A Study to Evaluate the Long-term Safety of Repeated QUTENZA Administration for Treatment of Pain Caused by Nerve Damage in Diabetic Patients

NCT01478607 | Completed Phase 3

• 2 other identifiers: E05-CL-30022009-016458-42
• Study Type: interventional
• Target: 468
• Locations: 11 countries
• Sites: 64

Brief Summary

The purpose of the study is to assess the safety of repeated applications of QUTENZA in reducing pain intensity in subjects who have peripheral neuropathic pain due to diabetes.

Conditions

Painful Diabetic Peripheral Neuropathy (PDPN)

Keywords

Painful Diabetic Peripheral Neuropathy; Qutenza

Outcome Measures

Primary Outcomes (1)

• Percentage change in health related quality of life (HRQOL) total score as assessed by the disease specific Norfolk scale

  Baseline till endpoint (discontinuation or End of Study visit) (up to 64 weeks)

Secondary Outcomes (12)

• Neurological function as assessed by the Utah Early Neuropathy Scale (UENS) and sensory testing

  Baseline till End of Study (up to 64 weeks)

• Tolerability of patch application by dermal assessment

  Screening till Last visit when QUTENZA patch is applied (up to 53 weeks)

• Tolerability of patch application by "pain now" Numeric Pain Rating Scale (NPRS) scores after patch application

  Baseline till Last visit when QUTENZA patch is applied (up to 52 weeks)

• Tolerability of patch application by rescue medication use

  Days 1 through 5 after each patch application

• Adverse Events and serious adverse Events

  Screening visit through End of study visit (up to 65 weeks)

Study Arms (3)

1. Qutenza 30 minutes + SOC

EXPERIMENTAL

Drug: QUTENZA

2. Qutenza 60 minutes + SOC

EXPERIMENTAL

Drug: QUTENZA

3. SOC

NO INTERVENTION

Subjects randomized to this group will receive treatment optimized for them on an individual basis. The investigator will be free to provide whatever pharmacological or other treatment is considered optimal for management of the subject's pain.

Interventions

QUTENZA DRUG

A Qutenza (8% capsaicin) patch will be applied to identified painful areas for 30 minutes (Arm 1) or 60 minutes (Arm 2).

Also known as: Capsaisin

1. Qutenza 30 minutes + SOC; 2. Qutenza 60 minutes + SOC

Eligibility Criteria

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

You may qualify if:

• Diagnosis of painful, distal, symmetrical, sensorimotor polyneuropathy which is due to diabetes
• Stable glycemic control for at least 6 months prior to screening visit
• Average Numeric Pain Rating Scale (NPRS) score over the last 24 hours of \>4 at the screening and the baseline visit

You may not qualify if:

• Primary pain associated with PDPN in the ankles or above
• Pain that could not be clearly differentiated from, or conditions that might interfere with, the assessment of PDPN
• Significant pain (moderate or above) of an etiology other than PDPN, that may interfere with judging PDPN-related pain
• Female subjects of childbearing potential must have a negative serum or urine pregnancy test at enrollment and must agree to maintain highly effective birth control during the study.
• Hypersensitivity to capsaicin (i.e., chili peppers or over-the-counter \[OTC\] capsaicin products), any QUTENZA excipients, Eutectic Mixture of Local Anesthetics( EMLA) ingredients or adhesives

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (64)

