Trial · NCT01049217
Pregabalin Versus Placebo In The Treatment Of Neuropathic Pain Associated With HIV Neuropathy
NCT01049217, Phase 3, Terminated, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2013-07-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pregabalin Versus Placebo In The Treatment Of Neuropathic Pain Associated With HIV Neuropathy. Trials, record NCT01049217. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01049217
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pregabalin Versus Placebo In The Treatment Of Neuropathic Pain Associated With HIV Neuropathy
- NCT number
- NCT01049217
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 377 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Neuropathy
- Interventions
- pregabalin, placebo
- First posted
- 2010-01-14
- Last updated
- 2021-01-28
- Results first posted
- 2013-07-17
- Limitations and caveats
Based on Data Monitoring Committee (DMC) interim efficacy analysis results indicating a low probability for success, the study was terminated on April 2, 2012; the termination was unrelated to any safety findings that could impact participant health.
Source ClinicalTrials.gov
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Mean Pain Score at Endpoint (up to Week 16) | Baseline, Endpoint (up to Week 16) | Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their Human Immunodeficiency Virus (HIV) neuropathy pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Endpoint was the last observation for a participant assessed using specified imputation method, modified Baseline Observation Carried Forward (mBOCF). |
| Secondary | Number of Participants With Categorical Scores on Patient Global Impression of Change (PGIC) | Week 16 | PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category is reported. |
| Secondary | Number of Participants With Categorical Scores on Clinician Global Impression of Change (CGIC) | Week 16 | The CGIC scale measures a physician's global impression of a participant's clinical condition at final visit in terms of change relative to the start of treatment (CGIC). At final visit, the participants CGIC will be categorized into a three point scale as: improvement: CGI response of very much improved, much improved or minimally improved; no change: CGI response of no change; worsening: CGI response of very much worse, much worse or minimally worse. Number of participants in each category is reported. |
| Secondary | Change From Baseline in Numeric Rating Scale (NRS)-Sleep Interference Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16) | Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, Endpoint (up to Week 16) | Weekly mean sleep interference score was defined as the mean of the daily sleep interference diary ratings split into 7 day intervals. Participants rated how HIV neuropathy pain has interfered with their sleep during the past 24 hours on an 11-point NRS ranging from 0 = does not interfere with sleep to 10 = completely interferes (unable to sleep due to pain). Endpoint was the last observation for a participant assessed using specified imputation method. |
| Secondary | Change From Baseline in Numeric Rating Scale (NRS)-Current Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16) | Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, Endpoint (up to Week 16) | Weekly current pain score was defined as the mean of the daily current pain diary ratings split into 7 day intervals. Participants rated current ("right now") HIV neuropathy pain an 11-point NRS ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Endpoint was the last observation for a participant assessed using specified imputation method. |
| Secondary | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score at Week 4, 8, 12, 16 and Endpoint (up to Week 16) | Baseline, Week 4, 8, 12, 16, Endpoint (up to Week 16) | BPI-sf:5-item self-administered questionnaire to assess severity,impact of pain on daily functions. Pain Severity Index (PSI):average of Question 1-4 each measured severity of pain over past 24-hours on 11-point scale (0=no pain to 10=worst possible pain). Pain Interference Index (PII):average of 7 pain interference items of Question 5 that measured level of interference of pain on daily function on 11-point scale (0=does not interfere to 10=completely interferes). For PSI, PII range:0-10 higher score=higher pain/interference. Endpoint=last observation for participant as per imputation method. |
| Secondary | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Item Scores at Endpoint (up to Week 16) | Baseline, Endpoint (up to Week 16) | NPSI: participant-rated questionnaire to evaluate different symptoms of neuropathic pain. It includes 10 descriptors and 2 temporal items. Results reported for the 10 descriptors (burning, squeezing, pressure, electric shocks, stabbing, light touching of area, pressure of area, cold of area, pins and needles, tingling) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) scale. Endpoint was the last observation for a participant assessed using specified imputation method. |
