Peripheral Neuropathic PainASCENDNCT01737294
Observation of the Use of QUTENZA™ in Standard Clinical Practice
An observational study of Peripheral Neuropathic Pain, run by Astellas Pharma Europe Ltd. at 50 sites in 7 countries.
Trial summary
This non-interventional study will evaluate the efficacy, tolerability, health related quality of life and use of health resources associated with QUTENZA treatment when QUTENZA is used in standard clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Neuropathic Pain
- What is being tested?
- Qutenza exposure
- How many people
- 429 participants
- Where
- 50 sitesin 7 countries
- Study dates
- Feb 2012to Aug 2014
- 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: Patients receiving QUTENZA for PNP in routine clinical practice
Who may be able to join
- 1. The investigator has decided to treat the patient with QUTENZA as part of provision of standard care for the treatment of peripheral neuropathic pain in non-diabetic adults either alone or in combination with other medicinal products for pain
- 2. The patient is willing and able to comply with protocol requirements for the duration of study participation
Who cannot join
- 1. The neuropathic painful areas are located only on the face, above the hairline of the scalp, and/or in proximity to mucous membranes
- 2. The patient has a history of Type I or Type II diabetes mellitus
- 3. The patient has a diagnosis of any major psychiatric disorder or evidence of cognitive impairment including dementia that, in the opinion of the investigator, may interfere with patient's ability to complete study evaluations
- 4. The patient has received any prior treatment with QUTENZA patches, including blinded patches administered as part of a clinical trial
- 5. The patient has hypersensitivity to capsaicin (i.e. chilli peppers or over-the-counter [OTC] capsaicin products), any QUTENZA excipients or adhesives, or local anesthetics
- 6. The patient has participated in any other clinical study or received an investigational drug within 30 days prior to Screening Visit
- 7. The patient currently engages in any active substance abuse or has a history of chronic substance abuse within 1 year prior to the Screening Visit; or any prior chronic substance abuse (including alcoholism) likely to re-occur during the study period as judged by the investigator
- 8. The patient, in the opinion of the investigator, is not suitable to participate in this NIS for any reason
Trial locations and contacts
50 sites in 7 countries.
50 sites in 7 countries
Greece11 sites
Site 202 Antonios Tavernarakis General Hospital of Athens ''Evangelismos'' - Neurology Clinic
Athens, Attica, 10676
Site 206 Dimosthenis Mitsikostas Hellenic Navy Hospital of Athens - Neurology Clinic
Athens, Attica, 11521
Site 205 Antonios Kodounis 251 General Airforce Hospital of Athens - Neurology Clinic
Athens, Attica, 11525
Site 209 Grigorios Panagopoulos- General Hospital of Athens ''G.Gennimatas'' - Neurology Clinic
Athens, Attica, 11527
Site 211 Panagiotis Kokotis Aeginitio University Hospital of Athens - A' Neurology Clinic
Athens, Attica, 11528
Site 213 Mediterraneo Hospital
Athens
Site 210 General Hospital of Athens ''G.Gennimatas'' - Neurology Clinic, Athens
Attica, 11528
Site 208 Alexandros Papadimitriou University General Hospital of Larisa - Neurology Clinic
Larissa, Larisa, 41110
Site 212 2 Pindarou and Tseva Str, Koumerki
Thebes, 32200
Site 203 Georgios Georgiadis General Hospital of Thessaloniki ''Ippokratio'' - Neurology Clinic
Thessaloniki, Thessaloniki, 54642
Site 204 Nikolaos Vlaikidis General Hospital of Thessaloniki ''G.Papanikolaou'' - 3rd Neurology Clinic
Thessaloniki, Thessaloniki, 57010
Portugal11 sites
Site 608 Hospital Divino Espirito Santo, E.P.E.
