Painful Diabetic NeuropathyPhase 2NCT03202979
Trazodone in Painful Diabetic Neuropathy
A Phase 2 study testing Trazodone 20 mg and Trazodone 10 mg in people with Painful Diabetic Neuropathy, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 20 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Painful Diabetic Neuropathy
- What is being tested?
- Trazodone 20 mg and Trazodone 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- 20 sitesin 3 countries
- Study dates
- 16 May 2017to 9 Aug 2018
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patient of any ethnic origin between 18 and 75 years of age (limits included).
- Patient with painful diabetic symmetric polyneuropathy manifesting with distally distributed neuropathic pain.
- Stable glycaemic control with a value of HbA1c ≤ 10% at Screening Visit.
- Pain persisting for at least 3 months.
- Neuropathic pain confirmed by DN4 score ≥ 4 at Screening Visit.
- BPI-SF 24-hour average pain score (item 5) ≥ 4 at Screening Visit and Baseline Visit.
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- 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.
- 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.
- Legally capable to give their consent to participate in the study and available to sign and date the written informed consent.
Who cannot join
- Known hypersensitivity to trazodone or gabapentin or their excipients.
- 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).
- Concomitant treatment with other medications for pain management.
- Concomitant treatment with potent CYP3A4 inhibitors (e.g. ketoconazole, ritonavir, indinavir) or drugs known to prolong QT interval.
- Use of trazodone or gabapentin in the previous 3 months.
- 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.
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- Active foot ulcer or previous major limb amputation.
- Myocardial infarction or angioplasty or by-pass graft procedures within the past 6 months.
- 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.
- Transient ischemic attack or cerebral vascular accident within the past 6 months.
- GFR value < 60 ml/min calculated with MDRD formula.
- Significant liver disease, defined as known active hepatitis or elevated liver enzymes over 3 fold the upper normal limit of laboratory normal ranges.
- Patient with latent or known hereditary problems of galactose intolerance or the Lapp lactase deficiency or glucose-galactose malabsorption.
- Positive urine drug screen for CNS active drugs (cocaine, opioids, amphetamines and cannabinoids) a Screening Visit.
- Positive present history of glaucoma.
- Hyperthyroidism, even if pharmacologically corrected.
- Significant mental disorders.
- History of seizure events other than a single childhood febrile seizure.
- History of alcohol or psychoactive substance abuse or addiction.
- Patient suffering from adrenal hypofunction (e.g. Addison's disease).
- Women during pregnancy or lactation period.
- 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).
- Subject involved in the conduct of the study (e.g. Investigator or his/her deputy, first grade relatives, pharmacist, assistant or other personnel, etc).
- Participation to an interventional clinical trial within 3 months prior to Screening Visit.
Trial locations and contacts
20 sites in 3 countries.
20 sites in 3 countries
Czechia7 sites
NEUROHK s.r.o.
Choceň, 565 01
Litnea s.r.o. Neurologicka ambulance
Litoměřice, 412 01
Neurosanatio s.r.o.
Litomyšl, 570 01
MP-neuro s.r.o. Poliklinika Modry pavilon
Ostrava, 710 00
Nemocnice Pardubickeho kraje a.s. Pardubicka nemocnice Neurologická klinika
Pardubice, 532 03
Diabetologicka ambulance Milan Kvapil s.r.o.
Prague, 149 00
Vestra Clinics s.r.o.
Rychnov Nad Knežnou, 516 01
Poland7 sites
Silmedic Sp. z o.o.
Katowice, 40-282
Pro Familia Altera Sp. z o.o.
Katowice, 40-648
NZOZ Neuromed M. i M. Nastaj Sp. P.
Lublin, 20-064
RCMed Oddział Sochaczew
Sochaczew, 96-500
Jeka Sławomir Niepubliczny Zakład Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna
Torun, 87-100
NBR Polska Tomasz Klodawski
Warsaw, 00-465
Medycyna Kliniczna
Warsaw, 00-660
Hungary6 sites
Budai Irgalmasrendi Korhaz Belgyógyászati Centrum
Budapest, 1027
Semmelweis Egyetem AOK I. sz. Belgyogyaszati Klinika
Budapest, 1083
Markhot Ferenc Oktatokorhaz es Rendelointezet Diabetesz Gondozo
Eger, 3300
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz I. sz. Belgyogyaszati Osztaly
Gyula, 5700
Bacs-Kiskun Megyei Korhaz II. sz. Belgyogyaszati Osztaly
Kecskemét, 6000
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont I. Sz. Belgyogyaszati Klinika
Szeged, 6720
About this study
Official title: 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.
