Trial Outcomes & Findings for A Study To Assess The Ability Of A Crossover Study Design To Detect The Efficacy Of Pregabalin In Post-Traumatic Neuropathic Pain Patients (NCT NCT00654940)

Last Updated: 2021-02-09

Results Overview

Daily Pain Rating Scale by treatment and sequence using an 11-point Likert scale: range 0 (no pain) to 10 (worst possible pain) over the past 24 hours. Self-assessment was performed daily on rising from bed (for the final time in the case of interrupted sleep). Average daily pain score: mean of the previous 7 days daily pain scores. Baseline was defined as the mean of the last 7 pre-treatment pain scores for each period. End of treatment was defined as the mean of the last 7 on treatment pain scores for each period.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

25 participants

Primary outcome timeframe

Week 0 to Week 2, Week 4 to Week 6 (Baseline to Week 2 [End of Treatment] for each treatment period)

Results posted on

2021-02-09

Participant Flow

Subjects participated in the study between 05 May 2008 and 10 February 2009.

Subjects meeting entry criteria entered into a 1-week screening period to monitor daily pain scores and activity levels. If pain severity met inclusion criteria subjects could enter the double-blind part of the study and were randomized to 1 of 2 treatment sequence crossovers (pregabalin/placebo or placebo/pregabalin).

Participant milestones

Participant milestones
Measure	Pregabalin First Then Placebo Pregabalin: Day 1: 75 mg in the evening, Days 2 \& 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. Twice daily (BID) dosing on Days 2-14. Placebo: Day 1 in the evening, Days 2-14 BID, Day 15 in the morning.	Placebo First Then Pregabalin Placebo: Day 1 in the evening, Days 2-14 BID, Day 15 in the morning. Pregabalin: Day 1: 75 mg in the evening, Days 2 \& 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. Twice daily (BID) dosing on Days 2-14.
Period 1 STARTED	13	12
Period 1 Received Study Treatment	12	12
Period 1 COMPLETED	12	11
Period 1 NOT COMPLETED	1	1
Washout Period of 2 Weeks STARTED	12	11
Washout Period of 2 Weeks COMPLETED	12	11
Washout Period of 2 Weeks NOT COMPLETED	0	0
Period 2 STARTED	12	11
Period 2 COMPLETED	12	11
Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Pregabalin First Then Placebo Pregabalin: Day 1: 75 mg in the evening, Days 2 \& 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. Twice daily (BID) dosing on Days 2-14. Placebo: Day 1 in the evening, Days 2-14 BID, Day 15 in the morning.	Placebo First Then Pregabalin Placebo: Day 1 in the evening, Days 2-14 BID, Day 15 in the morning. Pregabalin: Day 1: 75 mg in the evening, Days 2 \& 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. Twice daily (BID) dosing on Days 2-14.
Period 1 Adverse Event	0	1
Period 1 Intolerable Pain Level	1	0

Baseline Characteristics

A Study To Assess The Ability Of A Crossover Study Design To Detect The Efficacy Of Pregabalin In Post-Traumatic Neuropathic Pain Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pregabalin Then Placebo n=13 Participants Pregabalin: Day 1: 75 mg in the evening, Days 2 \& 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. BID dosing Days 2-14. Placebo: Day 1 in the evening, Days 2 to 14 BID, Day 15 in the morning.	Placebo Then Pregabalin n=12 Participants Placebo: Day 1 in the evening, Days 2 to 14 BID, Day 15 in the morning. Pregabalin: Day 1: 75 mg in the evening, Days 2 \& 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. BID dosing Days 2-14.	Total n=25 Participants Total of all reporting groups
Age, Customized 18 - 44 years	4 years 0 • n=5 Participants	3 years 0 • n=7 Participants	7 years 0 • n=5 Participants
Age, Customized 45 - 64 years	5 years 16.7 • n=5 Participants	8 years 11.8 • n=7 Participants	13 years n=5 Participants
Age, Customized >=65 years	4 years 0 • n=5 Participants	1 years 0 • n=7 Participants	5 years 0 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 0 to Week 2, Week 4 to Week 6 (Baseline to Week 2 [End of Treatment] for each treatment period)

Population: Full Analysis Set: (FAS): all subjects randomized who received at least one dose of study drug, regardless of whether they had efficacy data. Baseline is Week 0 and Week 4 for Periods 1 and 2, respectively. Treatment Week 2 is End of Treatment (Week 2 and Week 6) for Periods 1 and 2, respectively.

