Trazodone in Painful Diabetic Neuropathy

September 27, 2018 updated by: Aziende Chimiche Riunite Angelini Francesco S.p.A

Efficacy and Safety of Low Doses of Trazodone in Patients Affected by Painful Diabetic Neuropathy: Randomized, Controlled, Pilot Study.

The aim of the study is to collect preliminary information on the effect of low doses of trazodone on pain intensity in patients with painful diabetic neuropathy and to evaluate the neuropathic pain symptoms, anxiety, sleep, quality of life, safety and tolerability.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a randomized, double-blind, placebo controlled, double-dummy, dose finding, parallel group, multicentre, international, prospective, pilot study.

The present study is planned to assess the efficacy and the safety of an 8-week treatment period with low doses of trazodone (30 mg daily or 60 mg total daily, respectively) administered to patients affected by painful diabetic neuropathy.

Gabapentin will be administered together with the investigational drug in open label conditions in order to assure an effective pharmacological treatment to all patients. A slow titration of gabapentin will be applied in this trial in order to control possible side effects when co-administered with trazodone.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
142

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Chocen, Czechia, 565 01
        • NEUROHK s.r.o.
      • Litomerice, Czechia, 412 01
        • Litnea s.r.o. Neurologicka ambulance
      • Litomysl, Czechia, 570 01
        • Neurosanatio s.r.o.
      • Ostrava, Czechia, 710 00
        • MP-neuro s.r.o. Poliklinika Modry pavilon
      • Pardubice, Czechia, 532 03
        • Nemocnice Pardubického kraje a.s. Pardubická nemocnice Neurologická klinika
      • Praha 4, Czechia, 149 00
        • Diabetologická ambulance Milan Kvapil s.r.o.
      • Rychnov nad Knežnou, Czechia, 516 01
        • Vestra Clinics s.r.o.
  • Hungary
      • Budapest, Hungary, 1027
        • Budai Irgalmasrendi Korhaz Belgyógyászati Centrum
      • Budapest, Hungary, 1083
        • Semmelweis Egyetem AOK I. sz. Belgyogyaszati Klinika
      • Eger, Hungary, 3300
        • Markhot Ferenc Oktatokorhaz es Rendelointezet Diabetesz Gondozo
      • Gyula, Hungary, 5700
        • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz I. sz. Belgyogyaszati Osztaly
      • Kecskemet, Hungary, 6000
        • Bacs-Kiskun Megyei Korhaz II. sz. Belgyogyaszati Osztaly
      • Szeged, Hungary, 6720
        • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont I. Sz. Belgyogyaszati Klinika
  • Poland
      • Katowice, Poland, 40-282
        • Silmedic Sp. z o.o.
      • Katowice, Poland, 40-648
        • Pro Familia Altera Sp. z o.o.
      • Lublin, Poland, 20-064
        • NZOZ Neuromed M. i M. Nastaj Sp. P.
      • Sochaczew, Poland, 96-500
        • RCMed Oddział Sochaczew
      • Torun, Poland, 87-100
        • Jeka Sławomir Niepubliczny Zakład Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna
      • Warszawa, Poland, 00-465
        • NBR Polska Tomasz Klodawski
      • Warszawa, Poland, 00-660
        • Medycyna Kliniczna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male and female patient of any ethnic origin between 18 and 75 years of age (limits included).
  2. Patient with painful diabetic symmetric polyneuropathy manifesting with distally distributed neuropathic pain.
  3. Stable glycaemic control with a value of HbA1c ≤ 10% at Screening Visit.
  4. Pain persisting for at least 3 months.
  5. Neuropathic pain confirmed by DN4 score ≥ 4 at Screening Visit.
  6. BPI-SF 24-hour average pain score (item 5) ≥ 4 at Screening Visit and Baseline Visit.
  7. Patient who is currently not receiving treatment for diabetic neuropathic pain or patient who is receiving treatment, with drug/s other than gabapentin, and have completed the required washout.
  8. Women of childbearing potential must have a negative pregnancy test at Screening Visit and have to agree not to start a pregnancy from the signature of the informed consent up to thirty days after the last administration of the investigational product, using an appropriate birth control method, such as combined estrogen and progestogen containing hormonal contraception (e.g. oral, intravaginal, transdermal), progestogen-only hormonal contraception (e.g. oral, injectable, implantable), intrauterine device (IUD) or intrauterine hormone- releasing system (IUS) in combination with male condom, bilateral tubal occlusion, vasectomised partner, sexual abstinence.
  9. Legally capable to give their consent to participate in the study and available to sign and date the written informed consent.

