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Small Molecule

GSK3858279 for Diabetic Neuropathy (NEPTUNE-17 Trial)

Phase 2
Recruiting
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant must be 18-75 years of age inclusive, at the time of signing the informed consent.
Type I or Type II diabetes with painful, distal, symmetrical, sensory motor neuropathy attributed to diabetes, of at least 6 months duration.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 27 weeks
Awards & highlights

NEPTUNE-17 Trial Summary

This trial studies an experimental drug to help manage chronic pain caused by diabetes in adults. The primary goal is to assess its effectiveness.

Who is the study for?
Adults aged 18-75 with Type I or II diabetes and chronic pain from Diabetic Peripheral Neuropathic Pain (DPNP) can join this study. They should have a BMI of 18-40 kg/m^2, experience consistent pain intensity, and be able to consent. Those with cardiovascular, renal, gastrointestinal issues or other causes of neuropathy are excluded.Check my eligibility
What is being tested?
The trial is testing GSK3858279's effectiveness in managing DPNP against a placebo. It's randomized and double-blind, meaning neither the participants nor the researchers know who gets the real drug versus the placebo until after results are collected.See study design
What are the potential side effects?
While specific side effects for GSK3858279 aren't listed here, common ones for new drugs may include allergic reactions, potential organ inflammation due to immune response changes, fatigue, digestive discomforts like nausea or diarrhea.

NEPTUNE-17 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 75 years old.
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I have diabetes with painful nerve damage in my hands and feet for at least 6 months.
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My average daily pain level is between 4 and 9 out of 10.

NEPTUNE-17 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 27 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 27 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in the weekly average of average daily pain intensity at Week 12, assessed on the Numeric Rating Scale (NRS)
Secondary outcome measures
Area under the time-concentration curve (AUC) over the dosing interval (0-tau) (AUC[0-tau]) of GSK3858279
Average concentration over a dosing interval (Cavg) of GSK3858279
Change from Baseline in Haematology Parameters: Red blood cell (RBC) count, (Trillion cells per liter)
+14 more

NEPTUNE-17 Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: GSK3858279 Dose 2Experimental Treatment1 Intervention
Participants will receive GSK3858279 dose 2.
Group II: GSK3858279 Dose 1Experimental Treatment1 Intervention
Participants will receive GSK3858279 dose 1.
Group III: PlaceboPlacebo Group1 Intervention
Participants will receive placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GSK3858279
2022
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,755 Previous Clinical Trials
8,070,595 Total Patients Enrolled
23 Trials studying Pain
3,247 Patients Enrolled for Pain
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,700 Total Patients Enrolled
20 Trials studying Pain
3,034 Patients Enrolled for Pain

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experimental treatment open to subjects aged 70 or below?

"This trial has a limited age range of 18 to 75. There are 67 trials available for minors while 420 clinical trials focus on patients aged 65 and above."

Answered by AI

What safety precautions have been implemented for GSK3858279 Dose 2?

"According to our team at Power, GSK3858279 Dose 2 is moderately safe with a rating of 2; this follows from the fact that Phase 2 trials have yet to demonstrate any efficacy and only provide limited safety data."

Answered by AI

Are there multiple sites actively participating in the clinical trial within this municipality?

"The current research is being conducted at 72 centres across the country. Of these, Surprise, Lomita and Tustin are particularly close to interested participants. Selecting an evaluation site near you can reduce travel time if you join this study."

Answered by AI

Does this scientific experiment accept new participants?

"Affirmative. According to the data available on clinicaltrials.gov, this trial is still recruiting participants since it was first posted on September 8th 2023 and last updated on October 11th 2023. 240 subjects need to be enrolled into this research effort from 72 different locations."

Answered by AI

What is the enrollment capacity of this research endeavor?

"That is correct. Clinicaltrials.gov confirms that this research endeavour, which was first posted on September 8th 2023, is still actively seeking candidates to participate. In total, 240 participants must be recruited from 72 different sites nationwide."

Answered by AI

What specific qualifications do individuals need to meet in order to be considered for participation in this trial?

"Seeking out an aggregate of 240 adults aged 18 to 75 who are struggling with pain, this clinical trial also requires the following criteria be met: a BMI within 18-40 kg/m^2 (inclusive), Type I or II diabetes present for at least 6 months prior, and average daily pain intensity over 24 hours scored ≥4 on the 11-point NRS. All participants must consent in writing before being admitted into the study."

Answered by AI

Who else is applying?

What site did they apply to?
GSK Investigational Site
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate Efficacy and Safety of GSK3858279 in Diabetic Peripheral Neuropathic Pain
2023. "A Study to Evaluate Efficacy and Safety of GSK3858279 in Diabetic Peripheral Neuropathic Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05838755.
All > Nerve Pain > Diabetic Neuropathy
~141 spots leftby Mar 2025
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