Outcome measures

Outcome measures
Measure	Period 1: Pregabalin n=13 Participants Day 1: 75 mg in the evening, Days 2 \& 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. BID dosing on Days 2-14.	Period 1: Placebo n=12 Participants Day 1 in the evening, Days 2-14 BID, Day 15 in the morning.	Period 2: Placebo n=12 Participants Day 1 in the evening, Days 2-14 BID, Day 15 in the morning.	Period 2: Pregabalin n=11 Participants Day 1: 75 mg in the evening, Days 2 \& 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. BID dosing on Days 2-14.
Change From Baseline to Treatment Week 2 in Daily Pain Rating Scale Baseline	6.03 scores on scale Standard Deviation 1.29	5.24 scores on scale Standard Deviation 2.03	5.96 scores on scale Standard Deviation 0.88	5.31 scores on scale Standard Deviation 1.82
Change From Baseline to Treatment Week 2 in Daily Pain Rating Scale Treatment Week 2	5.40 scores on scale Standard Deviation 1.34	5.08 scores on scale Standard Deviation 2.05	6.11 scores on scale Standard Deviation 1.20	4.38 scores on scale Standard Deviation 2.02
Change From Baseline to Treatment Week 2 in Daily Pain Rating Scale Change from Baseline	-0.63 scores on scale Standard Deviation 1.01	-0.16 scores on scale Standard Deviation 0.97	0.16 scores on scale Standard Deviation 1.07	-0.93 scores on scale Standard Deviation 1.24

SECONDARY outcome

Timeframe: Week 0 to Week 2, Week 4 to Week 6 (Baseline to End of Treatment in Treatment Periods 1 and 2)

Population: FAS. Weeks 0 and 4 are baseline for Periods 1 and 2, respectively. Weeks 2 and 6 are End of Treatment for Periods 1 and 2, respectively.

NPSI at end of treatment: 10-item self-administered questionnaire assessing 5 dimensions of pain (burning superficial spontaneous pain, pressing deep spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dysesthesia). Each item consists of a question about the specific qualities of pain and an 11-point numerical scale range: 0 (absence of pain) to 10 (maximum intensity imaginable), and 2 temporal items related to spontaneous and paroxysmal pain. Maximum total score possible = 100.

Outcome measures

Outcome measures
Measure	Period 1: Pregabalin n=13 Participants Day 1: 75 mg in the evening, Days 2 \& 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. BID dosing on Days 2-14.	Period 1: Placebo n=12 Participants Day 1 in the evening, Days 2-14 BID, Day 15 in the morning.	Period 2: Placebo Day 1 in the evening, Days 2-14 BID, Day 15 in the morning.	Period 2: Pregabalin Day 1: 75 mg in the evening, Days 2 \& 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. BID dosing on Days 2-14.
Neuropathic Pain Symptom Inventory (NPSI) Week 2 (End of Treatment: Treatment Period 1)	5.31 scores on scale Standard Deviation 3.30	4.91 scores on scale Standard Deviation 2.30	—	—
Neuropathic Pain Symptom Inventory (NPSI) Week 4 (Baseline: Treatment Period 2)	4.33 scores on scale Standard Deviation 3.14	5.27 scores on scale Standard Deviation 2.45	—	—
Neuropathic Pain Symptom Inventory (NPSI) Week 6 (End of Treatment: Treatment Period 2)	4.75 scores on scale Standard Deviation 3.39	3.00 scores on scale Standard Deviation 2.24	—	—
Neuropathic Pain Symptom Inventory (NPSI) Week 0 (Baseline: Treatment Period 1)	5.31 scores on scale Standard Deviation 3.50	5.25 scores on scale Standard Deviation 2.38	—	—

SECONDARY outcome

Timeframe: Week 0 to Week 2, Week 4 to Week 6 (Baseline to End of Treatment in Treatment Periods 1 and 2)

Population: FAS; End of Treatment is treatment week 2 (Week 2 and Week 6) for Periods 1 and 2.

