Trial Outcomes & Findings for Pregabalin Treatment Of Peripheral Neuropathic Pain Associated With Diabetic Peripheral NeP (DPN), Postherpetic Neuralgia (PHN), HIV-related NeP (HIV), and Chemotherapy Induced NeP (NCT NCT00407511)

NCT ID: NCT00407511

Last Updated: 2021-02-09

Results Overview

11 point Likert scale: range 0 to 10 (no pain to worst possible pain) over past 24 hours. Baseline score = mean score of preceding 7 days (including Visit 2). Final end of treatment (EOT) pain score = mean pain score from last 7 post-Baseline days preceding Visit 8 (Week 12) or last 7 days on study drug for those who did not complete the study. Change = mean at EOT minus mean at Baseline.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 121 participants
• Primary outcome timeframe: Baseline, End of Treatment
• Results posted on: 2021-02-09

Participant Flow

Subjects were recruited at 13 medical centers in Latin America and participated between January 2007 and July 2008.

160 subjects were screened and evaluated for inclusion/exclusion criteria; 121 were assigned to open-label treatment.

Participant milestones

Measure	Pregabalin Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
Overall Study STARTED	121
Overall Study COMPLETED	99
Overall Study NOT COMPLETED	22

Reasons for withdrawal

Measure	Pregabalin Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
Overall Study Adverse Event	9
Overall Study Lost to Follow-up	4
Overall Study Other	5
Overall Study Withdrawal by Subject	4

Baseline Characteristics

Pregabalin Treatment Of Peripheral Neuropathic Pain Associated With Diabetic Peripheral NeP (DPN), Postherpetic Neuralgia (PHN), HIV-related NeP (HIV), and Chemotherapy Induced NeP

Baseline characteristics by cohort

Measure	Pregabalin n=121 Participants Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
Age, Customized Between 18 to 44 years	15 participants n=5 Participants
Age, Customized Between 45 to 64 years	76 participants n=5 Participants
Age, Customized >= 65 years	30 participants n=5 Participants
Sex: Female, Male Female	83 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, End of Treatment

Population: Full Analysis Set (FAS): patients who took at least one dose of study medication, had a baseline value, and had at least one post-baseline measurement; Last Observation Carried Forward (LOCF).

11 point Likert scale: range 0 to 10 (no pain to worst possible pain) over past 24 hours. Baseline score = mean score of preceding 7 days (including Visit 2). Final end of treatment (EOT) pain score = mean pain score from last 7 post-Baseline days preceding Visit 8 (Week 12) or last 7 days on study drug for those who did not complete the study. Change = mean at EOT minus mean at Baseline.

Outcome measures

Measure

Pregabalin n=120 Participants Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.

Change From Baseline to End of Treatment (EOT) in Weekly Mean Pain Score on the Daily Pain Rating Scale (DPRS)

-3.8 scores on scale Standard Deviation 2.5

SECONDARY outcome

Timeframe: Week 4, Week 8, Week 12

Population: Full Analysis Set (FAS).

11 point Likert scale; range: 0 to 10 (no pain to worst possible pain) over past 24 hours. Baseline score = mean score of preceding 7 days (including Visit 2). Weekly pain score = mean pain score from last 7 post-Baseline days preceding observation visit or last 7 days on study drug for early termination. Change = mean at observation minus mean at Baseline.

Outcome measures

Measure	Pregabalin n=120 Participants Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
Change From Baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS) Week 4 (n=110)	-3.2 scores on scale Standard Deviation 1.9
Change From Baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS) Week 8 (n=100)	-3.9 scores on scale Standard Deviation 2.3
Change From Baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS) Week 12 (n=96)	-4.2 scores on scale Standard Deviation 2.4

SECONDARY outcome

Timeframe: Baseline, Week 8, Week 12, EOT/LOCF

Population: Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment.

Self-administered questionnaire: change from Baseline in mean pain severity index over past 24 hours; 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst pain possible). Pain severity index is the mean of item scores 2, 3, and 4 (pain right now, worst pain, and average pain level). Change = mean score at observation minus mean score at Baseline.

Outcome measures

Measure	Pregabalin n=120 Participants Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
Change From Baseline (BL) in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores Week 8 (n=102)	-4.2 scores on scale Standard Deviation 2.6
Change From Baseline (BL) in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores Week 12 (n=98)	-4.7 scores on scale Standard Deviation 2.6
Change From Baseline (BL) in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores EOT/LOCF (n=102)	-4.6 scores on scale Standard Deviation 2.6

SECONDARY outcome

Timeframe: Baseline, Week 8, Week 12, End of Treatment/Last Observation Carried Forward (EOT/LOCF)

Population: Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment.