Açores, 9500-370
Site 607 Hospital Garcia da Orta
Almada, 2801-951
Site 602 Hospital Professor Dr. Fernando da Fonseca
Amadora, 2720-276
Site 603 Hospital Infante D. Pedro EPE
Aveiro, 3814-501
Site 611 Centro Hospitalar Cova da Beira - Hospital Universitário Quinta do Alvito
Covilha, 6200-251
Site 609 Hospital de Faro
Faro, 8000-386
Site 601 Centro Hospitalar Lisboa Norte- Hospital Santa Maria
Lisbon, 1649-035
Site 605 Hospital S. João da Madeira
Madeirã, 3700-190
Site 606 Centro Hospitalar do Porto-Hospital Santo António
Porto, 4099-001
Site 604 Hospital São João
Porto, 4200 - 319
Site 610 Hospital S. Teotónio
Viseu, 3504-509
Austria7 sites
Site 103 Abteilung für Anästhesiologie und Intensivmedizin LKH Hartberg
Graz, 8020
Site 107 Interdisziplinäre Schmerzambulanz Univ. Klinik f. Anästhesiologie und Intensivmedizin Graz, Auenbruggerplatz 29
Graz, 8036
Site 104 Abteilung für Anästhesie und allgemeine Intensivmedizin Allgemein öffentliches Klinikum-Klagenfurt am Wörthersee St. Veiter Strasse 47
Hartberg, 8230
Site 105 Abteilung für Anästhesiologie und operative Intensivmedizin Allgemeines Krankenhaus Linz Krankenhausstraße 9
Klagenfurt, 9020
Site 106 Interdisziplinäre Schmerzambulanz Univ. Klinik f. Anästhesiologie und Intensivmedizin Graz Auenbruggerplatz 29
Linz, 4021
Site 102 Krankenhaus der Elisabethinen GmbH Abteilung für Anästhesie und Intensivmedizin Elisabethinergasse 14
Vienna, 1020
Site 101 Krankenhaus der Barmherzigen Brüder Abteilung für Anästhesiologie, Intensivmedizin und Schmerztherapie Johannes von Gott Platz 1
Vienna, 1090
Italy7 sites
Site 306 Ospedale regionale "Umberto Parini"
Aosta, AO, 11100
Site 305 Azienda Ospedaliero-Universitaria Consorziale Policlinico
Bari, BA, 70100
Site 308 Spedali Riuniti di Bergamo
Bergamo, BG, 24100
Site 302 Ospedale di Stato della Repubblica di San Marino
Borgo Maggiore, RSM, 47893
Site 301 A.O. Spedali Civili di Brescia
Brescia, BS, 25100
Site 303 L'INM Neuromed, Istituto Neurologico Mediterraneo
Pozzilli, IS, 86077
Site 304 Ospedale SS. Annunziata
Taranto, TA, 74100
Spain7 sites
Site 702 Hospital Municipal de Badalona
Badalona, Barcelona, 8911
Site 703 Fundació Puigvert
Barcelona, Barcelona, 8025
Site 705 Hospital Clinic
Barcelona, Barcelona, 8036
Site 704 Hospital de Basurto
Bilbao, Vizcaya, 48013
Site 707 Hospital de Galdakano
Galdakano, Vizcaya, 48960
Site 706 Complejo Hospitalario de Navarra
Pamplona, Pamplona, 31008
Site 708 Clínica Universitaria de Navarra
Pamplona, Pamplona, 31008
United Kingdom5 sites
Site 804 Royal Infirmary of Edinburgh
Edinburgh, EH16 4SA
Site 803 Western General Hospital
Edinburgh, EH4 2XU
Site 801 Chelsea and Westminster Hospital
London, SW10 9NH
Site 805 Princess Elizabeth Hospital
St Martins, GY1 3EX
Site 802 West Cumberland General Hospital
Whitehaven, Cumbria, CA28 8JG
Switzerland2 sites
Site 902 Leiter der Schmerzklinik Bethesda-Spital Gellertstrasse 144
Basel, 4052
Site 901 Schmerzzentrum St. Gallen Kantonspital St.Gallen
Sankt Gallen, 9007
About this study
Official title: The Use of QUTENZA™ in Standard Clinical Practice: a Phase IV, Multicentre, European Non-interventional Study
This non-interventional study will evaluate the efficacy, tolerability, health related quality of life and use of health resources associated with QUTENZA treatment when QUTENZA is used in standard clinical practice.
The patient's primary diagnosis of peripheral neuropathic pain (PNP) will be classified into subtypes: post-herpetic neuralgia (PHN); HIV-associated neuropathy (HIV-AN); neuropathic back pain; cancer-related neuropathic pain; post-operative \& post-traumatic neuropathic pain; and 'other' neuropathies.
Read the detailed description
A detailed medical history will be taken, with particular emphasis on the primary PNP diagnosis. In addition to all current neuropathic pain medications, all previous therapies (pharmacological and surgical) for PNP from the point of primary diagnosis will be documented.
QUTENZA treatments may be repeated up to every 90 days, in line with the Summary of Product Characteristics document (SPC) as determined by the persistence or return of pain.
Patients who have not required treatment for 365 days or longer may re-enter a treatment cycle if their treating physician decides to retreat them with QUTENZA in the course of standard clinical management.
The duration of participation for each patient will be at least 12 months following first QUTENZA treatment.