Total activity score: Day (8 am to 8 pm) at end of treatment. Accelerometer measured physical activity by monitoring degree and intensity of body motion. Data is reported as activity counts. Subject activity was collected hourly for the variables: peak, average, and total activity. Higher score indicates greater activity (no activity = 0; total possible score was not defined).

Outcome measures

Outcome measures
Measure	Period 1: Pregabalin n=24 Participants Day 1: 75 mg in the evening, Days 2 \& 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. BID dosing on Days 2-14.	Period 1: Placebo n=24 Participants Day 1 in the evening, Days 2-14 BID, Day 15 in the morning.	Period 2: Placebo Day 1 in the evening, Days 2-14 BID, Day 15 in the morning.	Period 2: Pregabalin Day 1: 75 mg in the evening, Days 2 \& 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. BID dosing on Days 2-14.
Subject Activity as Captured by the Actiwatch Score Device: Total Activity Score at End of Treatment	300000 scores on scale Standard Error 12000	270000 scores on scale Standard Error 12000	—	—

Adverse Events

Pregabalin

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \< 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER

Other adverse events
Measure	Pregabalin n=24 participants at risk Day 1: 75 mg in the evening, Days 2 \& 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. BID dosing Days 2-14.	Placebo n=24 participants at risk Day 1 in the evening, Days 2 to 14 BID, Day 15 in the morning.
Ear and labyrinth disorders Vertigo	0.00% 0/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.	4.2% 1/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.
Eye disorders Eye disorder	4.2% 1/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.	0.00% 0/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.
Eye disorders Vision blurred	4.2% 1/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.	4.2% 1/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.
Gastrointestinal disorders Abdominal pain	0.00% 0/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.	4.2% 1/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.
Gastrointestinal disorders Dry mouth	8.3% 2/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.	4.2% 1/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.
Gastrointestinal disorders Hypoaesthesia oral	4.2% 1/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.	0.00% 0/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.
Gastrointestinal disorders Nausea	16.7% 4/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.	12.5% 3/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.
General disorders Fatigue	8.3% 2/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.	4.2% 1/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.
General disorders Influenza like illness	4.2% 1/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.	0.00% 0/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.
General disorders Oedema peripheral	4.2% 1/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.	4.2% 1/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.
General disorders Therapeutic response unexpected	4.2% 1/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.	0.00% 0/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.
Infections and infestations Nasopharyngitis	4.2% 1/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.	4.2% 1/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.
Infections and infestations Upper respiratory tract infection	4.2% 1/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.	4.2% 1/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.
Injury, poisoning and procedural complications Arthropod bite	4.2% 1/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.	4.2% 1/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.
Metabolism and nutrition disorders Increased appetite	4.2% 1/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.	0.00% 0/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.	4.2% 1/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.	4.2% 1/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.
Nervous system disorders Disturbance in attention	4.2% 1/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.	0.00% 0/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.
Nervous system disorders Dizziness	25.0% 6/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.	4.2% 1/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.
Nervous system disorders Dysgeusia	4.2% 1/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.	4.2% 1/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.
Nervous system disorders Headache	12.5% 3/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.	0.00% 0/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.
Nervous system disorders Somnolence	12.5% 3/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.	0.00% 0/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.
Psychiatric disorders Insomnia	4.2% 1/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.	0.00% 0/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.
Psychiatric disorders Thinking abnormal	4.2% 1/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.	4.2% 1/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.
Respiratory, thoracic and mediastinal disorders Cough	4.2% 1/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.	0.00% 0/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.
Respiratory, thoracic and mediastinal disorders Diaphragmalgia	0.00% 0/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.	4.2% 1/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.
Respiratory, thoracic and mediastinal disorders Throat irritation	4.2% 1/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.	0.00% 0/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.
Skin and subcutaneous tissue disorders Hyperhidrosis	4.2% 1/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.	4.2% 1/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.
Skin and subcutaneous tissue disorders Pruritus	4.2% 1/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.	4.2% 1/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.
Vascular disorders Hot flush	4.2% 1/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.	0.00% 0/24 Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.