Study on the Effectiveness of ODM-111 and Paracetamol for Chronic Pain in Patients with Diabetic Peripheral Neuropathy

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What is this study about?

This clinical trial is focused on studying the effectiveness and safety of a new medication called ODM-111 for treating chronic pain due to diabetic peripheral neuropathy. Diabetic peripheral neuropathy is a condition that affects the nerves, often causing pain in the legs and feet, and is a common complication of diabetes. The study will compare the effects of ODM-111 with a placebo to understand how well the medication works in reducing pain.

The purpose of the study is to evaluate how effective ODM-111 is in managing pain associated with diabetic peripheral neuropathy. Participants in the study will receive either ODM-111 or a placebo, and their pain levels will be monitored over a period of six weeks. The medication is taken orally in the form of tablets. Throughout the study, participants will be asked to record their daily pain levels using a simple numerical scale to help researchers assess any changes in pain intensity.

In addition to ODM-111, the study will also involve the use of Para-Tabs, which contain paracetamol, a common pain reliever. The study aims to provide valuable information on the potential benefits of ODM-111 for individuals suffering from chronic pain due to diabetic peripheral neuropathy, with the hope of improving treatment options for this condition.

1 initial visit

Upon joining the study, participants will attend an initial visit. During this visit, participants will receive detailed information about the study and will be asked to provide signed informed consent to confirm their willingness to participate.

Participants will undergo a screening process to ensure they meet the study’s eligibility criteria, which includes age, body mass index, and a diagnosis of diabetic peripheral neuropathy with chronic pain.

2 baseline assessment

Participants will complete a baseline assessment, which involves recording their average pain intensity using an 11-point numeric rating scale. This assessment will be based on daily pain evaluations over at least five of the seven days preceding the baseline visit.

3 treatment phase

Participants will begin the treatment phase, which involves taking the study medication, ODM-111, in tablet form. The medication is administered orally.

The dosage and frequency of ODM-111 will be determined by the study protocol, and participants will be required to take the medication as instructed for the duration of the study.

4 ongoing assessments

Throughout the study, participants will be asked to maintain a daily electronic diary (eDiary) to record their pain intensity over the previous 24 hours. This information will be used to evaluate the effectiveness of the treatment.

Participants will attend regular follow-up visits to monitor their progress and any potential side effects of the medication.

5 end of study

At the end of the study, participants will undergo a final assessment to evaluate changes in their pain levels and overall health.

Participants will be provided with information on how to safely discontinue the study medication and any necessary follow-up care.

Who Can Join the Study?

Signed informed consent to participate in the trial.
Men and women aged between 18 and 80 years at the time of the screening visit.
Body Mass Index (BMI) between 18 and 45 kg/m² at the screening visit. BMI is a measure of body fat based on height and weight.
Have Type 1 or Type 2 diabetes for at least 6 months with well-controlled blood sugar levels for the 3 months before the screening.
Diagnosed with painful diabetic peripheral neuropathy (DPN) for at least 6 months before the screening visit, with pain mainly in the legs.
An average pain intensity of a certain level on a scale from 0 to 10 in the legs during the past 24 hours at screening and at the start of the study.
A weekly average of daily pain intensity on a scale from 0 to 10 at the start of the study, based on daily assessments over at least 5 of the 7 days before the start of the study.
A Douleur Neuropathique 4 (DN4) score of a certain level at the screening visit. The DN4 is a questionnaire used to assess nerve pain.
Female participants with male partners who can have children and male participants with female partners who can have children must use a highly effective form of birth control if sexually active and not permanently sterilized. This applies to females from 4 weeks before the first study treatment and to males from the first day of treatment until 3 months after the end of the study. Women who have not had a menstrual cycle for 1 year are considered not able to have children and can be included. Male participants cannot donate sperm until 3 months after the end of the study.

Who Cannot Join the Study?

