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Gsk3858279

Clinical trials are studying Gsk3858279 in people with pain from diabetic peripheral neuropathic pain and knee osteoarthritis. These studies are looking at whether it can reduce pain and how safe it is in adults. Both trials are phase 2 studies and have already been completed.

Table of Contents

Clinical trials overview

Two Phase 2 clinical trials studied Gsk3858279 in adults with pain conditions.[1][2] Both studies were interventional, which means the researchers gave a study treatment and compared it with placebo, a treatment with no active drug.[1][2]

One trial was NEPTUNE-17, and the other was MARS-17.[1][2] Both trials are listed as completed.[1][2]

Diabetic peripheral neuropathic pain study

The NEPTUNE-17 study, NCT05838755, tested Gsk3858279 in people with diabetic peripheral neuropathic pain (DPNP), which is nerve pain linked to diabetes.[1] The study aimed to see whether Gsk3858279 could improve pain compared with placebo.[1]

This study enrolled 240 participants and used a 400 mg subcutaneous injection of Gsk3858279, compared with sterile 0.9% sodium chloride as placebo.[1] The source data does not give more details about the participant rules beyond the condition studied and adult population.[1]

Knee osteoarthritis pain study

The MARS-17 study, NCT05838742, tested Gsk3858279 in adults with knee osteoarthritis pain.[2] Osteoarthritis is a joint disease where the cushioning in the joint wears down, which can cause pain and stiffness.[2]

This dose-finding study enrolled 420 participants and also used a 400 mg subcutaneous injection of Gsk3858279, with sterile 0.9% sodium chloride as placebo.[2] The goal was to see whether Gsk3858279 could reduce knee pain better than placebo.[2]

Study design and main outcomes

Both trials looked at efficacy, which means how well the treatment works, and safety, which means how well it is tolerated in the study setting.[1][2] The main outcome in each study was the change from baseline in weekly average daily pain intensity at Week 12.[1][2]

Pain was measured with the Numeric Rating Scale (NRS), a number-based pain score used in clinical research.[1][2] “Baseline” means the starting pain level before treatment, so the studies compared pain after treatment with the starting point.[1][2]

Who participated

The trials focused on adults with either diabetic peripheral neuropathic pain or knee osteoarthritis pain.[1][2] The source data does not list extra details such as age limits, previous treatments, or other entry rules.[1][2]

  • DPNP trial: adults with diabetic nerve pain in the NEPTUNE-17 study.[1]
  • Knee osteoarthritis trial: adults with knee pain from osteoarthritis in the MARS-17 study.[2]
  • Shared design: both studies compared Gsk3858279 with placebo and measured pain at Week 12.[1][2]
Trial ID Phase Condition studied Status Enrollment
NCT05838755 Phase 2 Diabetic peripheral neuropathic pain Completed 240
NCT05838742 Phase 2 Knee osteoarthritis pain Completed 420

FAQ

  • What is Gsk3858279 being studied for? The trials are studying Gsk3858279 for pain caused by diabetic peripheral neuropathic pain and knee osteoarthritis. The main goal is to see if it can lower pain scores compared with placebo.
  • Who took part in these trials? Adults with diabetic peripheral neuropathic pain took part in one trial, and adults with knee osteoarthritis pain took part in the other. The source data does not give more detailed entry rules.
  • What phase are the Gsk3858279 trials? Both studies were Phase 2 trials. Phase 2 means the treatment is being tested in patients to learn more about its effect and safety.
  • What did the trials measure? The main outcome in both trials was change in average daily pain intensity at Week 12. Pain was measured with the Numeric Rating Scale, which is a simple pain score scale.
  • Were these trials completed? Yes. Both Gsk3858279 trials in the source data are listed as completed. One study focused on diabetic peripheral neuropathic pain and the other on knee osteoarthritis pain.

Ongoing Clinical Trials on Gsk3858279

  • Study on GSK3858279 for Adults with Moderate to Severe Knee Osteoarthritis Pain

    Not recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    France Germany Spain

  • Study on GSK3858279 for Adults with Chronic Diabetic Nerve Pain

    Not recruiting

    2 1
    Investigated drugs:
    France Germany Poland Spain

Glossary

  • Phase 2: A stage of clinical research that studies how well a treatment works and continues to check safety in people with the condition being treated.
  • Interventional study: A study where researchers give a treatment or placebo and then compare results.
  • Placebo: An inactive treatment used for comparison. It looks like the study treatment but does not contain the active drug.
  • Diabetic peripheral neuropathic pain: Pain caused by nerve damage related to diabetes, often in the feet or legs.
  • Knee osteoarthritis pain: Pain in the knee caused by osteoarthritis, a condition where joint cartilage wears down over time.
  • Numeric Rating Scale (NRS): A pain scale where people rate their pain with a number, often from 0 to 10.
  • Baseline: The starting point before treatment begins. Results are often compared with this starting value.
  • Week 12: The time point 12 weeks after the study starts or after treatment begins, depending on the study plan.
  • Efficacy: How well a treatment works.
  • Safety: How well a treatment is tolerated and whether it causes unwanted problems.

References