Trial · NCT01455428
Pregabalin for Treatment of Patients With Postherpetic Neuralgia (PHN)
NCT01455428, Phase 4, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2015-05-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pregabalin for Treatment of Patients With Postherpetic Neuralgia (PHN). Trials, record NCT01455428. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01455428
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pregabalin for Treatment of Patients With Postherpetic Neuralgia (PHN)
- NCT number
- NCT01455428
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 223 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Postherpetic Neuralgia ( PHN )
- Interventions
- Lyrica (pregabalin), Placebo
- First posted
- 2011-10-20
- Last updated
- 2021-01-28
- Results first posted
- 2015-05-22
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Baseline Mean Pain Score | Baseline | The daily pain rating scale (DPRS) consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. |
| Primary | Change From Baseline in Mean Pain Score at Endpoint | Baseline until end of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint) | The daily pain rating scale (DPRS) consists of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The mean endpoint pain score was obtained from the last 7 available DPRS scores of the daily pain diary while the participant was on study medication, up to and including the day after the last Week 8 (Day 57) dose. |
| Secondary | Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 8 | Baseline and weekly from Weeks 1 to 8 | The DPRS consists of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The weekly mean pain score was the sum of the daily scores divided by the number of diary entries during that week. |
| Secondary | Baseline Mean Sleep Interference Score | Baseline | Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered \[unable to sleep due to pain\]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. |
| Secondary | Change From Baseline in Mean Sleep Interference Score at Endpoint | Baseline until end of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint) | Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered \[unable to sleep due to pain\]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. The mean endpoint score was obtained from the last 7 available scores of the daily diary while the participant was on study medication, up to and including the day after the last Week 8 (Day 57) dose. |
| Secondary | Change From Baseline in Weekly Mean Sleep Interference Scores at Weeks 1 to 8 | Baseline and weekly from Weeks 1 to 8 | Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered \[unable to sleep due to pain\]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. The weekly mean score was the sum of the daily scores divided by the number of diary entries during that week. |
| Secondary | Percentage of 30 Percent (%) Responders at Endpoint | End of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint) | The DPRS consists of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. A 30% responder was a participant who had 30% reduction or more in mean pain score at the end of the fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint) compared to baseline. |
| Secondary | Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 3, 5, and 8 | Baseline; Weeks 1, 3, 5, and 8 | SF-MPQ was assessed according to the participant's answer to the SF-MPQ questionnaire. The score for each composite scale (sensory, affective, and total) was derived by summing the reported intensity value for each item within a particular scale where None=0, Mild=1, Moderate=2, and Severe=3. The sensory score was the sum of the scores of the first 11 pain descriptors (throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, and splitting) and could range from 0-33. The affective score was the sum of the scores of the last 4 pain descriptors (tiring-exhausting, sickening, fearful, and punishing-cruel) and could range from 0-12. The total score was the sum of the scores of all 15 pain descriptors and could range from 0 to 45. Higher scores indicated greater pain. |
| Secondary | Baseline Pain Visual Analogue Scale (VAS) and Present Pain Intensity (PPI) Scale | Baseline | The VAS was part of the Short Form McGill Pain Questionnaire (SF-MPQ) scale and reflected the overall pain intensity score, The pain VAS was a horizontal line; 100 millimeters (mm) in length, was self-administered by the participant in order to rate pain from 0 (no pain) to 100 (worst possible pain). The PPI was part of the SF-MPQ scale and measured the participant's present pain intensity on a 6-point scale ranging from 0 (no pain) to 5 (excruciating). |
| Secondary | Change From Baseline in Pain VAS From the SF-MPQ at Endpoint | Baseline to Day 57 (Week 8)/Early Termination (Study Endpoint) | The VAS was part of the SF-MPQ scale and reflected the overall pain intensity score. The pain VAS was a horizontal line; 100 mm in length, was self-administered by the participant in order to rate pain from 0 (no pain) to 100 (worst possible pain). |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Baseline Mean Pain Score | Baseline | All participants in the Full Analysis Set (FAS) population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The Last Observation Carried Forward (LOCF) method was used. | units on a scale | MEAN |
