Phase 3
N=302
Study of Pregabalin Versus Placebo in the Treatment of Nerve Pain Associated With HIV Neuropathy
HIV Infections · Peripheral Neuropathy
Bottom Line
View on ClinicalTrials.gov: NCT00232141 ↗Enrolled (actual)
302
Serious AEs
—
Results posted
Aug 2009
Primary outcome: Primary: Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline — -2.88; -2.63 score on scale — p=0.3914
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- pregabalin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Nov 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline |
-2.88; -2.63 | 0.3914 |
| SECONDARY Change From Baseline for MOS (Medical Outcomes Study)-Sleep Subscales and Sleep Problem Indices |
-13.17; -14.71; 0.39; 0.65; 10.04; 10.09 | 0.5425 |
| SECONDARY Change From Baseline for Hospital Anxiety and Depression Scale (HADS) Subscales |
-1.33; -1.59; -1.10; -1.52 | 0.5105 |
| SECONDARY Change From Baseline for Modified Brief Pain Inventory-Short Form (mBPI-sf) Scores |
-2.42; -2.56; -2.32; -2.39 | 0.5834 |
| SECONDARY Change From Baseline for NRS-Sleep Interference Scores |
-2.53; -2.34 | 0.4776 |
| SECONDARY Categorized Patient Global Impression of Change (PGIC) |
106; 84; 17; 32; 5; 10 | 0.0077 sig |
| SECONDARY Patient Global Impression of Change (PGIC) Rating |
27; 27; 41; 38; 38; 19 | 0.3852 |
| SECONDARY Change in Neuropathic Pain Symptom Inventory (NPSI) Subscores and Total Intensity Scores |
-0.19; -0.22; -0.17; -0.15; -0.16; -0.17 | 0.3097 |
| SECONDARY Change in Quantitative Assessment of Neuropathic Pain (QANeP) |
-1.11; -1.22; -0.99; -0.77; -0.78; -0.68 | 0.6865 |
| SECONDARY Change in NRS-Sleep Interference Scores |
-1.04; -0.68; -1.99; -1.36; -2.26; -1.68 | 0.0469 sig |
| SECONDARY Shift in Hospital Anxiety and Depression (HADS) Subscales |
47; 55; 7; 6; 2; 2 | — |
| SECONDARY Change in Brief Pain Inventory-short Form (BPI-sf) Scores (The Worst Pain in the Past 24 Hours) |
-1.52; -1.09; -2.18; -2.20; -3.08; -2.95 | 0.0685 |
| SECONDARY Change in Brief Pain Inventory-sf Scores (The Least Pain in the Past 24 Hours) |
-0.84; -0.80; -1.49; -1.44; -2.37; -2.05 | 0.8605 |
| SECONDARY Change in Brief Pain Inventory-sf Scores (Average Level of Pain in the Past 24 Hours) |
-1.15; -0.90; -1.79; -1.77; -2.64; -2.55 | 0.2390 |
| SECONDARY Change in Brief Pain Inventory-sf Scores (How Much Pain Are You Having Right Now) |
-1.56; -1.01; -2.02; -1.98; -2.66; -2.66 | 0.0202 sig |
| SECONDARY Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your General Activity) |
-1.35; -1.04; -1.95; -1.87; -2.37; -2.25 | 0.2352 |
| SECONDARY Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Mood) |
-1.58; -1.20; -2.23; -2.06; -2.60; -2.41 | 0.1863 |
| SECONDARY Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Walking Ability) |
-1.40; -1.23; -1.84; -1.84; -2.44; -2.33 | 0.5493 |
| SECONDARY Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Normal Work Including Both Work Outside the Home and Housework) |
-1.47; -1.42; -2.10; -1.99; -2.54; -2.45 | 0.8727 |
| SECONDARY Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Relations With Other People) |
-1.06; -0.87; -1.54; -1.39; -1.91; -1.67 | 0.4991 |
| SECONDARY Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Sleep) |
-1.80; -1.12; -2.22; -1.86; -3.06; -2.68 | 0.0073 sig |
| SECONDARY Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Enjoyment of Life) |
-1.52; -1.20; -2.20; -2.13; -2.69; -2.64 | 0.2277 |
| SECONDARY Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain |
15; 21; 11; 5; 8; 6 | — |
| SECONDARY Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks |
4; 6; 2; 4; 1; 4 | — |
| SECONDARY Change in Number of Pain Attacks Compared to Baseline - NPSI (Neuropathic Pain Symptom Inventory) |
65; 66; 35; 32; 19; 21 | 0.7136 |
| SECONDARY Duration of Spontaneous Pain-NPSI (Neuropathic Pain Symptom Inventory) |
63; 60; 46; 40; 19; 26 | 0.6729 |
| SECONDARY Gracely Pain Scale Score |
-2.70; -2.76 | — |
| SECONDARY Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table |
0; 0; 0; 1; 0; 3 | — |
| SECONDARY Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table |
0; 0; 1; 3; 5; 3 | — |
Summary
Study to determine if pregabalin is more effective than placebo in treating subjects with nerve pain associated with HIV neuropathy.
Eligibility Criteria
Inclusion Criteria
- Subjects with confirmed diagnosis of HIV infection
- HIV-associated neuropathic pain (nerve pain) for at least 3 months prior to study start
- subjects with moderate to severe pain
- subjects on stable HIV and pain medications (some medications are not allowed to be taken while participating in the study).
Exclusion Criteria
- Pregnant or breast feeding females
- subjects using street drugs or alcohol abusers during the study
- subject's on anti-diabetic medications
- use of neuroregenerative agents or neurotoxic chemotherapeutic agents 3 months prior to study start and throughout the study
- use of neurotoxic drugs (other than D-drugs) within a month prior to study start and throughout the study.
Data sourced from ClinicalTrials.gov (NCT00232141). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.