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NCT05838755 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate Efficacy and Safety of GSK3858279 in Diabetic Peripheral Neuropathic Pain
A Phase 2 study, sponsored by GlaxoSmithKline.
- Terminated
- Registry status
- Phase 2
- Development phase
- 147
- Enrollment target
NCT05838755: Clinical Trial Phase 2 study, sponsored by GlaxoSmithKline.
NCT05838755 is a Phase 2 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 147 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05838755, a Phase 2 study, was terminated before completion, sponsored by GlaxoSmithKline.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 147 participants
- Enrollment target
Study Summary
This is a multicenter randomized, double-blind, placebo-controlled phase 2 study to evaluate efficacy, safety, tolerability, pharmacokinetics, and target engagement of GSK3858279 in adult participants with chronic Diabetic Peripheral Neuropathic Pain (DPNP). The primary objective of the study is to assess the efficacy of GSK3858279 in participants with DPNP who have been unable to sufficiently manage their pain.
Primary Outcome
The change from baseline (CFB) in the weekly average of the average daily pain score at Week 12 was assessed using Numeric Rating Scale (NRS). Participants recorded their average daily pain response daily using a Brief Pain Inventory Item 5. It is a single item designed for self-reporting average pain score for past 24 hours. Participants were asked to mark their average pain intensity daily, using the NRS, on an 11-point scale (0 = no pain, 10 = worst pain imaginable). The weekly average was co
Interventions
- DRUG Placebo
- DRUG GSK3858279
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 147 participants |
| Start Date | 2023-09-20 |
| Est. Completion | 2025-02-17 |
| Phase | Phase 2 |
Why NCT05838755 stopped before completion
NCT05838755 is an interventional study that assigns participants to a tested intervention. The registered 147 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05838755 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05838755 about?
NCT05838755 is a clinical study titled "A Study to Evaluate Efficacy and Safety of GSK3858279 in Diabetic Peripheral Neuropathic Pain". This is a multicenter randomized, double-blind, placebo-controlled phase 2 study to evaluate efficacy, safety, tolerability, pharmacokinetics, and target engagement of GSK3858279 in adult participants with chronic Diabetic Peripheral Neuropathic Pain (DPNP). The primary objective of the study is to ...
What is the current status of trial NCT05838755?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 147 participants. The study started on 2023-09-20. Estimated completion is 2025-02-17.
What interventions are being tested in trial NCT05838755?
The interventions under investigation include: Placebo (DRUG), GSK3858279 (DRUG).
Who is sponsoring clinical trial NCT05838755?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05838755's enrollment target sits among peer trials
147 495th of 2000 higher than 1,505 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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