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Safety and Efficacy Study of Fx-1006A in Patients With Familial Amyloidosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00409175
Recruitment Status : Completed
First Posted : December 8, 2006
Results First Posted : December 17, 2012
Last Update Posted : December 17, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Familial Amyloid Polyneuropathy
Interventions Drug: Fx-1006A
Drug: Placebo
Enrollment 128
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tafamidis Placebo
Hide Arm/Group Description Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months. Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
Period Title: Overall Study
Started 65 63
Completed 47 44
Not Completed 18 19
Reason Not Completed
Adverse Event             4             3
Withdrawal by Subject             1             2
Negative genotype             0             1
Liver transplantation             13             13
Arm/Group Title Tafamidis Placebo Total
Hide Arm/Group Description Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months. Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months. Total of all reporting groups
Overall Number of Baseline Participants 64 61 125
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 64 participants 61 participants 125 participants
Less than or equal to 65 years 59 58 117
Greater than 65 years 5 3 8
[1]
Measure Description: Out of a total of 128 participants, baseline characteristic (Age) was available for only 125 participants who were included in intent-to-treat (ITT) population.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 61 participants 125 participants
Female
32
  50.0%
35
  57.4%
67
  53.6%
Male
32
  50.0%
26
  42.6%
58
  46.4%
[1]
Measure Description: Out of a total of 128 participants, baseline characteristic (Gender) was available for only 125 participants who were included in ITT population.
1.Primary Outcome
Title Percentage of Participants With Response to Treatment as Measured by Neuropathy Impairment Score - Lower Limb (NIS-LL) at Month 18
Hide Description Response to treatment was indicated by either improvement (decrease from baseline) or stabilization (change from baseline of 0 to less than[<] 2) in NIS-LL score, based on mean of 2 scores in 1 week period. NIS-LL: assessed muscle weakness, reflexes, sensation. Each item scored separately for left, right limbs. Components of muscle weakness scored on 0(normal) to 4(paralysis) scale, higher score=greater weakness. Components of reflexes, sensation scored 0=normal, 1=decreased, or 2=absent. Total NIS-LL score range 0-88, higher score=greater impairment.
Time Frame Month 18
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Hide Analysis Population Description
ITTset:randomized participants received atleast(>=)1 dose of study drug, had >=1 post-baseline efficacy assessment for NIS-LL,Norfolk Quality of Life-Diabetic Neuropathy(QOL-DN) or discontinued study due to death/liver transplant(LT).Last-observation-carried-forward(LOCF) used;participant who discontinued due to death/LT was set non-responder.
Arm/Group Title Tafamidis Placebo
Hide Arm/Group Description:
Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
Overall Number of Participants Analyzed 64 61
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
45.3
(33.1 to 57.5)
29.5
(18.1 to 41.0)
2.Primary Outcome
Title Change From Baseline in Norfolk Quality of Life- Diabetic Neuropathy (QOL-DN) Total Quality of Life (TQOL) Score at Month 18
Hide Description Norfolk QOL-DN: 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy; Item 1 to 7: related to symptoms and presence of symptom was assessed as 1 and absence was assessed as 0. Item 8-35: related to activities of daily living and scored on a 5-point Likert scale, where 0= no problem and 4= severe problem (except item 32, where -2= much better, 0=about the same, 2=much worse). TQOL= sum of all the items, total possible score range= -2 to 138, where higher score=worse quality of life.
Time Frame Baseline, Month 18
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment for NIS-LL and Norfolk QOL-DN or discontinued study due to death or LT. LOCF method was used.
Arm/Group Title Tafamidis Placebo
Hide Arm/Group Description:
Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
Overall Number of Participants Analyzed 64 61
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 27.3  (24.2) 30.8  (26.7)
Change at Month 18 2.4  (14.6) 6.9  (22.9)
3.Secondary Outcome
Title Change From Baseline in Neuropathy Impairment Score- Lower Limb (NIS-LL) Score at Month 6, 12 and 18
Hide Description NIS-LL: assessed muscle weakness, reflexes and sensation; scored separately for left and right limbs. Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) are scored on 0(normal) to 4(paralysis) scale, higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) were scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS-LL score range 0-88, higher score=greater impairment.
Time Frame Baseline, Month 6, 12, 18
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment for NIS-LL and Norfolk QOL-DN or discontinued study due to death/LT. ‘n’ = those participants who were evaluable for this measure at given time point for each group respectively.
Arm/Group Title Tafamidis Placebo
Hide Arm/Group Description:
Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
Overall Number of Participants Analyzed 64 61
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=64, 61) 8.359  (11.399) 11.445  (13.544)
Change at Month 6 (n=60, 57) 1.260  (3.007) 2.075  (6.407)
Change at Month 12 (n=49, 50) 1.005  (3.964) 4.835  (7.697)
Change at Month 18 (n=48, 47) 2.193  (4.372) 5.402  (8.661)
4.Secondary Outcome
Title Percentage of Participants With Response to Treatment as Measured by Neuropathy Impairment Score - Lower Limb (NIS-LL) at Month 6 and 12
Hide Description Response to treatment was indicated by either improvement (decrease from baseline) or stabilization (change from baseline of 0 to <2) in NIS-LL score, based on mean of 2 scores in 1 week period. NIS-LL: assessed muscle weakness, reflexes, sensation. Each item scored separately for left, right limbs. Components of muscle weakness scored on 0 (normal) to 4 (paralysis) scale, higher score=greater weakness. Components of reflexes, sensation scored 0=normal, 1=decreased, or 2=absent. Total NIS-LL score range 0-88, higher score=greater impairment.
Time Frame Month 6, 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment for NIS-LL and Norfolk QOL-DN or discontinued study due to death/LT. LOCF method was used; participant who discontinued due to death/LT was set non-responder.
Arm/Group Title Tafamidis Placebo
Hide Arm/Group Description:
Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
Overall Number of Participants Analyzed 64 61
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Month 6
60.9
(49.0 to 72.9)
54.1
(41.6 to 66.6)
Month 12
54.7
(42.5 to 66.9)
32.8
(21.0 to 44.6)
5.Secondary Outcome
Title Change From Baseline in Norfolk Quality of Life - Diabetic Neuropathy (QOL-DN) Total Quality of Life (TQOL) Score at Month 6 and 12
Hide Description Norfolk QOL-DN: 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy; Item 1 to 7: related to symptoms and presence of symptom was assessed as 1 and absence was assessed as 0. Item 8-35: related to activities of daily living and scored on a 5-point Likert scale, where 0= no problem and 4= severe problem (except item 32, where -2= much better, 0=about the same, 2=much worse). TQOL= sum of all the items, total possible score range= -2 to 138, where higher score=worse quality of life.
Time Frame Baseline, Month 6, 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment for NIS-LL and Norfolk QOL-DN or discontinued study due to death/LT. ‘n’ = those participants who were evaluable for this measure at given time point for each group respectively.
Arm/Group Title Tafamidis Placebo
Hide Arm/Group Description:
Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
Overall Number of Participants Analyzed 64 61
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=64, 61) 27.3  (24.2) 30.8  (26.7)
Change at Month 6 (n=60, 57) 1.2  (15.6) 0.2  (15.1)
Change at Month 12 (n=49, 50) 1.1  (14.7) 4.6  (19.0)
6.Secondary Outcome
Title Change From Baseline in Norfolk Quality of Life - Diabetic Neuropathy (QOL-DN) Domain Scores at Month 6, 12 and 18
Hide Description Norfolk QOL-DN:35-item participant-rated questionnaire to assess impact of DN on QOL; Item 1-7:scored as 1=symptom present, 0=symptom absent. Item 8-35: scored on 5-point Likert scale: 0=no problem, 4=severe problem (except item 32: -2=much better, 0=about same, 2=much worse). Norfolk QOL-DN summarized in 5 domains(score range):physical functioning/large fiber neuropathy(-2 to 58), activities of daily living(ADLs) (0 to 20), symptoms(0 to 32), small fiber neuropathy(0 to 16), autonomic neuropathy(0 to 12); higher score=greater impairment, for each. Total score=-2 to138(higher score=worse QOL).
Time Frame Baseline, Month 6, 12, 18
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment for NIS-LL and Norfolk QOL-DN or discontinued study due to death or LT. ‘n’ = those participants who were evaluable for this measure at given time points for each group respectively.
Arm/Group Title Tafamidis Placebo
Hide Arm/Group Description:
Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
Overall Number of Participants Analyzed 64 61
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline: physical functioning(n=64,61) 14.3  (13.8) 16.6  (14.7)
Baseline: ADLs(n=64,61) 1.3  (2.9) 1.6  (3.8)
Baseline: symptoms(n=64,61) 7.2  (5.5) 7.6  (6.1)
Baseline: small fiber neuropathy(n=64,61) 2.7  (3.6) 3.1  (4.0)
Baseline: autonomic neuropathy(n=64,61) 1.9  (2.4) 2.0  (2.6)
Change at Month 6: physical functioning(n=60,57) -0.6  (8.0) -0.9  (9.8)
Change at Month 6: ADLs(n=60,57) 0.4  (1.9) 0.3  (1.7)
Change at Month 6: symptoms(n=60,56) 0.8  (5.5) 0.2  (4.4)
Change at Month 6: small fiber neuropathy(n=60,57) 0.4  (2.2) 0.5  (2.5)
Change at Month 6: autonomic neuropathy(n=60,57) 0.2  (1.8) 0.0  (1.7)
Change at Month 12: physical functioning(n=49,50) -0.9  (7.4) 0.6  (10.7)
Change at Month 12: ADLs(n=49,50) 1.0  (2.4) 0.7  (3.0)
Change at Month 12: symptoms(n=49,49) 0.4  (5.0) 1.4  (4.5)
Change at Month 12:small fiber neuropathy(n=49,50) 0.7  (2.8) 1.5  (3.1)
Change at Month 12: autonomic neuropathy(n=49,50) -0.1  (1.8) 0.4  (2.8)
Change at Month 18: physical functioning(n=48,47) -0.1  (8.5) 3.0  (14.0)
Change at Month 18: ADLs(n=48,47) 1.2  (2.4) 1.2  (4.2)
Change at Month 18: symptoms(n=48,47) -0.1  (4.9) 1.2  (5.4)
Change at Month 18:small fiber neuropathy(n=48,47) 0.8  (2.6) 1.4  (3.6)
Change at Month 18: autonomic neuropathy(n=48,47) 0.2  (1.9) 0.4  (2.8)
7.Secondary Outcome
Title Change From Baseline in Summated 7 Score for Large Nerve Fiber Function at Month 6, 12 and 18
Hide Description Summated 7 score: composite score included five Nerve Conduction Studies (NCS) attributes (peroneal nerve distal motor latency, peroneal nerve compound muscle action potential, peroneal nerve motor conduction velocity, tibial nerve distal motor latency, and sural nerve sensory nerve action potential amplitude) along with Vibration Detection Threshold (VDT) obtained in great toes, and Heart Rate Response to Deep Breathing (HRDB) value. Score was determined through reference to normal values for age, sex and height. Total score range= -26 to 26, where higher score=worse nerve function.
Time Frame Baseline, Month 6, 12, 18
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment for NIS-LL and Norfolk QOL-DN or discontinued study due to death/LT. ‘n’ = those participants who were evaluable for this measure at given time points for each group respectively.
Arm/Group Title Tafamidis Placebo
Hide Arm/Group Description:
Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
Overall Number of Participants Analyzed 64 61
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=64, 61) 7.787  (9.063) 8.718  (8.533)
Change at Month 6 (n=60, 57) 0.581  (3.542) 1.934  (3.846)
Change at Month 12 (n=48, 50) 0.833  (3.963) 2.959  (3.879)
Change at Month 18 (n=48, 46) 1.159  (3.853) 3.333  (4.997)
8.Secondary Outcome
Title Change From Baseline in Summated 3 Score for Small Nerve Fiber Function at Month 6, 12 and 18
Hide Description Summated 3 Nerve Tests Small Fiber Normal Deviates Score (NTSFnds) included cooling threshold for the lower limbs, heat pain threshold for the lower limbs and HRDB. Total score range= -11.2 to 11.2, where higher score=worse nerve function.
Time Frame Baseline, Month 6, 12, 18
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment for NIS-LL and Norfolk QOL-DN or discontinued study due to death/LT. ‘n’ = those participants who were evaluable for this measure at given time points for each group respectively.
Arm/Group Title Tafamidis Placebo
Hide Arm/Group Description:
Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
Overall Number of Participants Analyzed 64 61
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=64, 61) 5.514  (4.535) 5.624  (4.085)
Change at Month 6 (n=60, 57) 0.240  (1.679) 0.716  (2.202)
Change at Month 12 (n=48, 50) 0.375  (2.048) 1.250  (2.010)
Change at Month 18 (n=48, 46) 0.290  (2.130) 1.489  (2.519)
9.Secondary Outcome
Title Change From Baseline in Modified Body Mass Index (mBMI) at Month 6, 12 and 18
Hide Description BMI was calculated by weight divided by height squared. mBMI was calculated by multiplying BMI by serum albumin levels to compensate for edema formation associated with malnutrition. A progressive decline in mBMI indicated worsening of disease severity.
Time Frame Baseline, Month 6, 12, 18
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment for NIS-LL and Norfolk QOL-DN or discontinued study due to death/LT. ‘n’ = those participants who were evaluable for this measure at given time points for each group respectively.
Arm/Group Title Tafamidis Placebo
Hide Arm/Group Description:
Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
Overall Number of Participants Analyzed 64 61
Mean (Standard Deviation)
Unit of Measure: (kilogram/square meter)*(gram/liter)
Baseline (n=64, 61) 1004.6  (165.2) 1011.5  (212.9)
Change at Month 6 (n=60, 56) 17.1  (68.4) -29.8  (69.7)
Change at Month 12 (n=49, 50) 19.4  (71.8) -30.8  (74.9)
Change at Month 18 (n=49, 46) 37.9  (73.7) -32.7  (88.6)
10.Secondary Outcome
Title Percentage of Participants With Stabilized Transthyretin (TTR) Tetramer
Hide Description TTR tetramer was assessed using a validated immunoturbidimetric assay. The Fraction of Initial (FOI) is the ratio of the measured TTR tetramer concentration after denaturation to the measured TTR tetramer concentration before denaturation. TTR tetramer stabilization is based on the difference between the on-treatment FOI and the baseline FOI expressed as a percentage of the baseline FOI.
Time Frame Week 8, Month 6, 12, 18
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ = those participants who were evaluable for this measure at given time points for each group respectively.
Arm/Group Title Tafamidis Placebo
Hide Arm/Group Description:
Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
Overall Number of Participants Analyzed 63 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 8 (n=63, 60)
98.4
(95.3 to 100.0)
6.7
(0.4 to 13.0)
Month 6 (n= 59, 58)
100.0
(100.0 to 100.0)
5.2
(0.0 to 10.9)
Month 12 (n=48, 50)
97.9
(93.9 to 100.0)
2.0
(0.0 to 5.9)
Month 18 (n=48, 44)
97.9
(93.9 to 100.0)
0.0
(0.0 to 0.0)
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Tafamidis Placebo
Hide Arm/Group Description Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months. Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
All-Cause Mortality
Tafamidis Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tafamidis Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   6/65 (9.23%)   5/63 (7.94%) 
Blood and lymphatic system disorders     
Anaemia * 1  0/65 (0.00%)  1/63 (1.59%) 
Cardiac disorders     
Conduction disorder * 1  1/65 (1.54%)  0/63 (0.00%) 
Cardiac amyloidosis * 1  0/65 (0.00%)  1/63 (1.59%) 
Gastrointestinal disorders     
Nausea * 1  0/65 (0.00%)  1/63 (1.59%) 
Vomiting * 1  0/65 (0.00%)  1/63 (1.59%) 
General disorders     
Catheter site phlebitis * 1  0/65 (0.00%)  1/63 (1.59%) 
Oedema peripheral * 1  0/65 (0.00%)  1/63 (1.59%) 
Infections and infestations     
Urinary tract infection * 1  2/65 (3.08%)  0/63 (0.00%) 