Exclusion Criteria:

  1. Known hypersensitivity to trazodone or gabapentin or their excipients.
  2. Other forms of neuropathic pain or non-neuropathic pain (included but not limited to peripheral arterial disease, radiculopathy, mononeuropathy, proximal motor neuropathy, post-operative pain, etc).
  3. Concomitant treatment with other medications for pain management.
  4. Concomitant treatment with potent CYP3A4 inhibitors (e.g. ketoconazole, ritonavir, indinavir) or drugs known to prolong QT interval.
  5. Use of trazodone or gabapentin in the previous 3 months.
  6. Clinically significant abnormalities on physical examination, vital signs, ECG, laboratory tests at Screening Visit that in the opinion of Investigator would compromise patient's participation in the study.
  7. Active foot ulcer or previous major limb amputation.
  8. Myocardial infarction or angioplasty or by-pass graft procedures within the past 6 months.
  9. Patient with increased risk of Torsade de Pointes (e.g. family history of long QT syndrome) or QTcF value higher than 450 msec (male) and QTcF value higher than 470 msec (female) at Screening Visit.
  10. Transient ischemic attack or cerebral vascular accident within the past 6 months.
  11. GFR value < 60 ml/min calculated with MDRD formula.
  12. Significant liver disease, defined as known active hepatitis or elevated liver enzymes over 3 fold the upper normal limit of laboratory normal ranges.
  13. Patient with latent or known hereditary problems of galactose intolerance or the Lapp lactase deficiency or glucose-galactose malabsorption.
  14. Positive urine drug screen for CNS active drugs (cocaine, opioids, amphetamines and cannabinoids) a Screening Visit.
  15. Positive present history of glaucoma.
  16. Hyperthyroidism, even if pharmacologically corrected.
  17. Significant mental disorders.
  18. History of seizure events other than a single childhood febrile seizure.
  19. History of alcohol or psychoactive substance abuse or addiction.
  20. Patient suffering from adrenal hypofunction (e.g. Addison's disease).
  21. Women during pregnancy or lactation period.
  22. Inability to comply with the protocol requirements, instructions or study-related restrictions (e.g. uncooperative attitude, inability to return for study-visits, improbability of completing the clinical study, etc).
  23. Subject involved in the conduct of the study (e.g. Investigator or his/her deputy, first grade relatives, pharmacist, assistant or other personnel, etc).
  24. Participation to an interventional clinical trial within 3 months prior to Screening Visit.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group 1
Trazodone 20 mg
Drug: Trazodone 20 mg

Oral administration of trazodone 20 mg (corresponding to 10 drops of trazodone hydrochloride 6% oral solution), three times a day, for 8 weeks. Trazodone total daily dose: 60 mg.

After the 8-week treatment period, patients will receive trazodone 10 mg (corresponding to 5 drops of trazodone hydrochloride 6% oral solution) three times a day for 1-week tapering period in double blind conditions.

Other Names:
  • Trittico®
Experimental: Group 2
Trazodone 10 mg
Drug: Trazodone 10 mg

Oral administration of trazodone 10 mg (corresponding to 5 drops of trazodone hydrochloride 6% oral solution), three times a day, for 8 weeks. Trazodone total daily dose: 30 mg.

In order to maintain the study double-blind conditions,patients randomized in this group will be co-administered with placebo oral solution (5 drops).

After the 8-week treatment period, patients will receive placebo oral solution three times a day for 1-week tapering period in double blind conditions.

Other Names:
  • Trittico®
Placebo Comparator: Group 3
Placebo
Drug: Placebo

Oral administration of placebo oral solution (10 drops) three times a day, for 8-week treatment.

After the 8-week treatment period, patients will receive placebo oral solution three times a day for 1-week tapering period in double blind conditions.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change of item 5 score in Brief Pain Inventory Short Form (BPI-SF) scale
Time Frame: Baseline - Day 56
Change from baseline of item 5 score in BPI-SF numering scale after 56 days.
Baseline - Day 56