Patients who do not have chronic pain due to diabetic peripheral neuropathy cannot participate. This means the study is only for those who have nerve pain caused by diabetes.
Patients who are not within the specified age range cannot participate. The study is for adults only.
Patients who are not willing to follow the study procedures cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients with other serious health conditions that might interfere with the study cannot participate.
Patients who are currently participating in another clinical trial cannot participate.
Patients who have had a recent surgery or are planning to have surgery during the study period cannot participate.
Patients with a history of substance abuse cannot participate.
Patients who have allergies to the study medication or its ingredients cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
NBR Polska Tomasz Klodawski	Warsaw	Poland
Diahaza s.r.o.	Zlin	Czechia
Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p.	Lublin	Poland
Osteo-Medic s.c. Artur Racewicz, Jerzy Supronik	Bialystok	Poland
Praxis Reinfeld Mitte	Reinfeld	Germany
Klinische Forschung Karlsruhe GmbH	Karlsruhe	Germany
PRAKTYKA LEKARSKA EWA KRZYŻAGÓRSKA	Poznan	Poland
NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska Lekarzy	Poznan	Poland

Other Sites

Site Name	City	Country
SYNEXUS Magyarorszag Kft.	Budapest	Hungary
Rcmed Oddzial Sochaczew	Sochaczew	Poland
Silmedic Sp. z o.o.	Katowice	Poland
OHA-Med Sp. z o.o.	Warsaw	Poland
Somni bene Institut fuer medizinische Forschung und Schlafmedizin Schwerin GmbH	Schwerin	Germany
Pro Familia Altera Sp. z o.o.	Katowice	Poland
Siteworks GmbH	Hanover	Germany
Neurohk s.r.o.	Chocen	Czechia
University Multiprofile Hospital For Active Treatment Saint Georgi EAD	Plovdiv	Bulgaria
Diagnostic Consultative Center 14 Sofia EOOD	Sofia	Bulgaria
Medical Center Smolyan Clinical Research OOD	Smolyan	Bulgaria
Diagnostic-consultative center “Aleksandrovska” EOOD	Sofia	Bulgaria
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD	Sofia	Bulgaria
Vestra Clinics s.r.o.	Rychnov Nad Kneznou	Czechia
Klinische Forschung Berlin GbR	Berlin	Germany
University Of Szeged	Szeged	Hungary
Mcznzuv Cstufp Amneyidro 2kxy Esrj	Pleven	Bulgaria
Kgrmrshvj Ftihvkhbs Dcxvmnj Gtki	Dresden	Germany
Dwek Mkviipl sszcsm	Prague	Czechia
Nlvt Smymv Svd z orjg	Warsaw	Poland
Mddvddgzu Iuexomdvfx Cljzexmq Sqdajdaj Sux z oubc	Warsaw	Poland
djla Mhxxq Rcnexdq Tszxhx Cdzf	Hradec Kralove	Czechia
Cjgmhfa Mvyowzei Hbmt Cqsgsa	Lublin	Poland
Cwd Cllmsdgf Rgqsxjak Sfrsydwb Mytsdixk Gjsk	Mannheim	Germany
Mvbuqcx Cgjcxp Mkbejmyiln Pnoeit Ozf	Pleven	Bulgaria
Uxp Mrnufus Tcntgb Ksnz	Budapest	Hungary

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	01.11.2024
Czechia	Not recruiting	01.11.2024
Germany	Not recruiting	01.11.2024
Hungary	Not recruiting	01.11.2024
Poland	Not recruiting	01.11.2024

Trial locations

Investigated drugs:

Paracetamol

ODM-111 is a medication being studied for its ability to help manage chronic pain caused by diabetic peripheral neuropathy. This condition is a type of nerve damage that can occur in people with diabetes, leading to pain, tingling, or numbness, usually in the feet and hands. The goal of using ODM-111 in this trial is to see if it can effectively reduce the pain associated with this nerve damage and improve the quality of life for those affected. The study also aims to assess how well patients tolerate the medication, meaning how it affects them and whether it causes any side effects. By participating in this trial, patients help researchers understand if ODM-111 could be a useful treatment option for managing chronic pain due to diabetic peripheral neuropathy.

Chronic Pain Due to Diabetic Peripheral Neuropathy – Diabetic Peripheral Neuropathy is a condition that affects the nerves in the extremities, primarily the feet and legs, due to prolonged high blood sugar levels. This nerve damage can lead to chronic pain, which is persistent and can vary in intensity. The pain is often described as burning, tingling, or sharp, and it can significantly impact daily activities and quality of life. Over time, the condition may lead to increased sensitivity to touch or even numbness in the affected areas. The progression of nerve damage can be gradual, and symptoms may worsen if blood sugar levels are not well controlled.

Trial ID:

2024-513595-17-00

Protocol code:

3133004

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effectiveness of ODM-111 and Paracetamol for Chronic Pain in Patients with Diabetic Peripheral Neuropathy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?