Short questionnaires will be completed by the investigator whilst in contact with the patient (either in person or by telephone) at the following time points: 1) Screening prior to the first QUTENZA treatment; 2) at each QUTENZA treatment visit; 3) 2 weeks, 8 weeks following the first QUTENZA treatment 4) 12 weeks following each QUTENZA treatment; 5) any additional contact with the patient outside the protocol schedule.
For patients not returning for retreatment with QUTENZA within any of 6 months, 9 months, and 1 year of their previous QUTENZA treatment further follow-up questionnaires will be completed.
End of study (EoS) is defined as one year after the last patient enrolled receives their first QUTENZA treatment.
- Conditions
- Peripheral Neuropathic Pain
- Being tested
- Qutenza exposure
- Keywords
- Phase IV, Peripheral Neuropathic Pain, QUTENZA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qutenza exposureDrug
Also called Capsaicin
Cutaneous patch
| Study group | Role | What they receive |
|---|---|---|
| Treatment with QUTENZA | Patients with Peripheral Neuropathic Pain Receives: Drug: Qutenza exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in average pain NPRS (Numeric Pain Rating Scale) scores
Measured: From Baseline to mean of all scores recorded between week 2 and week 8 following first treatment
Time to retreatment
From the 1st treatment to the End of Study (The End of Study is defined as the completion of one year of follow-up from the first Qutenza treatment of the last patient enrolled)
Measured: Between 1st & 2nd treatments (up to a maximum of 24 months)
Secondary outcomes (18)
Proportion of patients achieving 30% decrease in average pain NPRS score
Measured: From Baseline to mean of all scores recorded between weeks 2 & 8 following 1st treatment
Proportion of patients achieving 50% decrease in average pain NPRS score
Measured: From Baseline to mean of all scores recorded between weeks 2 & 8 following 1st treatment
Percent change in "average pain" NPRS score
From the 1st treatment to the End of Study (The End of Study is defined as the completion of one year of follow-up from the first Qutenza treatment of the last patient enrolled)
Measured: From baseline to mean of all scores between Week 2 and Week 8 and Weeks 2 and Week 12 following retreatment(s)
Proportion of patients achieving a 30% decrease in their "average pain" NPRS score (maintenance response)
From the 1st treatment to the End of Study (The End of Study is defined as the completion of one year of follow-up from the first Qutenza treatment of the last patient enrolled)
Measured: From Baseline to the mean of all scores between week 2 and week 8 and between week 2 and week 12 following retreatment(s)
Proportion of patients achieving a 50% decrease in their "average pain" NPRS score (maintenance response)
From the 1st treatment to the End of Study (The End of Study is defined as the completion of one year of follow-up from the first Qutenza treatment of the last patient enrolled)
Measured: From Baseline to the mean of all scores between week 2 and week 8 and between week 2 and week 12 following retreatment(s)
Absolute change in "average pain" NPRS score
From the 1st treatment to the End of Study (The End of Study is defined as the completion of one year of follow-up from the first Qutenza treatment of the last patient enrolled)
Measured: From baseline to the average of pain scores assessed between Weeks 2 & 12 following 1st and subsequent treatment(s)
Proportion of patients achieving a 2-point absolute decrease in their "average pain" NPRS score
From the 1st treatment to the End of Study (The End of Study is defined as the completion of one year of follow-up from the first Qutenza treatment of the last patient enrolled)
Measured: From baseline to the average of pain scores assessed between Weeks 2 & 12 following 1st and subsequent treatment(s)
Mean "Average pain" NPRS score
From the 1st treatment to the End of Study (The End of Study is defined as the completion of one year of follow-up from the first Qutenza treatment of the last patient enrolled)
Measured: At each time point following 1st and subsequent treatment(s) (up to a maximum of 24 months)
Time (in days) between successive retreatments
From the 1st treatment to the End of Study (The End of Study is defined as the completion of one year of follow-up from the first Qutenza treatment of the last patient enrolled)
Measured: Between successive retreatments (up to a maximum of 24 months)
Number of QUTENZA patches used with each treatment
Measured: Day 1 of each treatment
Relative change in treatment area size
From the 1st treatment to the End of Study (The End of Study is defined as the completion of one year of follow-up from the first Qutenza treatment of the last patient enrolled)