Read the 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.
- Conditions
- Painful Diabetic Neuropathy
- Being tested
- Trazodone 20 mg, Trazodone 10 mg, Placebo
- Keywords
- Trazodone, Placebo, Gabapentin, Neuropathic pain
- Medical subject headings
- Diabetic Neuropathies, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trazodone 20 mgDrug
Also called Trittico®
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.
Trazodone 10 mgDrug
Also called Trittico®
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Trazodone 20 mg Receives: Drug: Trazodone 20 mg |
| Group 2 | Experimental | Trazodone 10 mg Receives: Drug: Trazodone 10 mg |
| Group 3 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of item 5 score in Brief Pain Inventory Short Form (BPI-SF) scale
Change from baseline of item 5 score in BPI-SF numering scale after 56 days.
Measured: Baseline - Day 56
Secondary outcomes (13)
Change of item 5 score in Brief Pain Inventory Short Form (BPI-SF) scale
Change from baseline of item 5 score in BPI-SF numering scale after 7, 14, 21, 28, 35, 42, 49 and 63 days.
Measured: Baseline - Days 7, 14, 21, 28, 35, 42, 49, 63
Change of item 3 score in Brief Pain Inventory Short Form (BPI-SF) scale
Change from baseline of item 3 score in BPI-SF numering scale after 7, 14, 21, 28, 35, 42, 49, 56 and 63 days.
Measured: 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
Change from baseline of item 4 score in BPI-SF numering scale after 7, 14, 21, 28, 35, 42, 49, 56 and 63 days.
Measured: 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
Change from baseline of item 5 score in BPI-SF numering scale after 7, 14, 21, 28, 35, 42, 49, 56 and 63 days.
Measured: 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
Change from baseline of item 6 score in BPI-SF numering scale after 7, 14, 21, 28, 35, 42, 49, 56 and 63 days.
Measured: 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
Change from baseline of item 8 score in BPI-SF numering scale after 7, 14, 21, 28, 35, 42, 49, 56 and 63 days.
Measured: 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
Change from baseline of item 9 score in BPI-SF numering scale after 7, 14, 21, 28, 35, 42, 49, 56 and 63 days.
Measured: Baseline - Days 7, 14, 21, 28, 35, 42, 49, 56 and 63.
Change in Neuropathic Pain Symptom Inventory (NPSI) scale
Change from baseline of total score in NPSI scale after 7, 14, 21, 28, 35, 42, 49, 56 and 63 days.
Measured: Baseline - Days 7, 14, 21, 28, 35, 42, 49, 56 and 63.
Change in 36-item Short-Form Health Survey (SF-36)
Change from baseline of SF-36 after 56 days.
Measured: Baseline - Day 56
Change in Hamilton Anxiety Rating Scale (HAM-A)
Change from baseline of total score in HAM-A scale after 7, 14, 21, 28, 35, 42, 49, 56 and 63 days.
Measured: Baseline - Days 7, 14, 21, 28, 35, 42, 49, 56 and 63.
Patient Global Impression of Change (PGIC)
Assessment by patient of the overall efficacy and tolerability by PGIC after 7, 14, 21, 28, 35, 42, 49, 56 and 63 days
Measured: Days 7, 14, 21, 28, 35, 42, 49, 56 and 63.
Change in Leeds Sleep Evaluation Questionnaire (LSEQ)
Change from baseline in LSEQ after 7, 14, 21, 28, 35, 42, 49, 56 and 63 days.
Measured: Baseline - Days 7, 14, 21, 28, 35, 42, 49, 56 and 63.
