Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
1 participant was randomized after the first dose of study drug was taken; the participant was randomized to placebo, but the actual drug taken was pregabalin. This partcipant was included in the placebo group for all baseline characteristics and efficacy outcome measures; and in the pregabalin group for overall study and adverse events reporting.

Reporting Groups

	Description
Pregabalin	Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
Placebo	Placebo matching study treatment.

Participant Flow:   Overall Study

	Pregabalin	Placebo
STARTED	112	108
Treated	112	107
COMPLETED	93	91
NOT COMPLETED	19	17
Lack of Efficacy	1	2
Withdrawal by Subject	3	3
Protocol Violation	5	3
Adverse Event	8	8
Unspecified	2	0
Randomized, unknown if treated	0	1

Reporting Groups

	Description
Pregabalin	Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
Placebo	Placebo matching study treatment.

Baseline Measures

	Pregabalin	Placebo	Total
Number of Participants   [units: participants]	111	108	219
Age [1] [units: years] Mean ± Standard Deviation	46.1  ± 12.7	45.6  ± 13.8	45.9  ± 13.3
Age, Customized   [units: participants]
Between 18 and 44 years	52	53	105
Between 45 and 64 years	50	45	95
>= 65 years	9	10	19
Gender   [units: participants]
Female	27	16	43
Male	84	92	176

1.  Primary:

Duration Adjusted Average Change (DAAC) of Mean Pain Score   [ Time Frame: Baseline, Week 16 ]

2.  Secondary:

Change From Baseline in Weekly Mean Pain Score   [ Time Frame: Baseline, Week 16 ]

3.  Secondary:

Number of Participants With >=30% Reduction in Weekly Mean Pain Score From Baseline   [ Time Frame: Baseline, Week 16 ]

4.  Secondary:

Number of Participants With Categorical Scores on the Patient Global Impression of Change (PGIC) (Full Scale)   [ Time Frame: Baseline, Week 16 ]

5.  Secondary:

Change From Baseline in Weekly Mean Sleep Interference Score   [ Time Frame: Baseline, Week 16 ]

6.  Secondary:

Change From Baseline in Weekly Mean Pain Score by Week   [ Time Frame: Baseline, Week 1 through16 ]

7.  Secondary:

Number of Participants With >=50% Reduction in Weekly Mean Pain Score From Baseline   [ Time Frame: Baseline, Week 16 ]

8.  Secondary:

Change From Baseline in Modified Brief Pain Inventory Interference Scale (10-Item) (mBPI-10) Total Score   [ Time Frame: Baseline, Week 16 ]

9.  Secondary:

Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP) - Static Mechanical Allodynia   [ Time Frame: Baseline, Week 16 ]

10.  Secondary:

Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP) - Dynamic Mechanical Allodynia   [ Time Frame: Baseline, Week 16 ]

11.  Secondary:

Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Punctata Hyperalgesia   [ Time Frame: Baseline, Week 16 ]

12.  Secondary:

Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Temporal Summation to Tactile Stimuli   [ Time Frame: Baseline, Week 16 ]

13.  Secondary:

Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Cold Allodynia   [ Time Frame: Baseline, Week 16 ]

14.  Secondary:

Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Cold Hyperalgesia Subscales   [ Time Frame: Baseline, Week 16 ]

15.  Secondary:

Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - 12 Items Total Intensity Score   [ Time Frame: Baseline, Week 16 ]

16.  Secondary:

Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Burning Spontaneous Pain   [ Time Frame: Baseline, Week 16 ]

17.  Secondary:

Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Pressing Spontaneous Pain   [ Time Frame: Baseline, Week 16 ]

18.  Secondary:

Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain   [ Time Frame: Baseline, Week 16 ]

19.  Secondary:

Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain   [ Time Frame: Baseline, Week 16 ]

20.  Secondary:

Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysesthesia   [ Time Frame: Baseline, Week 16 ]

21.  Secondary:

Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Individual Item (1, 2, 3, 5, 6, 8, 9, 10, 11, 12) Score   [ Time Frame: Baseline, Week 16 ]

22.  Secondary:

Number of Participants With Improved Duration of Brief Pain Attacks Based on NPSI - Duration (Item 4)   [ Time Frame: Baseline, Week 16 ]

23.  Secondary:

Number of Participants With Improvement in the Number of Attacks Based on NPSI - Number of Attacks (Item 7)   [ Time Frame: Baseline, Week 16 ]

24.  Secondary:

Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS)- 9-Item Overall Sleep Problems Index   [ Time Frame: Baseline, Week 16 ]

25.  Secondary:

Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Disturbance   [ Time Frame: Baseline, Week 16 ]

26.  Secondary:

Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Adequacy   [ Time Frame: Baseline, Week 16 ]

27.  Secondary:

Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Snoring   [ Time Frame: Baseline, Week 16 ]

28.  Secondary:

Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Awaken Short of Breath or With a Headache   [ Time Frame: Baseline, Week 16 ]

29.  Secondary:

Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Quantity   [ Time Frame: Baseline, Week 16 ]

30.  Secondary:

Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Somnolence   [ Time Frame: Baseline, Week 16 ]

31.  Secondary:

Number of Participants Having Optimal Sleep Based on Medical Outcomes Study Sleep Scale (MOS-SS)   [ Time Frame: Baseline, Week 16 ]

32.  Secondary:

Change From Baseline in Hospital and Anxiety Depression Scale (HADS) - Anxiety   [ Time Frame: Baseline, Week 16 ]

33.  Secondary:

Change From Baseline in Hospital and Anxiety Depression Scale (HADS) - Depression   [ Time Frame: Baseline, Week 16 ]

34.  Other Pre-specified:

Change From Baseline in Weekly Mean Sleep Interference Score by Week   [ Time Frame: Baseline, Week 1 through 16 ]