| Secondary | Neuropathic Pain Symptom Inventory (NPSI): Change From Baseline in Number of Participants With Duration of Spontaneous Pain and Number of Pain Attacks at Endpoint (up to Week 16) | Baseline, Endpoint (up to Week 16) | NPSI: participant-rated questionnaire to evaluate different symptoms of neuropathic pain. It includes 10 descriptors, and 2 temporal items. Results reported for categorical change in temporal items assessed on 5-point scale for duration of spontaneous pain (1=continuously, 2=8-12 hours \[hrs\], 3=4-7 hrs, 4=1-3 hrs, 5=less than 1 hr), numbers of pain attacks (1=more than 20, 2=11-20 attacks, 3=6-10 attacks, 4=1-5 attacks, 5=no attack). Change data categorized as worsened (negative change), unchanged (no change), and improved (positive change). Endpoint=last observation as per imputation method. |
| Secondary | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Subscales and Total Intensity Score at Endpoint (up to Week 16) | Baseline, Endpoint (up to Week 16) | NPSI: participant rated questionnaire to evaluate different symptoms of neuropathic pain (subscales: burning \[superficial\] spontaneous pain, pressing \[deep\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia \[P/D\]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. The relevant subscales and total score were transformed to 0-1, higher score indicates a greater intensity of pain. Endpoint=last observation for participant as per imputation method. |
| Secondary | Total Sleep Time (TST) and Minutes of Interrupted Sleep (MIS) | Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16) | Total sleep time is the number of minutes asleep between time of sleep onset to morning awakening and MIS is the number of minutes spent awake after sleep onset to final awakening. TST and MIS were determined by actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to record movements while the device was being worn. Endpoint was the last observation for a participant assessed using specified imputation method. |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 registered outcomesOutcomes33
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Mean Pain Score at Endpoint (up to Week 16) | Baseline, Endpoint (up to Week 16) | Intent to Treat (ITT) population: all randomized participants who took at least 1 dose of study drug. Imputation: mBOCF, baseline data was carried forward for participants who discontinued due to adverse events or had no post-baseline observations; otherwise last observation carried forward (LOCF). | units on a scale | MEAN |
| SECONDARY | Number of Participants With Categorical Scores on Patient Global Impression of Change (PGIC) | Week 16 | ITT population: all randomized participants who took at least 1 dose of study drug. N (number of participants analyzed) signifies those participants who were evaluable for this measure. | participants | NUMBER |
| SECONDARY | Number of Participants With Categorical Scores on Clinician Global Impression of Change (CGIC) | Week 16 | ITT population: all randomized participants who took at least 1 dose of study drug. N (number of participants analyzed) signifies those participants who were evaluable for this measure. | participants | NUMBER |
| SECONDARY | Change From Baseline in Numeric Rating Scale (NRS)-Sleep Interference Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16) | Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, Endpoint (up to Week 16) | ITT population: all randomized participants who took at least 1 dose of study drug. N (number of participants analyzed) signifies those participants who were evaluable for this measure. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Numeric Rating Scale (NRS)-Current Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16) | Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, Endpoint (up to Week 16) | ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score at Week 4, 8, 12, 16 and Endpoint (up to Week 16) | Baseline, Week 4, 8, 12, 16, Endpoint (up to Week 16) | ITT population: all randomized participants who took at least 1 dose of study drug. N (number of participants analyzed) signifies those participants who were evaluable for this measure. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Item Scores at Endpoint (up to Week 16) | Baseline, Endpoint (up to Week 16) | ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF. | units on a scale | MEAN |