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change of item 5 score in Brief Pain Inventory Short Form (BPI-SF) scale
Time Frame: Baseline - Days 7, 14, 21, 28, 35, 42, 49, 63
Change from baseline of item 5 score in BPI-SF numering scale after 7, 14, 21, 28, 35, 42, 49 and 63 days.
Baseline - Days 7, 14, 21, 28, 35, 42, 49, 63
Change of item 3 score in Brief Pain Inventory Short Form (BPI-SF) scale
Time Frame: Baseline - Days 7, 14, 21, 28, 35, 42, 49, 56 and 63.
Change from baseline of item 3 score in BPI-SF numering scale after 7, 14, 21, 28, 35, 42, 49, 56 and 63 days.
Baseline - Days 7, 14, 21, 28, 35, 42, 49, 56 and 63.
Change of item 4 score in Brief Pain Inventory Short Form (BPI-SF) scale
Time Frame: Baseline - Days 7, 14, 21, 28, 35, 42, 49, 56 and 63.
Change from baseline of item 4 score in BPI-SF numering scale after 7, 14, 21, 28, 35, 42, 49, 56 and 63 days.
Baseline - Days 7, 14, 21, 28, 35, 42, 49, 56 and 63.
Change of item 5 score in Brief Pain Inventory Short Form (BPI-SF) scale
Time Frame: Baseline - Days 7, 14, 21, 28, 35, 42, 49, 56 and 63.
Change from baseline of item 5 score in BPI-SF numering scale after 7, 14, 21, 28, 35, 42, 49, 56 and 63 days.
Baseline - Days 7, 14, 21, 28, 35, 42, 49, 56 and 63.
Change of item 6 score in Brief Pain Inventory Short Form (BPI-SF) scale
Time Frame: Baseline - Days 7, 14, 21, 28, 35, 42, 49, 56 and 63.
Change from baseline of item 6 score in BPI-SF numering scale after 7, 14, 21, 28, 35, 42, 49, 56 and 63 days.
Baseline - Days 7, 14, 21, 28, 35, 42, 49, 56 and 63.
Change of item 8 score in Brief Pain Inventory Short Form (BPI-SF) scale
Time Frame: Baseline - Days 7, 14, 21, 28, 35, 42, 49, 56 and 63.
Change from baseline of item 8 score in BPI-SF numering scale after 7, 14, 21, 28, 35, 42, 49, 56 and 63 days.
Baseline - Days 7, 14, 21, 28, 35, 42, 49, 56 and 63.
Change of item 9 score in Brief Pain Inventory Short Form (BPI-SF) scale
Time Frame: Baseline - Days 7, 14, 21, 28, 35, 42, 49, 56 and 63.
Change from baseline of item 9 score in BPI-SF numering scale after 7, 14, 21, 28, 35, 42, 49, 56 and 63 days.
Baseline - Days 7, 14, 21, 28, 35, 42, 49, 56 and 63.
Change in Neuropathic Pain Symptom Inventory (NPSI) scale
Time Frame: Baseline - Days 7, 14, 21, 28, 35, 42, 49, 56 and 63.
Change from baseline of total score in NPSI scale after 7, 14, 21, 28, 35, 42, 49, 56 and 63 days.
Baseline - Days 7, 14, 21, 28, 35, 42, 49, 56 and 63.
Change in 36-item Short-Form Health Survey (SF-36)
Time Frame: Baseline - Day 56
Change from baseline of SF-36 after 56 days.
Baseline - Day 56
Change in Hamilton Anxiety Rating Scale (HAM-A)
Time Frame: Baseline - Days 7, 14, 21, 28, 35, 42, 49, 56 and 63.
Change from baseline of total score in HAM-A scale after 7, 14, 21, 28, 35, 42, 49, 56 and 63 days.
Baseline - Days 7, 14, 21, 28, 35, 42, 49, 56 and 63.
Patient Global Impression of Change (PGIC)
Time Frame: Days 7, 14, 21, 28, 35, 42, 49, 56 and 63.
Assessment by patient of the overall efficacy and tolerability by PGIC after 7, 14, 21, 28, 35, 42, 49, 56 and 63 days
Days 7, 14, 21, 28, 35, 42, 49, 56 and 63.
Change in Leeds Sleep Evaluation Questionnaire (LSEQ)
Time Frame: Baseline - Days 7, 14, 21, 28, 35, 42, 49, 56 and 63.
Change from baseline in LSEQ after 7, 14, 21, 28, 35, 42, 49, 56 and 63 days.
Baseline - Days 7, 14, 21, 28, 35, 42, 49, 56 and 63.
Frequency of treatment-related adverse events
Time Frame: 9 weeks
Monitoring of the frequency of adverse events, physical examination, vital signs, ECG, laboratory analyses
9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aziende Chimiche Riunite Angelini Francesco S.p.A

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Chiltern International Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 16, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 9, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 9, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 28, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 039(B)PO16143
  • 2016-002772-27 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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