Measured: At first treatment and each retreatment (up to a maximum of 24 months)
Change in concomitant pain medications
Percentage remaining on opioids, anticonvulsants, antidepressants
Measured: From baseline to End of Study (up to 24 months)
Change in health-related quality of life
Measured by the EQ-5D (Euroqol-5 dimensions) index
Measured: From baseline to End of Study (up to 24 months)
Change in health resource use
Number of contacts with health professionals in prior 4 weeks
Measured: From baseline to End of Study (up to 24 months)
Patient Global Impression of Change
Percentage reporting any degree of improvement. Week 2 after 1st Treatment to End of Study
Measured: At each follow-up after 1st and subsequent treatment(s) (up to a maximum of 24 months)
Patient Self Assessment of Treatment
Week 2 after 1st Treatment to End of Study
Measured: At 12 weeks, 6 months, 9 months, and 12 months after 1st and subsequent retreatment(s)
Change in Work Productivity and Activity Impairment scores
Week 2 after 1st Treatment to End of Study
Measured: Baseline, week 12, 6 months, 9 months, and 12 months after 1st and subsequent treatment(s)
Percentage of patients requiring rescue measures during and after treatment with QUTENZA
Measured: From Baseline to End of Study (up to 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startFeb 2012
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Neuropathic PainStudies 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
- 429 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Company Medical Expert, Study director, Astellas Pharma Europe Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01737294
- Sponsor's protocol ID
- QTZ-EC-0003
- Acronym
- ASCEND
- Status last verified
- Oct 2014
- First submitted
- 22 Oct 2012
- Last updated
- 6 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Mankowski C, Poole CD, Ernault E, Thomas R, Berni E, Currie CJ, Treadwell C, Calvo JI, Plastira C, Zafeiropoulou E, Odeyemi I. Effectiveness of the capsaicin 8% patch in the management of peripheral neuropathic pain in European clinical practice: the ASCEND study. BMC Neurol. 2017 Apr 21;17(1):80. doi: 10.1186/s12883-017-0836-z.
PubMed 28431564
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of QUTENZA™ in Standard Clinical Practice: a Phase IV, Multicentre, European Non-interventional Study
- ClinicalTrials.gov ID
- NCT01737294
- Acronym / sponsor ID
- ASCEND / QTZ-EC-0003
- Conditions
- Peripheral Neuropathic Pain
- Keywords
- Phase IV, Peripheral Neuropathic Pain, QUTENZA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 429 participants (actual)
- Lead sponsor
- Astellas Pharma Europe Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 29 Nov 2012 (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.
This non-interventional study will evaluate the efficacy, tolerability, health related quality of life and use of health resources associated with QUTENZA treatment when QUTENZA is used in standard clinical practice.
The patient's primary diagnosis of peripheral neuropathic pain (PNP) will be classified into subtypes: post-herpetic neuralgia (PHN); HIV-associated neuropathy (HIV-AN); neuropathic back pain; cancer-related neuropathic pain; post-operative \& post-traumatic neuropathic pain; and 'other' neuropathies.
Detailed description
A detailed medical history will be taken, with particular emphasis on the primary PNP diagnosis. In addition to all current neuropathic pain medications, all previous therapies (pharmacological and surgical) for PNP from the point of primary diagnosis will be documented.
QUTENZA treatments may be repeated up to every 90 days, in line with the Summary of Product Characteristics document (SPC) as determined by the persistence or return of pain.
Patients who have not required treatment for 365 days or longer may re-enter a treatment cycle if their treating physician decides to retreat them with QUTENZA in the course of standard clinical management.
The duration of participation for each patient will be at least 12 months following first QUTENZA treatment.
Short questionnaires will be completed by the investigator whilst in contact with the patient (either in person or by telephone) at the following time points: 1) Screening prior to the first QUTENZA treatment; 2) at each QUTENZA treatment visit; 3) 2 weeks, 8 weeks following the first QUTENZA treatment 4) 12 weeks following each QUTENZA treatment; 5) any additional contact with the patient outside the protocol schedule.
For patients not returning for retreatment with QUTENZA within any of 6 months, 9 months, and 1 year of their previous QUTENZA treatment further follow-up questionnaires will be completed.
