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Diabetic NeuropathyPhase 2NCT00496457

Efficacy Study With 500 mg QD of TRO19622 vs Placebo in Patients With Painful Peripheral Diabetic Neuropathy

A Phase 2 study testing Experimental in people with Diabetic Neuropathy, run by Hoffmann-La Roche at 31 sites in 5 countries.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to assess the efficacy and safety of TRO19622 administered PO daily for 6 weeks compared to placebo administered PO daily in patients with painful peripheral diabetic neuropathy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Neuropathy
What is being tested?
Experimental
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
159 participants
Where
31 sitesin 5 countries
Study dates
May 2007to Dec 2008
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Be a male >18 years or a post-menopausal female (>60 years of age and at least 1 year of amenorrhea).
  • Have painful diabetic neuropathy of >6 months duration and are either pain treatment naive or have important side effects or inadequate relief from their current pain medication.
  • Be on current pain medication (prescribed analgesics), stable for at least 3 months before study entry (± 25% dosage of basic pain medication, top-up rescue medication allowed), or pain treatment naive.
  • Have stable diabetes, defined as HbA1c <10%, no changes in medication in the previous 3 months, and no new symptoms associated with diabetes in the previous 3 months.
  • Have scored >2 points on the Michigan Neuropathy Screening Instrument (MNSI), part B-physical assessment by health professional.
  • Have an ECG without any clinically significant abnormality.
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  • The following inclusion criteria should be ascertained at the baseline visit:
  • Have measurable pain perception (previous 24h) on the Likert numerical rating scale with a mean≥4.0 points calculated from at least 4 daily measurements over the 7 days immediately prior to the Baseline Visit.
  • Have stopped current pain medication at least 14 days prior to the Baseline Visit (except rescue medication).

Who cannot join

  • Be pregnant female, lactating female, or female of child bearing potential (≤60 years of age).
  • Have a documented neuropathy of any cause other than those mentioned in the inclusion criteria which might interfere with the assessment of the severity of pain (eg, including, but not limited to, alcoholic, uremic, B12, TSH, chemotherapy, HIV, post surgical, or post-traumatic neuropathy).
  • Have other neurological diseases that may produce weakness, sensory loss, or autonomic symptoms, or laboratory test abnormality.
  • Have been on pain treatment with strong opioids, more than 4 different drug regimens in the previous year, or a current combination of more than 2 drugs.
  • Have a current medication of lipid lowering agents other than statins.
  • Have a body mass index (BMI) >40 kg/m2 (obesity grade III).
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  • Had any surgery within the previous 2 months.
  • Have concurrent serious neurological disease (eg, dementia, multiple sclerosis, or any other disease that would impact the ability of the patient to provide consent for study participation).
  • Have a recent history (within the previous 6 months) or current evidence of alcohol or drug abuse.
  • Have concurrent unstable disease involving any system (eg, advanced carcinoma, myocardial infarction, clinical or ECG signs of myocardial ischemia, cardiac insufficiency i.e.≥ NYHA functional classification class 2, anginal symptoms, current symptoms of CAD, renal impairment, or any other condition that in the opinion of the Investigator would make the patient unsuitable for study participation).
  • Participated in any other investigational drug or therapy study within the previous 3 months.
  • Changed or interrupted current well-tolerated medication during the previous 3 months.
  • Lack of ability or willingness to give informed consent.
  • Be possibly dependent on the Investigator or the Sponsor (eg, including, but not limited to, affiliated employee).
  • Have hemostasis disorders or a current treatment of anticoagulants.
  • Have non-adequate renal and/or hepatic function as follows:
  • Renal - Blood creatinine >1.5X upper limit of normal (ULN)
  • Hepatic - Liver enzymes (ALT and AST) >2 X ULN
  • Have a known history of or current cardiac dysrhythmias and / or a known history of or current cardiovascular disease including myocardial infarction except patients with well controlled hypertension only.
  • Are not able to comply with regard to the known contraindications, warnings and precautions, drug-interactions and dosing recommendations of paracetamol.