Site: 601

Bonheiden, 2820, Belgium

Location

Site: 903

Beroun, 26601, Czechia

Location

Site: 910

Brno, 60200, Czechia

Location

Site: 908

Choceň, 56501, Czechia

Location

Site: 911

Litoměřice, 41201, Czechia

Location

Site: 906

Ostrava, 71000, Czechia

Location

Site: 904

Polička, 57201, Czechia

Location

Site: 901

Prague, 14000, Czechia

Location

Site: 902

Přerov, 75003, Czechia

Location

Site: 909

Rychnov nad Kněžnou, 51601, Czechia

Location

Site: 207

Bron, 69677, France

Location

Site: 202

Paris, 75004, France

Location

Site: 201

Pierre-Bénite, 69495, France

Location

Site: 206

Toulouse, 31059, France

Location

Site: 508

Chiemsee, 83209, Germany

Location

Site: 509

Cologne, 50937, Germany

Location

Site: 502

Dresden, 1307, Germany

Location

Site: 501

Falkensee, 14612, Germany

Location

Site: 514

Frankfurt, 60311, Germany

Location

Site: 507

Hamburg, 22177, Germany

Location

Site: 505

Leipzig, 04109, Germany

Location

Site: 506

Münster, 48145, Germany

Location

Site: 512

Wangen, 88239, Germany

Location

Site: 404

Milan, 20162, Italy

Location

Site: 401

Roma, 00133, Italy

Location

Site: 651

Utrecht, 3584 CX, Netherlands

Location

Site: 965

Bialystok, 15435, Poland

Location

Site: 961

Bydgoszcz, 85822, Poland

Location

Site: 957

Elblag, 82300, Poland

Location

Site: 958

Gdynia, 81049, Poland

Location

Site: 954

Katowice, 40954, Poland

Location

Site: 964

Krakow, 31530, Poland

Location

Site: 951

Lodz, 90153, Poland

Location

Site: 966

Lubin, 59300, Poland

Location

Site: 953

Poznan, 61655, Poland

Location

Site: 959

Torun, 87100, Poland

Location

Site: 960

Warsaw, 1868, Poland

Location

Site: 714

Kemerovo, 150062, Russia

Location

Site: 703

Saint Petersburg, 191015, Russia

Location

Site: 716

Saint Petersburg, 194358, Russia

Location

Site: 704

Saint Petersburg, 79117120826, Russia

Location

Site: 706

Saint Petersburg, 79117778999, Russia

Location

Site: 708

Samara, 79117778999, Russia

Location

Site: 709

Saratov, 79117120826, Russia

Location

Site: 713

Tomsk, 79117778999, Russia

Location

Site: 711

Yaroslavl, 79117778999, Russia

Location

Site: 303

Valencia, 46010, Spain

Location

Site: 304

Valencia, 46014, Spain

Location

Site: 305

Valladolid, 47012, Spain

Location

Site: 808

Chernihiv, 14034, Ukraine

Location

Site: 803

Kharkiv, 61037, Ukraine

Location

Site: 812

Kvuv, 79010, Ukraine

Location

Site: 805

Kyiv, 2091, Ukraine

Location

Site: 807

Kyiv, 4053, Ukraine

Location

Site: 806

Kyiv, 4114, Ukraine

Location

Site: 810

Lviv, 79010, Ukraine

Location

Site: 802

Mykolayiv, 54003, Ukraine

Location

Site: 801

Odesa, 65009, Ukraine

Location

Site: 813

Vinnitsa, 21010, Ukraine

Location

Site: 815

Zaporizhzhya, 69001, Ukraine

Location

Site: 102

Chorley, PR7 1PP, United Kingdom

Location

Site: 103

Liverpool, L7 8XP, United Kingdom

Location

Site: 104

Poole, BH15 2JB, United Kingdom

Location

Site: 101

Rugby, CV22 5PX, United Kingdom

Location

Related Publications (1)

• Vinik AI, Perrot S, Vinik EJ, Pazdera L, Jacobs H, Stoker M, Long SK, Snijder RJ, van der Stoep M, Ortega E, Katz N. Capsaicin 8% patch repeat treatment plus standard of care (SOC) versus SOC alone in painful diabetic peripheral neuropathy: a randomised, 52-week, open-label, safety study. BMC Neurol. 2016 Dec 6;16(1):251. doi: 10.1186/s12883-016-0752-7.

  PMID: 27919222 DERIVED

Related Links

• Link to results on EudraCT
• Link to results on Astellas Clinical Study Results Web site

MeSH Terms

Interventions

Capsaicin

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Study Officials

• Senior Clinical Study Manager

  Astellas Pharma Europe B.V.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2011
• First Posted: November 23, 2011
• Study Start: November 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: October 14, 2015

Record last verified: 2015-10

Locations

FR (4); CZ (9); NL (1); GB (4); RU (9); BE (1); ES (3); UA (11); PL (11); DE (9); IT (2)