Study of Pregabalin Versus Placebo in the Treatment of Nerve Pain Associated With HIV Neuropathy

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
43 centers in the United States; Study Initiation and Completion Dates: 6 October 2005 to 27 November 2007

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 472 subjects were screened for the study, and 302 subjects were randomized to study treatment.

Reporting Groups

	Description
Pregabalin	Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
Placebo	Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.

Participant Flow:   Overall Study

	Pregabalin	Placebo
STARTED	151	151
COMPLETED	120	125
NOT COMPLETED	31	26
Adverse Event	9	4
Lack of Efficacy	0	3
Lost to Follow-up	9	6
Unknown	8	10
Withdrawal by Subject	5	3

Reporting Groups

	Description
Pregabalin	Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
Placebo	Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Total	Total of all reporting groups

Baseline Measures

	Pregabalin	Placebo	Total
Number of Participants   [units: participants]	151	151	302
Age   [units: years] Mean ± Standard Deviation	48.2  ± 8.1	46.8  ± 7.5	47.5  ± 7.8
Gender   [units: participants]
Female	26	31	57
Male	125	120	245

1.  Primary:

Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline   [ Time Frame: Baseline, Week 14 ]

2.  Secondary:

Change From Baseline for MOS (Medical Outcomes Study)-Sleep Subscales and Sleep Problem Indices   [ Time Frame: Baseline, Week 14 ]

3.  Secondary:

Change From Baseline for Hospital Anxiety and Depression Scale (HADS) Subscales   [ Time Frame: Baseline, Week 14 ]

4.  Secondary:

Change From Baseline for Modified Brief Pain Inventory-Short Form (mBPI-sf) Scores   [ Time Frame: Baseline, Week 14 ]

5.  Secondary:

Change From Baseline for NRS-Sleep Interference Scores   [ Time Frame: Baseline, Week 14 ]

6.  Secondary:

Categorized Patient Global Impression of Change (PGIC)   [ Time Frame: Baseline, Week 14 ]

7.  Secondary:

Patient Global Impression of Change (PGIC) Rating   [ Time Frame: Baseline, Week 14, Endpoint-LOCF ]

8.  Secondary:

Change in Neuropathic Pain Symptom Inventory (NPSI) Subscores and Total Intensity Scores   [ Time Frame: Baseline, Week 14 ]

9.  Secondary:

Change in Quantitative Assessment of Neuropathic Pain (QANeP)   [ Time Frame: Baseline, Week 14 ]

10.  Secondary:

Change in NRS-Sleep Interference Scores   [ Time Frame: Baseline, Weeks 1-14 ]

11.  Secondary:

Shift in Hospital Anxiety and Depression (HADS) Subscales   [ Time Frame: Baseline, Week 14 ]

12.  Secondary:

Change in Brief Pain Inventory-short Form (BPI-sf) Scores (The Worst Pain in the Past 24 Hours)   [ Time Frame: Baseline, Weeks 1,2,6,10,14, Endpoint - LOCF ]

13.  Secondary:

Change in Brief Pain Inventory-sf Scores (The Least Pain in the Past 24 Hours)   [ Time Frame: Baseline, Weeks 1,2,6,10,14, Endpoint-LOCF ]

14.  Secondary:

Change in Brief Pain Inventory-sf Scores (Average Level of Pain in the Past 24 Hours)   [ Time Frame: Baseline, Weeks 1,2,6,10,14 and Endpoint ]

15.  Secondary:

Change in Brief Pain Inventory-sf Scores (How Much Pain Are You Having Right Now)   [ Time Frame: Baseline, Weeks 1,2,6,10,14 and Endpoint ]

16.  Secondary:

Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your General Activity)   [ Time Frame: Baseline, Weeks 1,2,6,10,14 and Endpoint ]

17.  Secondary:

Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Mood)   [ Time Frame: Baseline, Weeks 1,2,6,10,14 and Endpoint ]

18.  Secondary:

Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Walking Ability)   [ Time Frame: Baseline, Weeks 1,2,6,10,14 and Endpoint ]

19.  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)   [ Time Frame: Baseline, Weeks 1,2,6,10,14 and Endpoint ]

20.  Secondary:

Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Relations With Other People)   [ Time Frame: Baseline, Weeks 1,2,6,10,14 and Endpoint ]

21.  Secondary:

Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Sleep)   [ Time Frame: Baseline, Weeks 1,2,6,10,14 and Endpoint ]

22.  Secondary:

Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Enjoyment of Life)   [ Time Frame: Baseline, Weeks 1,2,6,10,14 and Endpoint ]

23.  Secondary:

Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain   [ Time Frame: Baseline-Week 14 (Endpoint) ]

24.  Secondary:

Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks   [ Time Frame: Baseline-Week 14 (Endpoint) ]

25.  Secondary:

Change in Number of Pain Attacks Compared to Baseline - NPSI (Neuropathic Pain Symptom Inventory)   [ Time Frame: Baseline, Week 14 ]

26.  Secondary:

Duration of Spontaneous Pain-NPSI (Neuropathic Pain Symptom Inventory)   [ Time Frame: Baseline, Week 14 ]

27.  Secondary:

Gracely Pain Scale Score   [ Time Frame: Week 14 ]

28.  Secondary:

Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table   [ Time Frame: Baseline-Week 14 (Endpoint) ]

29.  Secondary:

Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table   [ Time Frame: Baseline-Week 14 (Endpoint) ]

30.  Other Pre-specified:

Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward)   [ Time Frame: Baseline, Weeks 1 - 14 and Endpoint-BOCF ]

31.  Other Pre-specified:

Responders- Decreases of at Least 50% in Mean Weekly Pain Score   [ Time Frame: Weeks 1-14 Endpoint BOCF (modified baseline observation carried forward) ]

32.  Other Pre-specified:

Responders - Decreases of at Least 30% in Mean Weekly Pain Score   [ Time Frame: Weeks 1-14 endpoint BOCF ]

33.  Other Pre-specified:

Duration Adjusted Average Change From Baseline in NRS Pain Scores   [ Time Frame: Weekly: Week 1 - Week 14 ]