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NCT02311881 · ClinicalTrials.gov registry record · Phase 3
A 12-Week Efficacy Study of Paracetamol 1000mg Sustained-release Tablets in Patients With Osteoarthritis
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 960
- Enrollment target
NCT02311881: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT02311881 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 960 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (24% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02311881, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 960 participants
- Enrollment target
Study Summary
The purpose of the study is to determine whether paracetamol 1000 mg sustained-release (SR) tablets administered orally, twice daily are effective and safe in the treatment of patients with osteoarthritis of the knee or hip.
Primary Outcome
The WOMAC Osteoarthritis Index is a 24-item questionnaire that assesses pain, physical function, and stiffness in the target joint. WOMAC Pain was measured using visual analogue scale (VAS) ranging from 0mm (no pain) to 100mm (extreme pain) at baseline and at week 1, 2, 4, 8, and 12. Lower values represent a better outcome. At each time point the assessment included 5 WOMAC Pain items: 1-walking on flat, 2-going up down stairs, 3-at night while in bed, 4-sitting or lying; 5-standing upright. Mea
Interventions
- DRUG Placebo
- DRUG Paracetamol 1000 mg SR tablets
- DRUG Paracetamol 665 mg SR tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 960 participants |
| Start Date | 2015-01 |
| Est. Completion | 2016-02 |
| Phase | Phase 3 |
What the finished NCT02311881 record still lists
NCT02311881 is an interventional study that assigns participants to a tested intervention. The registered 960 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (24% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02311881 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02311881 about?
NCT02311881 is a clinical study titled "A 12-Week Efficacy Study of Paracetamol 1000mg Sustained-release Tablets in Patients With Osteoarthritis". The purpose of the study is to determine whether paracetamol 1000 mg sustained-release (SR) tablets administered orally, twice daily are effective and safe in the treatment of patients with osteoarthritis of the knee or hip.
What is the current status of trial NCT02311881?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 960 participants. The study started on 2015-01. Estimated completion is 2016-02.
What interventions are being tested in trial NCT02311881?
The interventions under investigation include: Placebo (DRUG), Paracetamol 1000 mg SR tablets (DRUG), Paracetamol 665 mg SR tablets (DRUG).
Who is sponsoring clinical trial NCT02311881?
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 NCT02311881's enrollment target sits among peer trials
960 330th of 2000 higher than 1,669 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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