| SECONDARY | Neuropathic Pain Symptom Inventory (NPSI): Change From Baseline in Number of Participants With Duration of Spontaneous Pain and Number of Pain Attacks at Endpoint (up to Week 16) | Baseline, Endpoint (up to Week 16) | ITT population: all randomized participants who took at least 1 dose of study drug. N (number of participants analyzed) signifies those participants who were evaluable for this measure. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF. | participants | NUMBER |
| SECONDARY | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Subscales and Total Intensity Score at Endpoint (up to Week 16) | Baseline, Endpoint (up to Week 16) | ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF. | units on a scale | MEAN |
| SECONDARY | Total Sleep Time (TST) and Minutes of Interrupted Sleep (MIS) | Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16) | ITT population. N (number of participants analyzed) = participants evaluable for this measure. Missing data for endpoint (up to Week 16) imputed using LOCF. Data for Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16 were collected and reported in individual participant listings but not statistically summarized for analysis. | minutes | LEAST_SQUARES_MEAN |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 outcomesResults by group756
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Mean Pain Score at Endpoint (up to Week 16) | Pregabalin | Baseline | 6.76 | Standard Deviation 1.194 | units on a scale |
| Change From Baseline in Mean Pain Score at Endpoint (up to Week 16) | Placebo | Baseline | 6.85 | Standard Deviation 1.222 | units on a scale |
| Change From Baseline in Mean Pain Score at Endpoint (up to Week 16) | Pregabalin | Change at Endpoint | -2.26 | Standard Deviation 2.200 | units on a scale |
| Change From Baseline in Mean Pain Score at Endpoint (up to Week 16) | Placebo | Change at Endpoint | -2.36 | Standard Deviation 2.288 | units on a scale |
| Number of Participants With Categorical Scores on Patient Global Impression of Change (PGIC) | Pregabalin | Very Much Improved | 42 | participants | |
| Number of Participants With Categorical Scores on Patient Global Impression of Change (PGIC) | Placebo | Very Much Improved | 51 | participants | |
| Number of Participants With Categorical Scores on Patient Global Impression of Change (PGIC) | Pregabalin | Much Improved | 69 | participants | |
| Number of Participants With Categorical Scores on Patient Global Impression of Change (PGIC) | Placebo | Much Improved | 66 | participants | |
| Number of Participants With Categorical Scores on Patient Global Impression of Change (PGIC) | Pregabalin | Minimally Improved | 42 | participants | |
| Number of Participants With Categorical Scores on Patient Global Impression of Change (PGIC) | Placebo | Minimally Improved | 36 | participants |
1 to 10 of 756Source ClinicalTrials.gov
See all 756 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 | 183 | |
| Overall Study | STARTED | Placebo | 194 | |
| Overall Study | Treated | Pregabalin | 183 | |
| Overall Study | Treated | Placebo | 192 | |
| Overall Study | COMPLETED | Pregabalin | 127 | |
| Overall Study | COMPLETED | Placebo | 131 | |
| Overall Study | NOT COMPLETED | Pregabalin | 56 | |
| Overall Study | NOT COMPLETED | Placebo | 63 |
Source ClinicalTrials.gov
Adverse events38
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 | Influenza | Infections and infestations | Pregabalin | 17 | 183 | |
| other | Influenza | Infections and infestations | Placebo | 12 | 192 | |
| other | Dizziness | Nervous system disorders | Pregabalin | 25 | 183 | |
| other | Dizziness | Nervous system disorders | Placebo | 10 | 192 | |
| other | Headache | Nervous system disorders | Pregabalin | 25 | 183 | |
| other | Headache | Nervous system disorders | Placebo | 26 | 192 | |
| other | Somnolence | Nervous system disorders | Pregabalin | 13 | 183 | |
| other | Somnolence | Nervous system disorders | Placebo | 4 | 192 | |
| serious | Diarrhoea | Gastrointestinal disorders | Pregabalin | 1 | 183 | |
| serious | Diarrhoea | Gastrointestinal disorders | Placebo | 1 | 192 |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 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 | 64 | 183 |
| Total, other adverse events | Placebo | 47 | 192 |
| Total, serious adverse events | Pregabalin | 7 | 183 |
| Total, serious adverse events | Placebo | 7 | 192 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24907403 | 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 vs Placebo: Number of Participants With Abnormal Laboratory Test Findings | Trial comparisons |
| Pregabalin vs Placebo: serious adverse events | 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/NCT01049217
GET https://conductscience.org/api/trials/v1/NCT01049217/registered?page=2