Trial · NCT03714672
Tramadol/Diclofenac Fixed-dose Combination Phase III Trial in Acute Pain After Third Molar Extraction
NCT03714672, Phase 3, Completed, Grünenthal GmbH; results first posted 2019-07-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Tramadol/Diclofenac Fixed-dose Combination Phase III Trial in Acute Pain After Third Molar Extraction. Trials, record NCT03714672. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03714672
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tramadol/Diclofenac Fixed-dose Combination Phase III Trial in Acute Pain After Third Molar Extraction
- NCT number
- NCT03714672
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,151 participants, actual
- Lead sponsor
- Grünenthal GmbH
- Conditions
- Acute Pain
- Interventions
- Tramadol/Diclofenac 50/50, Tramadol/Diclofenac 25/25, Tramadol 50, Diclofenac 50
- First posted
- 2018-10-22
- Last updated
- 2019-07-24
- Results first posted
- 2019-07-24
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pain Relief Expressed as Total Pain Relief (TOTPAR) Over the 4 Hours Post-dose Period (TOTPAR4) | Up to 4 hours after first dose | Pain relief was assessed by the participant at defined time points after the first IMP dose using a 5-point verbal rating scale (VRS) with categories 0 (none), 1 (a little), 2 (some), 3 (a lot), or 4 (complete). Total Pain Relief (TOTPAR4) is a time-weighted summary measure of the total area under the pain relief curve that integrates serial assessments of a participant's pain over the duration of 4 hours after IMP intake. Minimum and maximum values for TOTPAR4 were 0=worst score and 16=best score, a higher score indicates more pain relief. |
| Secondary | Total Pain Relief at 6 Hours Post-dose (TOTPAR6) | Up to 6 hours after first dose | Pain relief was assessed by the participant at defined time points after the first IMP dose using a 5-point VRS with categories 0 (none), 1 (a little), 2 (some), 3 (a lot), or 4 (complete). Total Pain Relief (TOTPAR6) is a time-weighted summary measure of the total area under the pain relief curve that integrates serial assessments of a participant's pain over the duration of 6 hours after IMP intake. Minimum and maximum values for TOTPAR6 were 0=worst score and 24=best score, a higher score indicates more pain relief. |
| Secondary | Total Pain Relief at 8 Hours Post-dose (TOTPAR8) | Up to 8 hours after first dose | Pain relief was assessed by the participant at defined time points after the first IMP dose using a 5-point VRS with categories 0 (none), 1 (a little), 2 (some), 3 (a lot), or 4 (complete). Total Pain Relief (TOTPAR8) is a time-weighted summary measure of the total area under the pain relief curve that integrates serial assessments of a participant's pain over the duration of 8 hours after IMP intake. Minimum and maximum values for TOTPAR8 were 0=worst score and 32=best score, a higher score indicates more pain relief. |
| Secondary | Summed Pain Intensity Difference (SPID) at 4, 6, 8, and 24 Hours Post-dose | Baseline; up to 24 hours after first dose | Pain intensity was assessed by the participant before and at defined time points after the first IMP dose using an 11-point NRS with anchors at 0 for "no pain" and 10 for "pain as bad as you can imagine". Pain Intensity Difference (PIDt) was defined as the difference between baseline pain intensity and pain intensity at time point t, and SPID defined as summed PIDt x \[time (hours) elapsed since previous observation\]. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain \[maximum=10 at each time point\], and negative numbers indicate an increase in pain \[minimum=-10 at each time point\]. The overall minimum and maximum are -10 and 10 times the number of hours specified (SPID-4=\[-40 to 40\], SPID-6=\[-60 to 60\], SPID-8=\[-80 to 80\], and SPID-24=\[-240 to 240\]). |
| Secondary | Time to Achieve a 50 Percent Reduction in Baseline Pain (Pain at Least Half Gone) | Up to 24 hours after first dose | Time (hours) when the participant achieved a 50 percent reduction of baseline (starting) pain. It was assessed at defined time points after the first IMP dose using a YES or NO question for pain half gone. |
| Secondary | Time to Onset of First Perceptible Pain Relief | Up to 8 hours after first dose | Participants used one stopwatch to document the time between first IMP dose and when they begin to feel any pain-relieving effect from the IMP. |
| Secondary | Time to Onset of Meaningful Pain Relief | Up to 8 hours after first dose | Participants used a second stopwatch to document the time between first IMP dose and when they felt their pain relief was meaningful to them. |
| Secondary | Time to Intake of First Rescue Medication Dose | First dose to 24 hours after first dose | The time from first IMP dose to first dose of rescue medication (ibuprofen or ketorolac), if needed, within 24 hours post-dose was calculated. |
| Secondary | Subject's Global Evaluation of the Treatment | 8 hours after the first dose of IMP or before first intake of rescue medication (whatever the first) and 24 hours after the first dose of IMPs | Participants documented their overall impression of the analgesic efficacy of the IMPs on a 5-point Likert scale from Excellent (4) to Poor (0). |
| Secondary | Incidence and Type of Adverse Events | Day 1 to Day 14 | The incidence of treatment emergent adverse events (TEAE) reported from first dose (Day 1) to last scheduled contact with the participant on Day 14 was descriptively summarized. Selected TEAEs were events with preferred terms of nausea, vomiting, abdominal pain, gastrointestinal bleeding, dizziness, or hypotension. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pain Relief Expressed as Total Pain Relief (TOTPAR) Over the 4 Hours Post-dose Period (TOTPAR4) | Up to 4 hours after first dose | Full Analysis Set | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Total Pain Relief at 6 Hours Post-dose (TOTPAR6) | Up to 6 hours after first dose | Full Analysis Set | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Total Pain Relief at 8 Hours Post-dose (TOTPAR8) | Up to 8 hours after first dose | Full Analysis Set | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Summed Pain Intensity Difference (SPID) at 4, 6, 8, and 24 Hours Post-dose | Baseline; up to 24 hours after first dose | Full Analysis Set | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Time to Achieve a 50 Percent Reduction in Baseline Pain (Pain at Least Half Gone) | Up to 24 hours after first dose | Full Analysis Set | hours | MEAN |
| SECONDARY | Time to Onset of First Perceptible Pain Relief | Up to 8 hours after first dose | Full Analysis Set | hours | MEAN |
| SECONDARY | Time to Onset of Meaningful Pain Relief | Up to 8 hours after first dose | Full Analysis Set | hours | MEAN |
| SECONDARY | Time to Intake of First Rescue Medication Dose | First dose to 24 hours after first dose | Full Analysis Set | hours | MEAN |
| SECONDARY | Subject's Global Evaluation of the Treatment | 8 hours after the first dose of IMP or before first intake of rescue medication (whatever the first) and 24 hours after the first dose of IMPs | Full Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence and Type of Adverse Events | Day 1 to Day 14 | Safety Set | participants | NUMBER |
Source ClinicalTrials.gov
Results by group124
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pain Relief Expressed as Total Pain Relief (TOTPAR) Over the 4 Hours Post-dose Period (TOTPAR4) | Tramadol/Diclofenac 50/50 | 9.9 | 95% Confidence Interval 9.3 to 10.4 | units on a scale | |