| PRIMARY | Change From Baseline in Mean Pain Score at Endpoint | Baseline until end of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint) | All participants in the Full Analysis Set (FAS) population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The Last Observation Carried Forward (LOCF) method was used. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 8 | Baseline and weekly from Weeks 1 to 8 | The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Baseline Mean Sleep Interference Score | Baseline | All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Mean Sleep Interference Score at Endpoint | Baseline until end of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint) | All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Weekly Mean Sleep Interference Scores at Weeks 1 to 8 | Baseline and weekly from Weeks 1 to 8 | The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of 30 Percent (%) Responders at Endpoint | End of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint) | All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 3, 5, and 8 | Baseline; Weeks 1, 3, 5, and 8 | The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication. N=the number of participants who were evaluable for this measure at the given time point. | units on a scale | MEAN |
| SECONDARY | Baseline Pain Visual Analogue Scale (VAS) and Present Pain Intensity (PPI) Scale | Baseline | The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication. The LOCF method was used in the analysis of this outcome measure. Number of participants evaluable for PPI=110, 108 | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Pain VAS From the SF-MPQ at Endpoint | Baseline to Day 57 (Week 8)/Early Termination (Study Endpoint) | All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used. | units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group122
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Baseline Mean Pain Score | Pregabalin | 5.93 | Standard Deviation 1.304 | units on a scale | |
| Baseline Mean Pain Score | Placebo | 6.08 | Standard Deviation 1.266 | units on a scale | |
| Change From Baseline in Mean Pain Score at Endpoint | Pregabalin | -1.81 | Standard Error 0.137 | units on a scale | |
| Change From Baseline in Mean Pain Score at Endpoint | Placebo | -1.09 | Standard Error 0.142 | units on a scale | |
| Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 8 | Pregabalin | Week 1 change from baseline | -0.62 | Standard Error 0.108 | units on a scale |
| Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 8 | Placebo | Week 1 change from baseline | -0.12 | Standard Error 0.111 | units on a scale |
| Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 8 | Pregabalin | Week 2 change from baseline | -1.00 | Standard Error 0.109 | units on a scale |
| Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 8 | Placebo | Week 2 change from baseline | -0.35 | Standard Error 0.112 | units on a scale |
| Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 8 | Pregabalin | Week 3 change from baseline | -1.23 | Standard Error 0.109 | units on a scale |
| Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 8 | Placebo | Week 3 change from baseline | -0.65 | Standard Error 0.112 | units on a scale |
1 to 10 of 122Source ClinicalTrials.gov
See all 122 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pregabalin | 112 | |
| Overall Study | STARTED | Placebo | 110 | |
| Overall Study | Treated | Pregabalin | 111 | |
| Overall Study | Treated | Placebo | 109 | |
| Overall Study | COMPLETED | Pregabalin | 98 | |
| Overall Study | COMPLETED | Placebo | 92 | |
| Overall Study | NOT COMPLETED | Pregabalin | 14 | |
| Overall Study | NOT COMPLETED | Placebo | 18 |
Source ClinicalTrials.gov
Adverse events14
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 | Dry mouth | Gastrointestinal disorders | Pregabalin | 6 | 111 | |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 3 | 109 | |
| other | Oedema peripheral | General disorders | Pregabalin | 7 | 111 | |
| other | Oedema peripheral | General disorders | Placebo | 2 | 109 | |
| other | Nasopharyngitis | Infections and infestations | Pregabalin | 5 | 111 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 9 | 109 | |
| other | Dizziness | Nervous system disorders | Pregabalin | 27 | 111 | |
| other | Dizziness | Nervous system disorders | Placebo | 4 | 109 | |
| other | Somnolence | Nervous system disorders | Pregabalin | 6 | 111 | |
| other | Somnolence | Nervous system disorders | Placebo | 5 | 109 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pregabalin | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Pregabalin | 40 | 111 |
| Total, other adverse events | Placebo | 21 | 109 |
| Total, serious adverse events | Pregabalin | 2 | 111 |
| Total, serious adverse events | Placebo | 0 | 109 |
Source ClinicalTrials.gov
Papers0
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Pregabalin vs Placebo: serious adverse events |
Source Trial comparisons
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01455428
GET https://conductscience.org/api/trials/v1/NCT01455428/registered?page=2