Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03785756 · ClinicalTrials.gov registry record · Phase 3
Efficacy of 300 mg Ibuprofen Prolonged-Release Tablets for the Treatment of Pain After Surgical Removal of Impacted Third Molars
A Phase 3 study, sponsored by Reckitt Benckiser Healthcare (UK) Limited.
- Completed
- Registry status
- Phase 3
- Development phase
- 280
- Enrollment target
NCT03785756: Completed Phase 3 study, sponsored by Reckitt Benckiser Healthcare (UK) Limited.
NCT03785756 is a Phase 3 study that has completed, run by Reckitt Benckiser Healthcare (UK) Limited. The registered enrollment target is 280 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03785756, a Phase 3 study, has completed, sponsored by Reckitt Benckiser Healthcare (UK) Limited.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 280 participants
- Enrollment target
Study Summary
This is a single centre, randomised, double-blind, double-dummy, parallel group, multiple-dose, active and placebo-controlled efficacy study to evaluate the efficacy and safety of 2×300mg ibuprofen Prolonged Release (PR) tablets in subjects with postoperative dental pain.
Primary Outcome
SPID12 was used to compare the test product (2 × 300 mg ibuprofen PR tablets) and comparator product (2 × 200 mg ibuprofen IR tablets three times a day \[TID\]) against the placebo product. An 11-point (0-10) numeric rating scale (NRS) for pain was used to assess pain intensity, where a higher score indicates a greater amount of pain. SPID12 was calculated using the summed pain intensity difference (change from Time 0) under the NRS-time curve from 15 minutes through 12 hours calculated using th
Interventions
- DRUG Ibuprofen 300 mg Oral Tablet
- DRUG Ibuprofen 200 mg Oral Tablet
- DRUG Placebo of PR tablet
- DRUG Placebo of IR tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 280 participants |
| Start Date | 2019-04-29 |
| Est. Completion | 2020-02-28 |
| Phase | Phase 3 |
What the finished NCT03785756 record still lists
NCT03785756 is an interventional study that assigns participants to a tested intervention. The registered 280 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 4 interventions - of which Ibuprofen 300 mg Oral Tablet is the first listed.
NCT03785756 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03785756 about?
NCT03785756 is a clinical study titled "Efficacy of 300 mg Ibuprofen Prolonged-Release Tablets for the Treatment of Pain After Surgical Removal of Impacted Third Molars". This is a single centre, randomised, double-blind, double-dummy, parallel group, multiple-dose, active and placebo-controlled efficacy study to evaluate the efficacy and safety of 2×300mg ibuprofen Prolonged Release (PR) tablets in subjects with postoperative dental pain.
What is the current status of trial NCT03785756?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 280 participants. The study started on 2019-04-29. Estimated completion is 2020-02-28.
What interventions are being tested in trial NCT03785756?
The interventions under investigation include: Ibuprofen 300 mg Oral Tablet (DRUG), Ibuprofen 200 mg Oral Tablet (DRUG), Placebo of PR tablet (DRUG), Placebo of IR tablet (DRUG).
Who is sponsoring clinical trial NCT03785756?
This trial is sponsored by Reckitt Benckiser Healthcare (UK) Limited, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03785756's enrollment target sits among peer trials
280 1195th of 2000 higher than 802 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04084730 · 280 participants · Phase 2
Study of 3-Day Partial Breast Radiation Therapy in Women With Breast Cancer
- NCT04518657 · 280 participants · NA
Internet-Delivered Lifestyle Physical Activity Intervention for Cognitive Processing Speed in Multiple Sclerosis
- NCT04634916 · 280 participants · NA
Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System
- NCT04829617 · 280 participants · NA
Promoting Well-being and Health in Heart Failure
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI