Trial · NCT01270828
Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Postherpetic Neuralgia
NCT01270828, Phase 3, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2016-01-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Postherpetic Neuralgia. Trials, record NCT01270828. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01270828
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Postherpetic Neuralgia
- NCT number
- NCT01270828
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 806 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Post Herpetic Neuralgia
- Interventions
- Pregabalin, placebo
- First posted
- 2011-01-05
- Last updated
- 2021-01-28
- Other registries' IDs
- eudract:2009-016766-86
- Results first posted
- 2016-01-13
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Loss of Therapeutic Response. | 13 Weeks | Loss of Therapeutic Response (LTR) is defined as \<30% pain response relative to the single blind phase baseline or patient discontinuation due to lack of efficacy or adverse events in the double blind phase of the study. For the calculation of \<30% pain response relative to baseline, baseline will be defined as the mean of the last 7 observations prior to the start of SB treatment, which will be compared with the 7 days rolling average of pain response in DB phase. Participants may be discontinued due to lack of efficacy in this study at the discretion of the study physician. |
| Secondary | Participants With Secondary LTR Based on 5 Day Rolling Average Diary Results | 13 Weeks | A secondary LTR endpoint (S-LTR) was defined as the 5 day rolling average pain score during DB, compared to the 5 day randomization baseline pain score. As a secondary endpoint, S-LTR was defined as: 1. At least a 30% increase in the 5 days rolling average pain score during DB relative to the 5 Day randomization baseline pain score 2. A 5 days rolling average pain score ≥4. Participants who discontinue due to lack of efficacy or adverse events in the DB phase of the study will also be counted as an LTR. |
| Secondary | Percentage of Participants With 30% Reduction in the Mean Pain Score. | 13 Weeks | The 30% pain responders were defined as participants with at least a 30% reduction in the mean pain score from SB baseline to DB endpoint. |
| Secondary | Percentage of Participants With 50% Reduction in the Mean Pain Score. | 13 Weeks | The 50% pain responders were defined as participants with at least a 50% reduction in the mean pain score from SB baseline to DB endpoint. |
| Secondary | Change From Baseline to Endpoint in Weekly Mean Pain Score. | SB Baseline (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19 | The pain numeric rating scale (NRS Pain) consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain |
| Secondary | Change in the Weekly NRS-Pain (1-Week Recall). | SB Baseline (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19 | The pain numeric rating scale (NRS Pain) consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain. Participants were asked to rate their pain over the past week. |
| Secondary | Change in the Medical Outcomes Study-Sleep Scale (MOS-SS). | SB Baseline (BL) (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19 | The MOS-SS is a validated self administered questionnaire consisting of 12 items that assess key constructs of sleep. The scale has been found reliable and valid with good overall measurement properties. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9 item overall sleep problems index assessing sleep over the past week. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute. |
| Secondary | Change in the MOS-SS-Quantity of Sleep. | SB Baseline (BL) (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19 | The MOS-SS is a validated self administered questionnaire consisting of 12 items that assess key constructs of sleep. The scale has been found reliable and valid with good overall measurement properties. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9 item overall sleep problems index assessing sleep over the past week. The item "Quantity of sleep" of MOS-SS is presented here. |
| Secondary | The MOS-SS-Optimal Sleep. | Week 6 and Week 19 | The MOS-SS is a validated self administered questionnaire consisting of 12 items that assess key constructs of sleep. The scale has been found reliable and valid with good overall measurement properties. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9 item overall sleep problems index assessing sleep over the past week. The optimal sleep score is a dichotomous 'Yes' or 'No' rating, where 'Yes' indicates optimal sleep (average 7-8 hours per night) and 'No' indicates not optimal sleep. The "percentage of participants with optimal sleep" is presented here. |
| Secondary | Percentage of Participants With Change in the Patient Global Impression of Change (PGIC) Score | Week 19 | The PGIC is a participant-rated instrument that has been used in chronic pain and fibromyalgia studies to rate change in a patient's overall status. This single item instrument uses a 7 point Likert scale, anchored by (1) very much improved, to (7) very much worse. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Loss of Therapeutic Response. | 13 Weeks | The full analysis set (FAS) was the primary efficacy analysis set and consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase. | Participants | NUMBER |
| SECONDARY | Participants With Secondary LTR Based on 5 Day Rolling Average Diary Results | 13 Weeks | The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase | Participants | NUMBER |
| SECONDARY | Percentage of Participants With 30% Reduction in the Mean Pain Score. | 13 Weeks | The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With 50% Reduction in the Mean Pain Score. | 13 Weeks | The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline to Endpoint in Weekly Mean Pain Score. | SB Baseline (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19 | The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in the Weekly NRS-Pain (1-Week Recall). | SB Baseline (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19 | The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in the Medical Outcomes Study-Sleep Scale (MOS-SS). | SB Baseline (BL) (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19 | The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase. N in the below table refers to number of participants analyzed: 203 in Pregabalin DB CR group and 195 in Placebo DB group, unless otherwise specified. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in the MOS-SS-Quantity of Sleep. | SB Baseline (BL) (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19 | The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase. | Hours | LEAST_SQUARES_MEAN |
| SECONDARY | The MOS-SS-Optimal Sleep. | Week 6 and Week 19 | The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Change in the Patient Global Impression of Change (PGIC) Score | Week 19 | The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase. | Percentage of participants | NUMBER |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group153
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Loss of Therapeutic Response. | Pregabalin CR DB | 29 | Participants | ||
| Number of Participants With Loss of Therapeutic Response. | Placebo DB | 63 | Participants | ||
| Participants With Secondary LTR Based on 5 Day Rolling Average Diary Results | Pregabalin CR DB | 49 | Participants | ||
| Participants With Secondary LTR Based on 5 Day Rolling Average Diary Results | Placebo DB | 87 | Participants | ||
| Percentage of Participants With 30% Reduction in the Mean Pain Score. | Pregabalin CR DB | 95.6 | Percentage of participants | ||
| Percentage of Participants With 30% Reduction in the Mean Pain Score. | Placebo DB | 83.8 | Percentage of participants | ||
| Percentage of Participants With 50% Reduction in the Mean Pain Score. | Pregabalin CR DB | 88.3 | Percentage of participants | ||
| Percentage of Participants With 50% Reduction in the Mean Pain Score. | Placebo DB | 68.6 | Percentage of participants | ||
| Change From Baseline to Endpoint in Weekly Mean Pain Score. | Pregabalin CR DB | SB Baseline to Week 19 | -4.89 | Standard Error 0.12 | Units on a scale |
| Change From Baseline to Endpoint in Weekly Mean Pain Score. | Placebo DB | SB Baseline to Week 19 | -3.95 | Standard Error 0.12 | Units on a scale |
1 to 10 of 153Source ClinicalTrials.gov
See all 153 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Pregabalin CR SB | STARTED | Pregabalin Controlled Release (CR) DB | 0 | |
| Pregabalin CR SB | STARTED | Placebo DB | 0 | |
| Pregabalin CR SB | STARTED | Pregabalin CR SB | 806 | |
| Pregabalin CR SB | COMPLETED | Pregabalin Controlled Release (CR) DB | 0 | |
| Pregabalin CR SB | COMPLETED | Placebo DB | 0 | |
| Pregabalin CR SB | COMPLETED | Pregabalin CR SB | 660 | |
| Pregabalin CR SB | NOT COMPLETED | Pregabalin Controlled Release (CR) DB | 0 | |
| Pregabalin CR SB | NOT COMPLETED | Placebo DB | 0 | |
| Pregabalin CR SB | NOT COMPLETED | Pregabalin CR SB | 146 | |
| Double Blind Phase | STARTED | Pregabalin Controlled Release (CR) DB | 208 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events93
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 | Dizziness | Nervous system disorders | Pregabalin CR DB | 7 | 208 | |
| other | Dizziness | Nervous system disorders | Placebo DB | 1 | 205 | |
| other | Dizziness | Nervous system disorders | Pregabalin CR SB | 137 | 801 | |
| other | Somnolence | Nervous system disorders | Pregabalin CR DB | 1 | 208 | |
| other | Somnolence | Nervous system disorders | Placebo DB | 0 | 205 | |
| other | Somnolence | Nervous system disorders | Pregabalin CR SB | 91 | 801 | |
| serious | Anaemia of chronic disease | Blood and lymphatic system disorders | Pregabalin CR DB | 1 | 208 | |
| serious | Anaemia of chronic disease | Blood and lymphatic system disorders | Placebo DB | 0 | 205 | |
| serious | Anaemia of chronic disease | Blood and lymphatic system disorders | Pregabalin CR SB | 0 | 801 | |
| serious | Thrombocytopenia | Blood and lymphatic system disorders | Pregabalin CR DB | 0 | 208 |
1 to 10 of 93Source ClinicalTrials.gov
See all 93 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pregabalin CR DB | ||
| Total, all-cause mortality | Placebo DB | ||
| Total, all-cause mortality | Pregabalin CR SB | ||
| Total, other adverse events | Pregabalin CR DB | 7 | 208 |
| Total, other adverse events | Placebo DB | 1 | 205 |
| Total, other adverse events | Pregabalin CR SB | 202 | 801 |
| Total, serious adverse events | Pregabalin CR DB | 7 | 208 |
| Total, serious adverse events | Placebo DB | 3 | 205 |
| Total, serious adverse events | Pregabalin CR SB | 17 | 801 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27753650 | 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Pregabalin CR DB vs Placebo DB: Participants With Secondary LTR Based on 5 Day Rolling Average Diary Results | Trial comparisons |
| Pregabalin CR DB vs Placebo DB: Number of Participants With Loss of Therapeutic Response. | 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.
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