Localised infection * 1  1/65 (1.54%)  0/63 (0.00%) 
Pneumonia * 1  1/65 (1.54%)  0/63 (0.00%) 
Viral infection * 1  1/65 (1.54%)  0/63 (0.00%) 
Cellulitis * 1  0/65 (0.00%)  1/63 (1.59%) 
Lymphangitis * 1  0/65 (0.00%)  1/63 (1.59%) 
Staphylococcal infection * 1  0/65 (0.00%)  1/63 (1.59%) 
Injury, poisoning and procedural complications     
Burns third degree * 1  0/65 (0.00%)  1/63 (1.59%) 
Nervous system disorders     
Syncope * 1  0/65 (0.00%)  1/63 (1.59%) 
Respiratory, thoracic and mediastinal disorders     
Pneumothorax * 1  0/65 (0.00%)  1/63 (1.59%) 
Skin and subcutaneous tissue disorders     
Urticaria * 1  1/65 (1.54%)  0/63 (0.00%) 
Skin ulcer * 1  0/65 (0.00%)  1/63 (1.59%) 
Vascular disorders     
Hypertensive emergency * 1  0/65 (0.00%)  1/63 (1.59%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tafamidis Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   57/65 (87.69%)   56/63 (88.89%) 
Blood and lymphatic system disorders     
Anaemia * 1  0/65 (0.00%)  4/63 (6.35%) 
Cardiac disorders     
Atrioventricular block first degree * 1  2/65 (3.08%)  6/63 (9.52%) 
Ear and labyrinth disorders     
Vertigo * 1  3/65 (4.62%)  4/63 (6.35%) 
Eye disorders     
Lacrimation decreased * 1  6/65 (9.23%)  7/63 (11.11%) 
Punctate keratitis * 1  5/65 (7.69%)  3/63 (4.76%) 
Gastrointestinal disorders     
Diarrhoea * 1  17/65 (26.15%)  11/63 (17.46%) 
Nausea * 1  8/65 (12.31%)  8/63 (12.70%) 
Vomiting * 1  7/65 (10.77%)  7/63 (11.11%) 
Constipation * 1  4/65 (6.15%)  7/63 (11.11%) 
Abdominal pain upper * 1  8/65 (12.31%)  2/63 (3.17%) 
Abdominal pain * 1  3/65 (4.62%)  5/63 (7.94%) 
General disorders     
Oedema peripheral * 1  4/65 (6.15%)  8/63 (12.70%) 
Fatigue * 1  0/65 (0.00%)  6/63 (9.52%) 
Infections and infestations     
Urinary tract infection * 1  14/65 (21.54%)  8/63 (12.70%) 
Influenza * 1  10/65 (15.38%)  9/63 (14.29%) 
Nasopharyngitis * 1  9/65 (13.85%)  8/63 (12.70%) 
Pharyngitis * 1  4/65 (6.15%)  5/63 (7.94%) 
Upper respiratory tract infection * 1  4/65 (6.15%)  3/63 (4.76%) 
Vaginal infection * 1  4/65 (6.15%)  1/63 (1.59%) 
Injury, poisoning and procedural complications     
Thermal burn * 1  4/65 (6.15%)  5/63 (7.94%) 
Investigations     
Weight decreased * 1  3/65 (4.62%)  5/63 (7.94%) 
Musculoskeletal and connective tissue disorders     
Pain in extremity * 1  11/65 (16.92%)  6/63 (9.52%) 
Back pain * 1  5/65 (7.69%)  4/63 (6.35%) 
Muscle spasms * 1  2/65 (3.08%)  7/63 (11.11%) 
Myalgia * 1  5/65 (7.69%)  2/63 (3.17%) 
Nervous system disorders     
Headache * 1  10/65 (15.38%)  12/63 (19.05%) 
Neuralgia * 1  2/65 (3.08%)  12/63 (19.05%) 
Paraesthesia * 1  3/65 (4.62%)  10/63 (15.87%) 
Dizziness * 1  2/65 (3.08%)  4/63 (6.35%) 
Hypoaesthesia * 1  1/65 (1.54%)  4/63 (6.35%) 
Psychiatric disorders     
Anxiety * 1  4/65 (6.15%)  3/63 (4.76%) 
Depression * 1  4/65 (6.15%)  3/63 (4.76%) 
Reproductive system and breast disorders     
Erectile dysfunction * 1  4/65 (6.15%)  4/63 (6.35%) 
Respiratory, thoracic and mediastinal disorders     
Pharyngolaryngeal pain * 1  2/65 (3.08%)  7/63 (11.11%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
Instead of the intended endpoint 'heat pain and cooling threshold', results of 'summated 3 score for small nerve fiber function' were reported.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00409175     History of Changes
Other Study ID Numbers: FX-005
B3461020
First Submitted: December 6, 2006
First Posted: December 8, 2006
Results First Submitted: November 16, 2012
Results First Posted: December 17, 2012
Last Update Posted: December 17, 2012