| Pain Relief Expressed as Total Pain Relief (TOTPAR) Over the 4 Hours Post-dose Period (TOTPAR4) | Tramadol/Diclofenac 25/25 | 8.6 | 95% Confidence Interval 8.0 to 9.1 | units on a scale | |
| Pain Relief Expressed as Total Pain Relief (TOTPAR) Over the 4 Hours Post-dose Period (TOTPAR4) | Tramadol 50 | 5.4 | 95% Confidence Interval 4.9 to 5.9 | units on a scale | |
| Pain Relief Expressed as Total Pain Relief (TOTPAR) Over the 4 Hours Post-dose Period (TOTPAR4) | Diclofenac 50 | 5.8 | 95% Confidence Interval 5.3 to 6.3 | units on a scale | |
| Total Pain Relief at 6 Hours Post-dose (TOTPAR6) | Tramadol/Diclofenac 50/50 | 15.2 | 95% Confidence Interval 14.4 to 16.0 | units on a scale | |
| Total Pain Relief at 6 Hours Post-dose (TOTPAR6) | Tramadol/Diclofenac 25/25 | 13.3 | 95% Confidence Interval 12.5 to 14.2 | units on a scale | |
| Total Pain Relief at 6 Hours Post-dose (TOTPAR6) | Tramadol 50 | 9.3 | 95% Confidence Interval 8.4 to 10.1 | units on a scale | |
| Total Pain Relief at 6 Hours Post-dose (TOTPAR6) | Diclofenac 50 | 9.8 | 95% Confidence Interval 9.0 to 10.6 | units on a scale | |
| Total Pain Relief at 8 Hours Post-dose (TOTPAR8) | Tramadol/Diclofenac 50/50 | 20.1 | 95% Confidence Interval 19.0 to 21.2 | units on a scale | |
| Total Pain Relief at 8 Hours Post-dose (TOTPAR8) | Tramadol/Diclofenac 25/25 | 17.8 | 95% Confidence Interval 16.7 to 18.9 | units on a scale |
1 to 10 of 124Source ClinicalTrials.gov
See all 124 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tramadol/Diclofenac 50/50 | 209 | |
| Overall Study | STARTED | Tramadol/Diclofenac 25/25 | 206 | |
| Overall Study | STARTED | Tramadol 50 | 206 | |
| Overall Study | STARTED | Diclofenac 50 | 208 | |
| Overall Study | Safety Set | Tramadol/Diclofenac 50/50 | 208 | |
| Overall Study | Safety Set | Tramadol/Diclofenac 25/25 | 205 | |
| Overall Study | Safety Set | Tramadol 50 | 206 | |
| Overall Study | Safety Set | Diclofenac 50 | 207 | |
| Overall Study | COMPLETED | Tramadol/Diclofenac 50/50 | 207 | |
| Overall Study | COMPLETED | Tramadol/Diclofenac 25/25 | 202 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events232
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 | Palpitations | Cardiac disorders | Tramadol/Diclofenac 50/50 | 0 | 208 | 0 |
| other | Palpitations | Cardiac disorders | Tramadol/Diclofenac 25/25 | 1 | 205 | 1 |
| other | Palpitations | Cardiac disorders | Tramadol 50 | 1 | 206 | 1 |
| other | Palpitations | Cardiac disorders | Diclofenac 50 | 0 | 207 | 0 |
| other | Ear pain | Ear and labyrinth disorders | Tramadol/Diclofenac 50/50 | 0 | 208 | 0 |
| other | Ear pain | Ear and labyrinth disorders | Tramadol/Diclofenac 25/25 | 0 | 205 | 0 |
| other | Ear pain | Ear and labyrinth disorders | Tramadol 50 | 1 | 206 | 1 |
| other | Ear pain | Ear and labyrinth disorders | Diclofenac 50 | 0 | 207 | 0 |
| other | Tinnitus | Ear and labyrinth disorders | Tramadol/Diclofenac 50/50 | 1 | 208 | 1 |
| other | Tinnitus | Ear and labyrinth disorders | Tramadol/Diclofenac 25/25 | 0 | 205 | 0 |
1 to 10 of 232Source ClinicalTrials.gov
See all 232 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tramadol/Diclofenac 50/50 | 0 | 208 |
| Total, all-cause mortality | Tramadol/Diclofenac 25/25 | 0 | 205 |
| Total, all-cause mortality | Tramadol 50 | 0 | 206 |
| Total, all-cause mortality | Diclofenac 50 | 0 | 207 |
| Total, other adverse events | Tramadol/Diclofenac 50/50 | 96 | 208 |
| Total, other adverse events | Tramadol/Diclofenac 25/25 | 62 | 205 |
| Total, other adverse events | Tramadol 50 | 105 | 206 |
| Total, other adverse events | Diclofenac 50 | 48 | 207 |
| Total, serious adverse events | Tramadol/Diclofenac 50/50 | 0 | 208 |
| Total, serious adverse events | Tramadol/Diclofenac 25/25 | 1 | 205 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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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