Frequency of treatment-related adverse events
Monitoring of the frequency of adverse events, physical examination, vital signs, ECG, laboratory analyses
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start16 May 2017
- Primary completion9 Aug 2018
- Study completion9 Aug 2018
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 Painful Diabetic NeuropathyStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, placebo controlled, double-dummy, dose finding, multicentre, international, prospective, pilot study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chiltern International Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03202979
- Sponsor's protocol ID
- 039(B)PO16143
- Other IDs
- 2016-002772-27, 2016
- Status last verified
- Sep 2018
- First submitted
- 23 Jun 2017
- Last updated
- 28 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lipone P, Ehler E, Nastaj M, Palka-Kisielowska I, Cruccu G, Truini A, Di Loreto G, Del Vecchio A, Pochiero I, Comandini A, Calisti F, Cattaneo A. Efficacy and Safety of Low Doses of Trazodone in Patients Affected by Painful Diabetic Neuropathy and Treated with Gabapentin: A Randomized Controlled Pilot Study. CNS Drugs. 2020 Nov;34(11):1177-1189. doi: 10.1007/s40263-020-00760-2.
PubMed 32936427
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Low Doses of Trazodone in Patients Affected by Painful Diabetic Neuropathy: Randomized, Controlled, Pilot Study.
- ClinicalTrials.gov ID
- NCT03202979
- Acronym / sponsor ID
- 039(B)PO16143
- Conditions
- Painful Diabetic Neuropathy
- Keywords
- Trazodone, Placebo, Gabapentin, Neuropathic pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.AIndustry (pharma, biotech, devices)
- Collaborators
- Chiltern International Inc.
- Study start
- 16 May 2017 (actual)
- Primary completion
- 9 Aug 2018 (actual)
- Study completion
- 9 Aug 2018 (actual)
- First posted
- 29 Jun 2017 (actual)
- 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Double-blind, placebo controlled, double-dummy, dose finding, multicentre, international, prospective, pilot study.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Trazodone 20 mgTrazodone 20 mg |
| Group 2 | Experimental | Drug: Trazodone 10 mgTrazodone 10 mg |
| Group 3 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male and female patient of any ethnic origin between 18 and 75 years of age (limits included).
- Patient with painful diabetic symmetric polyneuropathy manifesting with distally distributed neuropathic pain.
- Stable glycaemic control with a value of HbA1c ≤ 10% at Screening Visit.
- Pain persisting for at least 3 months.
- Neuropathic pain confirmed by DN4 score ≥ 4 at Screening Visit.
Key exclusion criteria (24 listed)
- Known hypersensitivity to trazodone or gabapentin or their excipients.
- 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).
- Concomitant treatment with other medications for pain management.
- Concomitant treatment with potent CYP3A4 inhibitors (e.g. ketoconazole, ritonavir, indinavir) or drugs known to prolong QT interval.
- Use of trazodone or gabapentin in the previous 3 months.
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 |
|---|---|---|
| Trazodone 20 mgAlso: Trittico®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. | Drug | Group 1 |
| Trazodone 10 mgAlso: Trittico®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. | Drug | Group 2 |
| PlaceboOral 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. | Drug | Group 3 |
Primary outcome
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.
13 secondary outcomes
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 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 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 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 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 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 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 in Neuropathic Pain Symptom Inventory (NPSI) scale
Time frame: 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 in Hamilton Anxiety Rating Scale (HAM-A)
Time frame: 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.
Change in Leeds Sleep Evaluation Questionnaire (LSEQ)
Time frame: Baseline - Days 7, 14, 21, 28, 35, 42, 49, 56 and 63.
Frequency of treatment-related adverse events
Time frame: 9 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 28 Sep 2018.
- Derived from this study: PubMed 32936427Lipone P, Ehler E, Nastaj M, Palka-Kisielowska I, Cruccu G, Truini A, Di Loreto G, Del Vecchio A, Pochiero I, Comandini A, Calisti F, Cattaneo A. Efficacy and Safety of Low Doses of Trazodone in Patients Affected by Painful Diabetic Neuropathy and Treated with Gabapentin: A Randomized Controlled Pilot Study. CNS Drugs. 2020 Nov;34(11):1177-1189. doi: 10.1007/s40263-020-00760-2.
- Sponsor's websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trazodone 20 mg and Trazodone 10 mg in people with Painful Diabetic Neuropathy, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 20 sites in 3 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 9 inclusion and 24 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 28 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Czechia, Poland, Hungary. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change of item 5 score in Brief Pain Inventory Short Form (BPI-SF) scale (time frame: Baseline - Day 56). 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 NCT03202979, 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 28 Sep 2018.