Trial · NCT01389284
Evaluate Efficacy and Safety of Extended Release (ER) Naproxen Sodium
NCT01389284, Phase 3, Completed, Bayer; results first posted 2013-05-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluate Efficacy and Safety of Extended Release (ER) Naproxen Sodium. Trials, record NCT01389284. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01389284
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluate Efficacy and Safety of Extended Release (ER) Naproxen Sodium
- NCT number
- NCT01389284
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 300 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Pain, Postoperative
- Interventions
- Naproxen Sodium ER (BAYH6689), Naproxen Sodium IR (Aleve, BAYH6689), Naproxen Sodium ER Placebo, Naproxen Sodium IR Placebo
- First posted
- 2011-07-08
- Last updated
- 2015-08-25
- Other registries' IDs
- eudract:2014-005272-28
- Results first posted
- 2013-05-07
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Summed, Time-weighted Pain Intensity Difference From 0 to 24 Hours Postdose (SPID0-24) | From 0 to 24 hours post-dose | SPID0-24 was calculated by multiplying the pain intensity difference score at each post-dose timepoint by the duration (in hours) since the preceding timepoint and then summing these values over 0 to 24 hours. Pain intensity was measured at baseline, 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 24 hours using the 4-point categorical pain intensity scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe. SPID0-24 can vary from -24 to 72. The positive SPID value indicates improvement of pain relief. The higher the SPID value, the more improvement of pain relief. |
| Secondary | Summed, Time-weighted Pain Intensity Differences (SPID) | 0-6, 0-8, 0-12, 0-16 and 16-24 hours postdose | Pain intensity was measured at baseline, 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 24 hours using the 4-point categorical pain intensity scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total possible score ranges of SPIDs are SPID0-6: -6 to 18, SPID0-8: -8 to 24, SPID0-12: -12 to 36, SPID0-16: -16 to 48, SPID16-24: -8 to 24. The positive SPID value indicates improvement of pain relief. The higher the SPID value, the more improvement of pain relief. |
| Secondary | Summed, Time-weighted Total Pain Relief Scores (TOTPARs) | 0-6, 0-8, 0-12, 0-16, 0-24, and 16-24 hours postdose | TOTPARs were derived by multiplying the pain relief score at each post-dose timepoint by the duration (in hours) since the preceding timepoint and then summing these values over the specified interval. Pain Relief was evaluated at 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 24 hours postdose, using the 5-point overall pain relief scale: 0 = No relief, 1 = A little relief, 2 = Some relief, 3 = A lot of relief, 4 = Complete relief. The possible total score ranges of TOTPARs are: TOTPAR0-6: 0 to 18, TOTPAR0-8: 0 to 24, TOTPAR0-12: 0 to 36, TOTPAR0-16: 0 to 48, TOTPAR0-24: 0 to 72, TOTPAR16-24: 0 to 24. |
| Secondary | Pain Intensity Differences (PIDs) by Time From Initial Dose | At 0, 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdose | Pain intensity was evaluated using a 4-point Categorical Pain Intensity Rating Scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe |
| Secondary | Pain Relief From Initial Dose | At 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdose | Pain Relief was evaluated using the 5-point overall pain relief scale: 0 = No relief, 1 = A little relief, 2 = Some relief, 3 = A lot of relief, 4 = Complete relief |
| Secondary | Median Time to First Intake of Rescue Medication | Up to 24 hours postdose | Time to first use of rescue medication was estimated using Kaplan-Meier method and analyzed by a logrank test stratified by baseline pain intensity. If at least 50% of subjects in a treatment group took rescue medication, the median time to first rescue was determined for that treatment group. |
| Secondary | Cumulative Percentage of Participants Who Took Rescue Medication | At 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdose | |
| Secondary | Number of Times the Participants Took Rescue Medication Over the 24-hour Period | 24 hours postdose | |
| Secondary | Global Assessment of the Investigational Product as a Pain Reliever | 24 hours postdose or immediately before the first intake of rescue medication | Global assessment of investigational product as a pain reliever was rated on a 5-point categorical scale: 0 = poor, 1 = fair, 2 = good, 3 = very good, 4 = excellent |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Summed, Time-weighted Pain Intensity Difference From 0 to 24 Hours Postdose (SPID0-24) | From 0 to 24 hours post-dose | Intent-to-treat (ITT) | Score on the scale | MEAN |
| SECONDARY | Summed, Time-weighted Pain Intensity Differences (SPID) | 0-6, 0-8, 0-12, 0-16 and 16-24 hours postdose | Intent-to-treat (ITT) | Score on the scale | MEAN |
| SECONDARY | Summed, Time-weighted Total Pain Relief Scores (TOTPARs) | 0-6, 0-8, 0-12, 0-16, 0-24, and 16-24 hours postdose | Intent-to-treat (ITT) | Score on the scale | MEAN |
| SECONDARY | Pain Intensity Differences (PIDs) by Time From Initial Dose | At 0, 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdose | Intent-to-treat (ITT) | Score on the scale | MEAN |