Self-administered questionnaire: change from Baseline in mean pain interference with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. 11-point scale from 0 (does not interfere) to 10 (completely interferes). Change = observation mean minus Baseline mean.

Outcome measures

Measure	Pregabalin n=120 Participants Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
Change From Baseline in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores Week 8 (n=102)	-3.8 scores on scale Standard Deviation 2.7
Change From Baseline in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores Week 12 (n=98)	-4.2 scores on scale Standard Deviation 2.6
Change From Baseline in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores EOT/LOCF (n=102)	-4.0 scores on scale Standard Deviation 2.6

SECONDARY outcome

Timeframe: Baseline, Week 8, Week 12, EOT/LOCF

Population: Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment. Subjects were only included in the Week 8 analysis if their visit fell between Days 49 and 63, and were only included in the Week 12 analysis if their visit was after Day 78.

Impact of current pain medication response scale: 0 (worst possible response) to 100 (best possible response). Score=[(5-mean of non-missing items)*100]/4.

Outcome measures

Measure	Pregabalin n=105 Participants Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication Baseline (n=78)	62.34 scores on scale Standard Deviation 29.99
Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication Week 8 (n=100)	90.38 scores on scale Standard Deviation 16.17
Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication Week 12 (n=97)	91.66 scores on scale Standard Deviation 13.83
Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication EOT/LOCF (n=105)	91.40 scores on scale Standard Deviation 14.95

SECONDARY outcome

Timeframe: Baseline, Week 8, Week 12, EOT/LOCF

Population: Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment. Subjects were only included in the Week 8 analysis if their visit fell between Days 49 and 63, and were only included in the Week 12 analysis if their visit was after Day 78.

Satisfaction with current pain medication response scale: 0 (worst possible response) to 100 (best possible response). Score=[(5-mean of non-missing items)*100]/4.

Outcome measures

Measure	Pregabalin n=105 Participants Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication Baseline (n=78)	52.56 scores on scale Standard Deviation 24.68
Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication Week 8 (n=100)	85.92 scores on scale Standard Deviation 16.96
Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication Week 12 (n=97)	88.56 scores on scale Standard Deviation 13.87
Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication EOT/LOCF (n=105)	88.08 scores on scale Standard Deviation 14.72

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, EOT/LOCF

Population: Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment.

100 mm line (Visual Analog Scale) marked by subject; Intensity of pain range (over past week): 0 = no pain to 100 = worst possible pain. Change = observation mean minus Baseline mean.

Outcome measures

Measure	Pregabalin n=120 Participants Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) Week 1 (n = 120)	-18.8 scores on scale Standard Deviation 21.9
Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) Week 2 (n = 116)	-28.5 scores on scale Standard Deviation 24.1
Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) Week 3 (n = 116)	-34.9 scores on scale Standard Deviation 25.8
Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) Week 4 (n = 109)	-41.0 scores on scale Standard Deviation 24.6
Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) Week 8 (n = 102)	-46.6 scores on scale Standard Deviation 26.2
Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) Week 12 (n = 98)	-49.0 scores on scale Standard Deviation 26.6
Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) EOT/LOCF (n = 120)	-45.9 scores on scale Standard Deviation 28.8

SECONDARY outcome

Timeframe: Baseline, Week 8, Week 12, EOT/LOCF

Population: Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment.

100-mm line (Visual Analog Scale) marked by the subject to measure their degree of anxiety over past 24 hours. Range: 0 = not at all anxious to 100 = extremely anxious. Change = mean score at observation minus mean score at Baseline.

Outcome measures

Measure	Pregabalin n=118 Participants Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
Change From Baseline in Global Anxiety Visual Analogue Scale (GA-VAS) Week 8 (n=99)	-39.2 scores on scale Standard Deviation 29.6
Change From Baseline in Global Anxiety Visual Analogue Scale (GA-VAS) Week 12 (n=97)	-41.4 scores on scale Standard Deviation 32.9
Change From Baseline in Global Anxiety Visual Analogue Scale (GA-VAS) EOT/LOCF (n=101)	-40.5 scores on scale Standard Deviation 33.1

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, EOT/LOCF

Population: Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment.

Daily sleep interference measured on an 11-point Likert scale. Range: 0 (pain did not interfere with sleep) to 10 (pain completely interfered with sleep). Change = mean at observation minus mean at Baseline. Evaluations recorded in patient's daily sleep diaries.

