GmbH

Naumburg, , Germany

Site Status

Nycomed Deutschland GmbH

Neubrandenburg, , Germany

Site Status

Nycomed Deutschland GmbH

Neubrandenburg, , Germany

Site Status

Nycomed Deutschland GmbH

Neuss, , Germany

Site Status

Nycomed Deutschland GmbH

Neustadt, , Germany

Site Status

Nycomed Deutschland GmbH

Neustadt, , Germany

Site Status

Nycomed Deutschland GmbH

Nordhorn, , Germany

Site Status

Nycomed Deutschland GmbH

Olpe, , Germany

Site Status

Nycomed Deutschland GmbH

Osloß, , Germany

Site Status

Nycomed Deutschland GmbH

Osnabrück, , Germany

Site Status

Nycomed Deutschland GmbH

Osnabrück, , Germany

Site Status

Nycomed Deutschland GmbH

Pforzheim, , Germany

Site Status

Nycomed Deutschland GmbH

Plate, , Germany

Site Status

Nycomed Deutschland GmbH

Plüderhausen, , Germany

Site Status

Nycomed Deutschland GmbH

Potsdam, , Germany

Site Status

Nycomed Deutschland GmbH

Potsdam-Babelsberg, , Germany

Site Status

Nycomed Deutschland GmbH

Pulheim-Stommeln, , Germany

Site Status

Nycomed Deutschland GmbH

Quedlinburg, , Germany

Site Status

Nycomed Deutschland GmbH

Rheine, , Germany

Site Status

Nycomed Deutschland GmbH

Rosenfeld, , Germany

Site Status

Nycomed Deutschland GmbH

Rostock, , Germany

Site Status

Nycomed Deutschland GmbH

Rostock, , Germany

Site Status

Nycomed Deutschland GmbH

Rostock, , Germany

Site Status

Nycomed Deutschland GmbH

Sangerhausen, , Germany

Site Status

Nycomed Deutschland GmbH

Sankt Michaelisdonn, , Germany

Site Status

Nycomed Deutschland GmbH

Schleswig, , Germany

Site Status

Nycomed Deutschland GmbH

Siegen, , Germany

Site Status

Nycomed Deutschland GmbH

Solingen, , Germany

Site Status

Nycomed Deutschland GmbH

Stendal, , Germany

Site Status

Nycomed Deutschland GmbH

Stuttgart, , Germany

Site Status

Nycomed Deutschland GmbH

Tangermünde, , Germany

Site Status

Nycomed Deutschland GmbH

Ulm, , Germany

Site Status

Nycomed Deutschland GmbH

Ulm, , Germany

Site Status

Nycomed Deutschland GmbH

Ulm, , Germany

Site Status

Nycomed Deutschland GmbH

Varel, , Germany

Site Status

Nycomed Deutschland GmbH

Velbert, , Germany

Site Status

Nycomed Deutschland GmbH

Villingen-Schwenningen, , Germany

Site Status

Nycomed Deutschland GmbH

Wedel, , Germany

Site Status

Nycomed Deutschland GmbH

Weinsberg, , Germany

Site Status

Nycomed Deutschland GmbH

Werdau, , Germany

Site Status

Nycomed Deutschland GmbH

Wesendorf, , Germany

Site Status

Nycomed Deutschland GmbH

Westhausen, , Germany

Site Status

Nycomed Deutschland GmbH

Wiesbaden, , Germany

Site Status

Nycomed Deutschland GmbH

Wiesbaden, , Germany

Site Status

Nycomed Deutschland GmbH

Wilster, , Germany

Site Status

Nycomed Deutschland GmbH

Zwickau, , Germany

Site Status

Nycomed Deutschland GmbH

Zwönitz, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FT-1301-401-DE

Identifier Type: -

Identifier Source: org_study_id