CancerERKENTNISNCT01400854

Effentora® in Clinical Practice - a Non-interventional Study to Evaluate Satisfaction and Tolerability

An observational study of Cancer and Pain, run by Cephalon at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Aim of this non-interventional study is to investigate the tolerability of Effentora® in cancer pain patients with breakthrough pain under real-life conditions in clinical practice. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cancer, Pain
What is being tested?: Effentora®
How many people: 600 participants
Where: 1 siteGermany
Study dates: Jul 2011to Oct 2012
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Adult cancer patients (in- or out-patients) that are suffering from breakthrough pain

Who may be able to join

decision to start treatment with Effentora
prescription in accordance with Summary of Product Characteristics (SmPC)
personally signed and dated Informed Consent document

Who cannot join

any subject considered unsuitable according to SmPC

Trial locations and contacts

1 site in 1 country.

Germany1 site

Cephalon GmbH
Munich, Bavaria, 80339

Other trials in Germany

About this study

Official title: ERKENTNIS: Effentora® in Clinical Practice - a Non-interventional Study to Evaluate Satisfaction and Tolerability

Aim of this non-interventional study is to investigate the tolerability of Effentora® in cancer pain patients with breakthrough pain under real-life conditions in clinical practice.

Read the detailed description

In addition to the effectiveness of Effentora® therapy, safety, general feasibility and the impact of therapy on the patients' quality of life are of interest.

Conditions: Cancer, Pain
Being tested: Effentora®
Keywords: breakthrough cancer pain
Medical subject headings: Neoplasms, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Effentora®Drug
prescribed as per local Summary of Product Characteristics (SmPC) for 4 weeks duration

Study groups in NCT01400854
Study group	Role	What they receive
Effentora®		Single group prospective treatment cohort Receives: Drug: Effentora®

What is being measured

The primary outcome is the main question the study is designed to answer.

pain relief
to show adequate pain relief within 10 minutes
Measured: 4 weeks

Secondary outcomes (4)

occurrence of adverse events
document the tolerability of Effentora®
Measured: 4 weeks
Change in level of breakthrough pain
pursue the possible changes in the history of breakthrough pain during treatment with Effentora
Measured: 4 weeks
presence of specific triggers for breakthrough pain
to investigate the presence of specific triggers (directly or indirectly) with breakthrough pain
Measured: 4 weeks
quality of life
to document the impact of breakthrough pain in different areas of patients' lives and their changes during treatment with Effentora®
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2011Oct 2012

First posted22 Jul 2011 (estimated)
Study startJul 2011
Primary completionOct 2012
Study completionOct 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 600 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01400854
Sponsor's protocol ID: C25608/5008
Acronym: ERKENTNIS
Status last verified: Oct 2012
First submitted: 21 Jul 2011
Last updated: 24 Oct 2012
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 24 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ERKENTNIS: Effentora® in Clinical Practice - a Non-interventional Study to Evaluate Satisfaction and Tolerability
ClinicalTrials.gov ID: NCT01400854
Acronym / sponsor ID: ERKENTNIS / C25608/5008
Conditions: Cancer, Pain
Keywords: breakthrough cancer pain
Study type: Observational
Recruitment status: Completed
Enrolment: 600 participants (actual)
Lead sponsor: CephalonIndustry (pharma, biotech, devices)
Study start: Jul 2011
Primary completion: Oct 2012 (actual)
Study completion: Oct 2012 (actual)
First posted: 22 Jul 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Aim of this non-interventional study is to investigate the tolerability of Effentora® in cancer pain patients with breakthrough pain under real-life conditions in clinical practice.

Detailed description

In addition to the effectiveness of Effentora® therapy, safety, general feasibility and the impact of therapy on the patients' quality of life are of interest.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Effentora®	–	Drug: Effentora®Single group prospective treatment cohort

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Adult cancer patients (in- or out-patients) that are suffering from breakthrough pain

Key inclusion criteria (3 listed)

decision to start treatment with Effentora
prescription in accordance with Summary of Product Characteristics (SmPC)
personally signed and dated Informed Consent document

Key exclusion criteria (1 listed)

any subject considered unsuitable according to SmPC

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Effentora®prescribed as per local Summary of Product Characteristics (SmPC) for 4 weeks duration	Drug	Effentora®

Primary outcome

pain relief
Time frame: 4 weeks
to show adequate pain relief within 10 minutes

4 secondary outcomes

occurrence of adverse events
Time frame: 4 weeks
Change in level of breakthrough pain
Time frame: 4 weeks
presence of specific triggers for breakthrough pain
Time frame: 4 weeks
quality of life
Time frame: 4 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2012.

Related trials for Cancer

Not yet recruitingPhase 3
Zopapogene Imadenovec for the Treatment of Recurrent Respiratory Papillomatosis in Children
Recurrent Respiratory Papillomatosis (RRP), Juvenile-onset Recurrent Respiratory Papillomatosis
RecruitingPhase 2
A Clinical Trial Testing the Safety of the Investigational Drug Pumitamig (BNT327) and How Well it Works in Patients With Recurrent Glioblastoma
Recurrent Glioblastoma
Recruiting
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Colorectal Neoplasms, Colorectal Cancer (Diagnosis)
Recruiting
Implementation of a Pain Management Plan in Major Open Abdominal Surgeries.
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Department study director

Cephalon

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer and Pain, run by Cephalon at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pain relief (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01400854.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2012.