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NCT02683785 · ClinicalTrials.gov registry record · Phase 2
A Study to Investigate the Efficacy and Safety of GSK3196165 in Inflammatory Hand Osteoarthritis
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 44
- Enrollment target
NCT02683785: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT02683785 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 44 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02683785, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 44 participants
- Enrollment target
Study Summary
This is a randomized, Phase IIa, multicentre, double-blind, placebo-controlled parallel group study with the primary objective to assess the efficacy potential of GSK3196165 on pain, in subjects with active inflammatory hand osteoarthritis (HOA). Approximately 40 subjects will be enrolled into the study, following a screening period of up to 4 weeks. The total treatment period will be 12 weeks, with the follow up period completing at Week 22. At least 40 subjects will be randomized across the two treatment arms, to either placebo or GSK3196165 in a 1:1 ratio.
Primary Outcome
Participants were required to complete a daily pain NRS based on their 24-hour average hand pain intensity with the anchors "0" (no pain) and "10" (worst imaginable pain), which was averaged over the 7 days prior to assessment visit. The 7 day average score was calculated as sum of daily 24 hours average hand pain NRS scores in the 7 days prior to assessment visit, divided by number of entries recorded in those 7 days. Baseline visit was at Day 1 and Baseline value was defined as the average of
Interventions
- DRUG Placebo
- DRUG GSK3196165
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2016-03-17 |
| Est. Completion | 2017-11-29 |
| Phase | Phase 2 |
What the finished NCT02683785 record still lists
NCT02683785 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02683785 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02683785 about?
NCT02683785 is a clinical study titled "A Study to Investigate the Efficacy and Safety of GSK3196165 in Inflammatory Hand Osteoarthritis". This is a randomized, Phase IIa, multicentre, double-blind, placebo-controlled parallel group study with the primary objective to assess the efficacy potential of GSK3196165 on pain, in subjects with active inflammatory hand osteoarthritis (HOA). Approximately 40 subjects will be enrolled into the ...
What is the current status of trial NCT02683785?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2016-03-17. Estimated completion is 2017-11-29.
What interventions are being tested in trial NCT02683785?
The interventions under investigation include: Placebo (DRUG), GSK3196165 (DRUG).
Who is sponsoring clinical trial NCT02683785?
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 NCT02683785's enrollment target sits among peer trials
44 1322nd of 2000 higher than 669 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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