Study on GSK3858279 for Adults with Chronic Diabetic Nerve Pain

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What is this study about?

This clinical trial is focused on studying a condition known as Diabetic Peripheral Neuropathic Pain (DPNP), which is a type of nerve pain that affects people with diabetes. The study will evaluate a new treatment called GSK3858279, which is administered as an injection. This treatment is being compared to a placebo to understand its effectiveness in reducing pain for individuals with DPNP.

The purpose of the study is to assess how well GSK3858279 works in managing pain associated with DPNP. Participants in the study will receive either the new treatment or a placebo. The study will last for a period of 12 weeks, during which participants will be monitored to see how their pain levels change over time. The study aims to provide valuable information on the safety and potential benefits of this new treatment for people suffering from DPNP.

Throughout the study, participants will receive regular check-ups and assessments to ensure their well-being and to gather data on the treatment’s effects. This trial is an important step in exploring new options for managing pain in individuals with diabetic nerve pain, potentially leading to improved quality of life for those affected by this condition.

1 initial visit

Upon joining the study, an initial visit is scheduled. During this visit, eligibility is confirmed based on specific criteria, including age, diabetes type, and pain characteristics.

A detailed medical history is reviewed, and a physical examination is conducted. A pain questionnaire is completed to assess the level of pain experienced.

2 baseline assessment

A baseline assessment is conducted to record the initial pain levels using a Numeric Rating Scale (NRS). This scale ranges from 0 to 10, where 0 means no pain and 10 means the worst possible pain.

Additional tests may be performed to ensure all health parameters are within the required range for participation.

3 randomization and treatment

Participants are randomly assigned to receive either the study medication, GSK3858279, or a placebo. This is done in a double-blind manner, meaning neither the participant nor the study team knows which treatment is being administered.

The medication is administered as a subcutaneous injection. The dosage and frequency are determined by the study protocol and are explained during this phase.

4 treatment period

The treatment period lasts for a specified duration, during which the medication is administered regularly as per the study schedule.

Participants are required to maintain a stable anti-diabetic medication regimen and report any changes in their condition or medication use.

5 regular assessments

Regular assessments are conducted to monitor pain levels and any side effects. These assessments include completing the pain questionnaire and other evaluations as required.

Participants are asked to use a patient eDiary to record daily pain levels and any use of rescue medication.

6 final assessment

At the end of the treatment period, a final assessment is conducted to evaluate changes in pain levels compared to the baseline.

The results are used to determine the efficacy of the study medication in managing diabetic peripheral neuropathic pain.

7 follow-up

A follow-up period is included to monitor any long-term effects of the treatment. Participants may be required to attend additional visits or complete further assessments.

The study team provides guidance on any necessary actions or precautions to be taken after the study concludes.

Who Can Join the Study?

Age between 18 and 75 years old at the time of signing the consent form.
Have Type I or Type II diabetes with painful nerve damage in the feet or legs due to diabetes for at least 6 months.
Pain must have started in both lower legs and is not due to infection or injury.
Diagnosis confirmed by a positive result on a specific questionnaire for nerve pain.
Blood sugar levels, measured by HbA1c, must be less than 97 mmol/mol (less than 11%).
On a stable diabetes medication plan for at least 30 days before the study starts. Adjusting insulin dose is okay, but starting insulin treatment is not allowed within 30 days before the study.
No recent unplanned hospital visits due to not following diabetes treatment or uncontrolled diabetes.
Pain score between 4 and 9 on a scale from 0 to 10 for average daily pain over the past 24 hours at screening.
During the initial study period, average daily pain score must also be between 4 and 9 on the same scale. Use of additional pain medication must be within allowed limits.
History of not getting enough pain relief from, or not being able to tolerate, or having a reason not to use current standard pain treatments like certain antidepressants or anticonvulsant drugs.
Willing and able to understand and participate in all study evaluations and complete all required tests and procedures, including using a patient diary.
BMI (Body Mass Index) must be between 18 and 40 kg/m².
Male or female participants. Female participants must not be pregnant or breastfeeding and must meet specific conditions regarding pregnancy prevention and testing.
Capable of giving signed informed consent and willing to follow the study requirements and restrictions.

Who Cannot Join the Study?

Patients who do not have Diabetic Peripheral Neuropathic Pain cannot participate. This is a type of pain caused by nerve damage due to diabetes.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Patients who are part of a vulnerable population may not be eligible. This includes groups that might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Gemeinschaftspraxis Drs. Josef und Wilma Großkopf	Wallerfing	Germany

Other Sites

Site Name	City	Country
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Hospital Hm Nou Delfos	Barcelona	Spain
Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace	Mulhouse	France
Centre Hospitalier Sud Francilien	Corbeil Essonnes	France
Siteworks GmbH	Hanover	Germany
Pratia S.A.	Skorzewo	Poland
Servei De Salut De Les Illes Balears	Palma	Spain
Rcmed Oddzial Sochaczew	Sochaczew	Poland
Hospital Universitario De La Ribera	Alzira	Spain
Pro Familia Altera Sp. z o.o.	Katowice	Poland
Silmedic Sp. z o.o.	Katowice	Poland
Instytut Diabetologii Sp. z o.o.	Warsaw	Poland
Hospital Universitario Infanta Sofía	San Sebastian De Los Reyes	Spain
Centre Hospitalier De Maubeuge	Maubeuge	France
PSHI Praxis GmbH	Mainz	Germany
Institut fuer Diabetesforschung Muenster GmbH	Munster	Germany
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Zengyse fffb kruoxqzff Fsqnnpfsh Dui Is Saefjcf Gytm	Bad Homburg	Germany
Nyqjgndbvj Saz z otbg sfvcn	Katowice	Poland
Czwlja Hncxmwetsrc Rtkgvktz Daqooawdilulwu	Angers	France
Cnequir Bulzl Kgtzqvahsgj Ppgtoekg Sjz z okwf	Gdansk	Poland
Hbpuoqfo Uplsngyvzrvbm da A Cdkncm	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
France	Not recruiting	18.05.2024
Germany	Not recruiting	18.05.2024
Poland	Not recruiting	18.05.2024
Spain	Not recruiting	18.05.2024

Trial locations

Investigated drugs:

Gsk3858279

GSK3858279 is a medication being studied for its potential to help people with chronic Diabetic Peripheral Neuropathic Pain, which is a type of nerve pain that can occur in people with diabetes. This medication is being tested to see if it can reduce pain levels in patients who suffer from this condition. The study aims to understand how well the medication works, how safe it is, and how the body processes it. Participants in the trial receive this medication to see if it can effectively manage their pain compared to those who do not receive it.

Diabetic Peripheral Neuropathic Pain – Diabetic Peripheral Neuropathic Pain is a condition that occurs as a complication of diabetes, affecting the nerves outside the brain and spinal cord. It primarily involves damage to the peripheral nerves, leading to symptoms such as pain, tingling, and numbness, usually in the feet and hands. The progression of this condition is often gradual, with symptoms worsening over time if blood sugar levels are not well controlled. The pain associated with this condition can vary in intensity and may be described as burning, stabbing, or shooting. As the condition progresses, it can lead to a loss of sensation in the affected areas, increasing the risk of injury. Managing blood sugar levels is crucial in slowing the progression of nerve damage.

Trial ID:

2022-502313-28-00

Protocol code:

214221

NCT ID:

NCT05838755

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on GSK3858279 for Adults with Chronic Diabetic Nerve Pain

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