Trial locations and contacts

31 sites in 5 countries.

31 sites in 5 countries

Germany10 sites

  • Diabetes Zentrum Mergentheim - Theodor-Klotzbücher-Straße 12

    Bad Mergentheim, 97980

  • Diabetologische Schwerpunktpraxis - Wilhelminenstr. 22

    Dinslaken-Bruch, 46537

  • Deutsches Diabetes Center, Institut für Klinische Diabetologie, Leibniz-Zentrum an der Heinrich-Heine Universität - Auf'm Hennekamp 65

    Düsseldorf, 40225

  • Klinikum Region Hannover GmbH - Klinikum Hannover Nordstadt - Diabetes Schwerpunktklinik -Medizinische Klinik - Haltenhoffstr. 41

    Hanover, 30167

  • Universitätsklinikum Heidelberg - Abteilung Innere Medizin I und klinische Chemie - Im Neuenheimer Feld 410

    Heidelberg, 69120

  • Pro scientia med - Osterweide 10

    Lübeck, 23562

  • IKFE GmbH - Institut für klinische Forschung und Entwicklung - Parcusstr. 8

    Mainz, 55116

  • Diabetes Schwerpunktpraxis - Gesundheitszentrum Potsdam GmbH - Hebbelstr. 1A

    Potsdam, 14467

  • Diabetes Schwerpunktpraxis - Gesundheitszentrum Potsdam GmbH, Hebbelstr. 1A

    Potsdam, 14467

  • Sophien- und Hufeland-Klinikum gGmbH - Klinik für Neurologie und Klinische Neurophysiologie - Henry-van-de-Velde-Str. 2

    Weimar, 99425

Other trials in Germany

Poland6 sites

  • NZOZ Specjalistyczny Ośrodek, Internistyczno-Diabetologiczny, ul Zamenhofa 10/20

    Bialystok, 15-435

  • Centrum Neurologii Klinicznej - Ul. Dwernickiego 8

    Krakow, 31-530

  • NZOZ Special-Med. Ul. Weteranów 46

    Lublin, 20-044

  • NZOZ MEDICA, ul. Jutrzenki 4

    Lublin, 20-538

  • NZOZ Beta-Med., Plac Wolności 17

    Rzeszów, 35-073

  • Adamiec Rajmund Gabinet Lekarski, ul. Żelazna 34

    Wroclaw, 53-428

Other trials in Poland

Serbia6 sites

  • Centre of Neurology, Clinical Hospital Centre "Dr Dragisa Misovic"

    Belgrade, 11000

  • Clinic for Neurology and Psychiatry, Clinical Hospital Centre "Zvezdara"

    Belgrade, 11000

  • Institute for Endocrinology, Clinical Centre Serbia

    Belgrade, 11000

  • Neurology Clinic, Military Medical Academy

    Belgrade, 11000

  • Neurology Department, Clinical Hospital Zemun

    Belgrade, 11000

  • Center for Neurology, Clinical Centre "Kragujevac"

    Kragujevac, 34000

Other trials in Serbia

Latvia5 sites

  • Daugavpils Regional Hospital - Vasarnicu street 20

    Daugavpils, LV-5420

  • Zemgale's Diabetes Centre SIA - Zemgales boulevard 15

    Jelgava, LV-3000

  • Doctor's Practice in Endocrinology - Meža prospekts 9, 2nd floor, 41.kabinets

    Ogre, LV-5001

  • Clinical Research Centre "Riga" - Katrinas dambis 16

    Riga, LV-1045

  • Talsu Hospital - Rugena street 7

    Talsi, LV-3201

Other trials in Latvia

Croatia4 sites

  • Univerity Hospital OSIJEK, Department for Diabetes and Endocrinology, J.Huttlera 4

