Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 16 of 88 for:    "Neuromuscular Disease" | "Norepinephrine"

Safety and Efficacy Study of ADL5859 in Participants With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

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: NCT00603265
Recruitment Status : Completed
First Posted : January 29, 2008
Results First Posted : July 1, 2015
Last Update Posted : July 1, 2015
Sponsor:
Information provided by (Responsible Party):
Cubist Pharmaceuticals LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Peripheral Neuropathy
Neuropathic Pain
Interventions Drug: ADL5859
Drug: Duloxetine
Drug: Placebo
Enrollment 226
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ADL5859 Duloxetine Placebo
Hide Arm/Group Description 2 x 50 milligrams (mg) ADL5859 capsules administered orally once in the morning and once in the evening for 28 days 2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days 2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
Period Title: Overall Study
Started 76 [1] 78 72
Received at Least 1 Dose of Study Drug 75 78 72
Completed 69 62 67
Not Completed 7 16 5
Reason Not Completed
Adverse Event             2             11             1
Withdrawal by Subject             1             2             1
Lack of Efficacy             3             0             3
Lost to Follow-up             0             1             0
Out of Town, Ran Out of Study Drug             0             1             0
Participant Left Country, No Responses             0             1             0
Protocol Violation             1             0             0
[1]
1 participant was randomized in error and did not receive study medication
Arm/Group Title ADL5859 Duloxetine Placebo Total
Hide Arm/Group Description 2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days 2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days 2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days Total of all reporting groups
Overall Number of Baseline Participants 75 78 72 225
Hide Baseline Analysis Population Description
All participants who were randomized and treated with study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 75 participants 78 participants 72 participants 225 participants
59.7  (10.17) 59.1  (8.71) 56.2  (8.78) 58.3  (9.33)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 78 participants 72 participants 225 participants
Female
35
  46.7%
39
  50.0%
27
  37.5%
101
  44.9%
Male
40
  53.3%
39
  50.0%
45
  62.5%
124
  55.1%
1.Primary Outcome
Title Change From Baseline in Mean Numeric Pain Rating Scale (NPRS) Score
Hide Description The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain. The mean of the daily average scores were calculated from the NPRS pain assessments obtained up to 3 times per day over a 7-day period. Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with treatment group as a main factor and baseline NPRS score as a covariate. Change from Baseline = NPRS at baseline - NPRS at Week 4; a positive number in the LS mean indicates a reduction in pain intensity from baseline.
Time Frame Baseline, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study medication and had evaluable NPRS data. Baseline-observation-carried-forward (BOCF) was used to impute missing postbaseline values for participants who were discontinued from the study early.
Arm/Group Title ADL5859 Duloxetine Placebo
Hide Arm/Group Description:
2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
Overall Number of Participants Analyzed 75 77 72
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
1.02  (0.225) 1.74  (0.221) 1.51  (0.229)
2.Secondary Outcome
Title Percentage of Responders
Hide Description A responder was defined as a participant who showed a reduction in average pain (as measured by NPRS) of at least 30% from baseline to Week 4. The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain. The percentage of participants who qualified as responders is presented per treatment arm.
Time Frame Baseline, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study medication, completed the 4-week treatment period, and had evaluable NPRS data.
Arm/Group Title ADL5859 Duloxetine Placebo
Hide Arm/Group Description:
2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
Overall Number of Participants Analyzed 69 63 67
Measure Type: Number
Unit of Measure: percentage of participants
26.1 52.4 38.8
3.Secondary Outcome
Title Patient Global Impression of Change (PGIC)
Hide Description PGIC is a participant-rated instrument that measures the change in the participant’s overall status for the previous 2 weeks based on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). The number of participants in each category is presented.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study medication, completed the 4-week treatment period, and had evaluable PGIC data.
Arm/Group Title ADL5859 Duloxetine Placebo
Hide Arm/Group Description:
2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
Overall Number of Participants Analyzed 69 63 67
Measure Type: Number
Unit of Measure: participants
Very Much Improved 7 11 11
Much Improved 20 15 11
Minimally Improved 20 17 22
No Change 19 14 21
Minimally Worse 0 2 0
Much Worse 3 1 1
Very Much Worse 0 1 0
Not Reported 0 2 1
4.Secondary Outcome
Title Change in Sleep Interference Scale (SIS) From Baseline
Hide Description Sleep Interference was assessed on an 11-point Numeric Rating Scale where a score of 0 indicated "pain did not interfere with sleep" and a score of 10 indicated "pain completely interfered with sleep". Here, "n" signifies "Number of participants" for Baseline and Month 3 telephone interview whereas "n" signifies "number of observations" for Month 1, 2, and 3 because a participant could have had multiple visits during Month 1, 2, and 3 as this was a non-interventional study with no scheduled study visits, except Baseline visit and the Month 3 telephone interview. LS means were calculated using ANCOVA with treatment group as a main factor and baseline SIS score as a covariate. Change from baseline = SIS score at baseline - SIS score at Week 4.