| SECONDARY | Pain Relief From Initial Dose | At 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdose | Intent-to-treat (ITT) | Score on the scale | MEAN |
| SECONDARY | Median Time to First Intake of Rescue Medication | Up to 24 hours postdose | Intent-to-treat (ITT) | Hours | MEDIAN |
| SECONDARY | Cumulative Percentage of Participants Who Took Rescue Medication | At 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdose | Intent-to-treat (ITT) | Percentage of participants | NUMBER |
| SECONDARY | Number of Times the Participants Took Rescue Medication Over the 24-hour Period | 24 hours postdose | Intent-to-treat (ITT) | Rescue medication intakes | MEAN |
| SECONDARY | Global Assessment of the Investigational Product as a Pain Reliever | 24 hours postdose or immediately before the first intake of rescue medication | Intent-to-treat (ITT) | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group183
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Summed, Time-weighted Pain Intensity Difference From 0 to 24 Hours Postdose (SPID0-24) | Naproxen Sodium ER (BAYH6689) | 23.2 | Standard Error 2.01 | Score on the scale | |
| Summed, Time-weighted Pain Intensity Difference From 0 to 24 Hours Postdose (SPID0-24) | Naproxen Sodium IR (Aleve, BAYH6689) | 23.6 | Standard Error 2.01 | Score on the scale | |
| Summed, Time-weighted Pain Intensity Difference From 0 to 24 Hours Postdose (SPID0-24) | Placebo | -0.6 | Standard Error 2.85 | Score on the scale | |
| Summed, Time-weighted Pain Intensity Differences (SPID) | Naproxen Sodium ER (BAYH6689) | From 0 to 6 hours, LS Mean | 5.3 | 95% Confidence Interval 4.5 to 6.7 | Score on the scale |
| Summed, Time-weighted Pain Intensity Differences (SPID) | Naproxen Sodium IR (Aleve, BAYH6689) | From 0 to 6 hours, LS Mean | 5.3 | 95% Confidence Interval 4.5 to 6.1 | Score on the scale |
| Summed, Time-weighted Pain Intensity Differences (SPID) | Placebo | From 0 to 6 hours, LS Mean | -0.5 | 95% Confidence Interval -1.6 to 0.7 | Score on the scale |
| Summed, Time-weighted Pain Intensity Differences (SPID) | Naproxen Sodium ER (BAYH6689) | From 0 to 8 hours, LS Mean | 7.0 | 95% Confidence Interval 5.9 to 8.1 | Score on the scale |
| Summed, Time-weighted Pain Intensity Differences (SPID) | Naproxen Sodium IR (Aleve, BAYH6689) | From 0 to 8 hours, LS Mean | 6.9 | 95% Confidence Interval 5.7 to 8.0 | Score on the scale |
| Summed, Time-weighted Pain Intensity Differences (SPID) | Placebo | From 0 to 8 hours, LS Mean | -0.8 | 95% Confidence Interval -2.3 to 0.8 | Score on the scale |
| Summed, Time-weighted Pain Intensity Differences (SPID) | Naproxen Sodium ER (BAYH6689) | From 0 to 12 hours, LS Mean | 10.9 | 95% Confidence Interval 9.1 to 12.7 | Score on the scale |
1 to 10 of 183Source ClinicalTrials.gov
See all 183 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Naproxen Sodium ER (BAYH6689) | 120 | |
| Overall Study | STARTED | Naproxen Sodium IR (Aleve, BAYH6689) | 120 | |
| Overall Study | STARTED | Placebo | 60 | |
| Overall Study | COMPLETED | Naproxen Sodium ER (BAYH6689) | 120 | |
| Overall Study | COMPLETED | Naproxen Sodium IR (Aleve, BAYH6689) | 120 | |
| Overall Study | COMPLETED | Placebo | 60 | |
| Overall Study | NOT COMPLETED | Naproxen Sodium ER (BAYH6689) | 0 | |
| Overall Study | NOT COMPLETED | Naproxen Sodium IR (Aleve, BAYH6689) | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events96
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Ear pain | Ear and labyrinth disorders | Naproxen Sodium ER (BAYH6689) | 1 | 120 | 1 |
| other | Ear pain | Ear and labyrinth disorders | Naproxen Sodium IR (Aleve, BAYH6689) | 2 | 120 | 2 |
| other | Ear pain | Ear and labyrinth disorders | Placebo | 0 | 60 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Naproxen Sodium ER (BAYH6689) | 1 | 120 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Naproxen Sodium IR (Aleve, BAYH6689) | 1 | 120 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 0 | 60 | 0 |
| other | Mouth ulceration | Gastrointestinal disorders | Naproxen Sodium ER (BAYH6689) | 0 | 120 | 0 |
| other | Mouth ulceration | Gastrointestinal disorders | Naproxen Sodium IR (Aleve, BAYH6689) | 1 | 120 | 1 |
| other | Mouth ulceration | Gastrointestinal disorders | Placebo | 0 | 60 | 0 |
| other | Nausea | Gastrointestinal disorders | Naproxen Sodium ER (BAYH6689) | 10 | 120 | 10 |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Naproxen Sodium ER (BAYH6689) | ||
| Total, all-cause mortality | Naproxen Sodium IR (Aleve, BAYH6689) | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Naproxen Sodium ER (BAYH6689) | 28 | 120 |
| Total, other adverse events | Naproxen Sodium IR (Aleve, BAYH6689) | 36 | 120 |
| Total, other adverse events | Placebo | 23 | 60 |
| Total, serious adverse events | Naproxen Sodium ER (BAYH6689) | 0 | 120 |
| Total, serious adverse events | Naproxen Sodium IR (Aleve, BAYH6689) | 0 | 120 |
| Total, serious adverse events | Placebo | 0 | 60 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26588111 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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