    Osijek, 31 000

  • Genaral Hospital "Josip Bencevic", Internal Medicine Department-Unit for Diabetes, Andrije Stampara 42

    Slavonski Brod, 35 000

  • General Hospital Varazdin, Internal Medicine Department-Unit for Diabetes, Ivana Mestrovica bb

    Varaždin, 42 000

  • University Hospital "Dubrava", University Department for Internal Medicine, Institut for Diabetes, Endocrinology and Metabolic diseases, Avenija Gojka Suska 6

    Zagreb, 10 000

Other trials in Croatia

About this study

Official title: A Double-Blind, Randomized, Multicenter Study With 500 mg QD of TRO19622 Versus Placebo in Patients With Painful Peripheral Diabetic Neuropathy

The purpose of this study is to assess the efficacy and safety of TRO19622 administered PO daily for 6 weeks compared to placebo administered PO daily in patients with painful peripheral diabetic neuropathy.

Read the detailed description

Diabetic peripheral neuropathic pain (DPNP) affects approximately 11% of patients with diabetic peripheral neuropathy (DPN). Diabetic neuropathy as the underlying disease is the most common long-term complication of diabetes mellitus estimated to be experienced by a majority of patients at least in a mild manner.

Many patients with (DPNP) do not respond adequately to any individual treatment option. None of the various treatments used can be considered a cure. As a result, although a variety of drugs are available for the treatment of diabetic neuropathic pain, there is a strong need to develop new drugs with greater efficacy and/or fewer adverse effects.

The primary objective of the study is to compare the effect of TRO19622 versus placebo on the 24h neuropathic pain scores during the last 7 days of the 6-week treatment period.

Secondary objectives are to compare the efficacy on neuropathic pain, impact on emotional functioning, safety profile, pain time course, and response rate of TRO19622 versus placebo. Additionally, the pharmacokinetics of TRO19622 will be assessed.

Being tested
Experimental, Placebo comparator
Keywords
Diabetic Neuropathy, Painful Peripheral Diabetic Neuropathy, TRO19622, Trophos
Medical subject headings
Diabetic Neuropathies

What participants receive

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

  • ExperimentalDrug

    Capsules of TRO19622 (125 mg)- Once a day before noon meal during 6 weeks

  • Placebo comparatorDrug

    4 Capsules of PBO per day before noon meal

Study groups in NCT00496457
Study groupRoleWhat they receive
1ExperimentalTRO19622
Receives: Drug: Experimental
2Placebo comparatorNot described
Receives: Drug: Placebo comparator

What is being measured

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

  1. Effect of TRO19622 versus Placebo on the mean 24h neuropathic pain score on the Likert numerical rating scale.

    Measured: During the last 7 days of the 6-week treatment period

Secondary outcomes (3)

  1. 24h Pain time course

    Measured: Duration of study (within 11weeks after screening)

  2. Analysis for treatment effects: SF-MPQ, SF-BPI, SF36, POMS, Global Impression of Change (Patient / Investigator)

    Measured: Within 6 weeks of treatment

  3. Adverse events

    Measured: During the course of the study.

Timeline

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

  1. First posted4 Jul 2007 (estimated)
  2. Study startMay 2007
  3. Primary completionDec 2008
  4. Study completionDec 2008

Resources

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
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
159 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00496457
Sponsor's protocol ID
WN29860
Other IDs
EudraCT Number: 2006-004545-42, TRO19622 CLEQ 1104-1
Status last verified
Nov 2016
First submitted
22 Jun 2007
Last updated
22 Nov 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Experimental in people with Diabetic Neuropathy, run by Hoffmann-La Roche at 31 sites in 5 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 20 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 22 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in Germany, Poland, Serbia, Latvia, Croatia. 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?

Effect of TRO19622 versus Placebo on the mean 24h neuropathic pain score on the Likert numerical rating scale. (time frame: During the last 7 days of the 6-week treatment period). 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 NCT00496457.

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 22 Nov 2016.

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