End of study (EoS) is defined as one year after the last patient enrolled receives their first QUTENZA treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with QUTENZA | – | Drug: Qutenza exposurePatients with Peripheral Neuropathic Pain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving QUTENZA for PNP in routine clinical practice
Key inclusion criteria (2 listed)
- 1. The investigator has decided to treat the patient with QUTENZA as part of provision of standard care for the treatment of peripheral neuropathic pain in non-diabetic adults either alone or in combination with other medicinal products for pain
- 2. The patient is willing and able to comply with protocol requirements for the duration of study participation
Key exclusion criteria (8 listed)
- 1. The neuropathic painful areas are located only on the face, above the hairline of the scalp, and/or in proximity to mucous membranes
- 2. The patient has a history of Type I or Type II diabetes mellitus
- 3. The patient has a diagnosis of any major psychiatric disorder or evidence of cognitive impairment including dementia that, in the opinion of the investigator, may interfere with patient's ability to complete study evaluations
- 4. The patient has received any prior treatment with QUTENZA patches, including blinded patches administered as part of a clinical trial
- 5. The patient has hypersensitivity to capsaicin (i.e. chilli peppers or over-the-counter [OTC] capsaicin products), any QUTENZA excipients or adhesives, or local anesthetics
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 |
|---|---|---|
| Qutenza exposureAlso: CapsaicinCutaneous patch | Drug | Treatment with QUTENZA |
Primary outcome
Percent change in average pain NPRS (Numeric Pain Rating Scale) scores
Time frame: From Baseline to mean of all scores recorded between week 2 and week 8 following first treatment
Time to retreatment
Time frame: Between 1st & 2nd treatments (up to a maximum of 24 months)
From the 1st treatment to the End of Study (The End of Study is defined as the completion of one year of follow-up from the first Qutenza treatment of the last patient enrolled)
18 secondary outcomes
Proportion of patients achieving 30% decrease in average pain NPRS score
Time frame: From Baseline to mean of all scores recorded between weeks 2 & 8 following 1st treatment
Proportion of patients achieving 50% decrease in average pain NPRS score
Time frame: From Baseline to mean of all scores recorded between weeks 2 & 8 following 1st treatment
Percent change in "average pain" NPRS score
Time frame: From baseline to mean of all scores between Week 2 and Week 8 and Weeks 2 and Week 12 following retreatment(s)
Proportion of patients achieving a 30% decrease in their "average pain" NPRS score (maintenance response)
Time frame: From Baseline to the mean of all scores between week 2 and week 8 and between week 2 and week 12 following retreatment(s)
Proportion of patients achieving a 50% decrease in their "average pain" NPRS score (maintenance response)
Time frame: From Baseline to the mean of all scores between week 2 and week 8 and between week 2 and week 12 following retreatment(s)
Absolute change in "average pain" NPRS score
Time frame: From baseline to the average of pain scores assessed between Weeks 2 & 12 following 1st and subsequent treatment(s)
Proportion of patients achieving a 2-point absolute decrease in their "average pain" NPRS score
Time frame: From baseline to the average of pain scores assessed between Weeks 2 & 12 following 1st and subsequent treatment(s)
Mean "Average pain" NPRS score
Time frame: At each time point following 1st and subsequent treatment(s) (up to a maximum of 24 months)
Time (in days) between successive retreatments
Time frame: Between successive retreatments (up to a maximum of 24 months)
Number of QUTENZA patches used with each treatment
Time frame: Day 1 of each treatment
Relative change in treatment area size
Time frame: At first treatment and each retreatment (up to a maximum of 24 months)
Change in concomitant pain medications
Time frame: From baseline to End of Study (up to 24 months)
Change in health-related quality of life
Time frame: From baseline to End of Study (up to 24 months)
Change in health resource use
Time frame: From baseline to End of Study (up to 24 months)
Patient Global Impression of Change
Time frame: At each follow-up after 1st and subsequent treatment(s) (up to a maximum of 24 months)
Patient Self Assessment of Treatment
Time frame: At 12 weeks, 6 months, 9 months, and 12 months after 1st and subsequent retreatment(s)
Change in Work Productivity and Activity Impairment scores
Time frame: Baseline, week 12, 6 months, 9 months, and 12 months after 1st and subsequent treatment(s)
Percentage of patients requiring rescue measures during and after treatment with QUTENZA
Time frame: From Baseline to End of Study (up to 24 months)
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 6 Oct 2014.
- Derived from this study: PubMed 28431564Mankowski C, Poole CD, Ernault E, Thomas R, Berni E, Currie CJ, Treadwell C, Calvo JI, Plastira C, Zafeiropoulou E, Odeyemi I. Effectiveness of the capsaicin 8% patch in the management of peripheral neuropathic pain in European clinical practice: the ASCEND study. BMC Neurol. 2017 Apr 21;17(1):80. doi: 10.1186/s12883-017-0836-z.
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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.
Company Medical Expert study director
Astellas Pharma Europe Ltd.
50 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Neuropathic Pain, run by Astellas Pharma Europe Ltd. at 50 sites in 7 countries.
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 2 inclusion and 8 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 6 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in Greece, Portugal, Austria, Italy, Spain and 2 more countries. 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?
Percent change in average pain NPRS (Numeric Pain Rating Scale) scores (time frame: From Baseline to mean of all scores recorded between week 2 and week 8 following first treatment). The study lists 2 primary outcomes in all. 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 NCT01737294, which also lists 1 linked publication.
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 6 Oct 2014.