Outcome measures

Measure	Pregabalin n=120 Participants Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
Change From Baseline in Mean Daily Sleep Interference Score (DSIS) Week 1 (n=120)	-1.0 scores on scale Standard Deviation 1.5
Change From Baseline in Mean Daily Sleep Interference Score (DSIS) Week 2 (n=118)	-1.8 scores on scale Standard Deviation 2.0
Change From Baseline in Mean Daily Sleep Interference Score (DSIS) Week 3 (n=114)	-2.5 scores on scale Standard Deviation 2.2
Change From Baseline in Mean Daily Sleep Interference Score (DSIS) Week 4 (n=110)	-2.8 scores on scale Standard Deviation 2.3
Change From Baseline in Mean Daily Sleep Interference Score (DSIS) Week 5 (n=104	-3.0 scores on scale Standard Deviation 2.3
Change From Baseline in Mean Daily Sleep Interference Score (DSIS) Week 6 (n=103)	-3.1 scores on scale Standard Deviation 2.5
Change From Baseline in Mean Daily Sleep Interference Score (DSIS) Week 7 (n=100)	-3.3 scores on scale Standard Deviation 2.5
Change From Baseline in Mean Daily Sleep Interference Score (DSIS) Week 8 (n=100)	-3.4 scores on scale Standard Deviation 2.5
Change From Baseline in Mean Daily Sleep Interference Score (DSIS) Week 9 (n=97)	-3.5 scores on scale Standard Deviation 2.6
Change From Baseline in Mean Daily Sleep Interference Score (DSIS) Week 10 (n=99)	-3.5 scores on scale Standard Deviation 2.7
Change From Baseline in Mean Daily Sleep Interference Score (DSIS) Week 11 (n=98)	-3.5 scores on scale Standard Deviation 2.6
Change From Baseline in Mean Daily Sleep Interference Score (DSIS) Week 12 (n=96)	-3.4 scores on scale Standard Deviation 2.7
Change From Baseline in Mean Daily Sleep Interference Score (DSIS) EOT/LOCF (n=120)	-3.1 scores on scale Standard Deviation 2.7

SECONDARY outcome

Timeframe: End of Treatment/ Last Observation Carried Forward (Week 12 or last post-baseline assessment)

Population: Full Analysis Set (FAS)

7-point participant rating scale for change observed in their overall status since beginning of study medication. Range: 1 (very much improved) to 7 (very much worse)

Outcome measures

Measure	Pregabalin n=103 Participants Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
Patient Global Impression of Change (PGIC) Very much improved	37 participants
Patient Global Impression of Change (PGIC) Much improved	53 participants
Patient Global Impression of Change (PGIC) Minimally improved	12 participants
Patient Global Impression of Change (PGIC) No change	1 participants
Patient Global Impression of Change (PGIC) Minimally worse	0 participants
Patient Global Impression of Change (PGIC) Much worse	0 participants
Patient Global Impression of Change (PGIC) Very much worse	0 participants

SECONDARY outcome

Timeframe: End of Treatment/ Last Observation Carried Forward (Week 12 or last post-baseline assessment)

Population: Full Analysis Set (FAS)

7-point investigator rating scale of change in participant's status since beginning study medication. Range: 1 (very much improved) to 7 (very much worse).

Outcome measures

Measure	Pregabalin n=103 Participants Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
Clinical Global Impression of Change (CGIC) Very much improved	41 participants
Clinical Global Impression of Change (CGIC) Much improved	55 participants
Clinical Global Impression of Change (CGIC) Minimally improved	5 participants
Clinical Global Impression of Change (CGIC) No change	2 participants
Clinical Global Impression of Change (CGIC) Minimally worse	0 participants
Clinical Global Impression of Change (CGIC) Much Worse	0 participants
Clinical Global Impression of Change (CGIC) Very much worse	0 participants

Adverse Events

Pregabalin

Serious events: 4 serious events

Other events: 69 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pregabalin Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
Cardiac disorders Cardiac failure	0.83% 1/121
Cardiac disorders Pericarditis	0.83% 1/121
Eye disorders Vitreous haemorrhage	0.83% 1/121
General disorders Generalized oedema	0.83% 1/121
Musculoskeletal and connective tissue disorders Neuropathic arthropathy	0.83% 1/121
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.83% 1/121
Nervous system disorders Headache	0.83% 1/121

Other adverse events

Measure	Pregabalin Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
Gastrointestinal disorders Dry mouth	6.6% 8/121
Gastrointestinal disorders Nausea	5.0% 6/121
General disorders Oedema	5.8% 7/121
General disorders Oedema peripheral	11.6% 14/121
Investigations Weight increased	12.4% 15/121
Metabolism and nutrition disorders Increased appetite	5.8% 7/121
Nervous system disorders Dizziness	20.7% 25/121
Nervous system disorders Headache	6.6% 8/121
Nervous system disorders Somnolence	31.4% 38/121

Additional Information

Pfizer Clinical Trials.gov Call Center

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Phone: 1-800-718-1021

Email: ClinicalTrials.govCallCenter@pfizer.com

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