Time Frame Baseline, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study medication, completed the 4-week treatment period, and had evaluable SIS data
Arm/Group Title ADL5859 Duloxetine Placebo
Hide Arm/Group Description:
2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
Overall Number of Participants Analyzed 69 63 66
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
1.92  (0.291) 2.27  (0.304) 1.56  (0.297)
5.Secondary Outcome
Title Change From Baseline in the Evening Assessment of the 24-hour Overall Mean Pain Intensity Score
Hide Description At each of the evening pain assessments, participants assessed their overall pain intensity over the preceding 24 hours using NPRS. The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain. The mean of the daily average scores were calculated from the NPRS pain assessments obtained at Baseline and Week 4. Change from baseline = NPRS at baseline - NPRS at Week 4.
Time Frame Baseline, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study medication and had evaluable 24-hour NPRS data.
Arm/Group Title ADL5859 Duloxetine Placebo
Hide Arm/Group Description:
2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
Overall Number of Participants Analyzed 69 63 67
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.09  (1.847) 2.15  (2.322) 1.51  (2.027)
6.Secondary Outcome
Title Change From Baseline in NPRS at Rest in the Clinic
Hide Description The mean of the daily average scores were calculated from the NPRS pain assessments obtained 1 time per week over a 4-week period. NPRS assessments were taken while the participant was at rest. The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain. LS means were calculated using ANCOVA with treatment group as a main factor and baseline NPRS score as a covariate. Change from baseline = NPRS at baseline - NPRS at Weeks 1, 2, 3, and 4.
Time Frame Baseline, Week 1, Week 2, Week 3, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study medication, completed the 4-week treatment period, and had evaluable at-rest NPRS data.
Arm/Group Title ADL5859 Duloxetine Placebo
Hide Arm/Group Description:
2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
Overall Number of Participants Analyzed 69 63 67
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 1 (n=67, 59, 64) 0.70  (0.200) 1.15  (0.213) 0.75  (0.205)
Week 2 (n=68, 61, 65) 0.80  (0.237) 1.44  (0.250) 1.16  (0.243)
Week 3 (n=67, 61, 63) 0.92  (0.265) 1.95  (0.277) 1.27  (0.274)
Week 4 (n=68, 61, 65) 1.13  (0.269) 2.03  (0.283) 1.59  (0.276)
7.Secondary Outcome
Title Change From Baseline in NPRS After Walking 50 Feet in the Clinic
Hide Description The mean of the daily average scores were calculated from the NPRS pain assessments obtained 1 time per week over a 4-week period. NPRS assessments were taken after the participant walked 50 feet in the clinic. The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain. LS means were calculated using ANCOVA with treatment group as a main factor and baseline NPRS score as a covariate. Change from baseline = NPRS at baseline - NPRS at Weeks 1, 2, 3, and 4.
Time Frame Baseline, Week 1, Week 2, Week 3, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study medication, completed the 4-week treatment period, and had evaluable post-walk NPRS data.
Arm/Group Title ADL5859 Duloxetine Placebo
Hide Arm/Group Description:
2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
Overall Number of Participants Analyzed 69 63 67
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 1 (n=67, 59, 64) 0.88  (0.215) 1.42  (0.229) 1.00  (0.220)
Week 2 (n=67, 61, 65) 0.93  (0.254) 1.75  (0.267) 1.23  (0.259)
Week 3 (n=67, 61, 63) 1.24  (0.281) 2.25  (0.294) 1.43  (0.290)
Week 4 (n=68, 61, 65) 1.29  (0.273) 2.36  (0.288) 1.79  (0.279)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ADL5859 Duloxetine Placebo
Hide Arm/Group Description 2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days 2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days 2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
All-Cause Mortality
ADL5859 Duloxetine Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ADL5859 Duloxetine Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/75 (0.00%)   1/78 (1.28%)   0/72 (0.00%) 
Blood and lymphatic system disorders       
Iron Deficiency Anaemia   0/75 (0.00%)  1/78 (1.28%)  0/72 (0.00%) 
Cardiac disorders       
Arrhythmia  [1]  0/75 (0.00%)  1/78 (1.28%)  0/72 (0.00%) 
Indicates events were collected by systematic assessment
[1]
Resulted in one death in the duloxetine group.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ADL5859 Duloxetine Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   27/75 (36.00%)   28/78 (35.90%)   27/72 (37.50%) 
Blood and lymphatic system disorders       
Thrombocytopenia   1/75 (1.33%)  0/78 (0.00%)  0/72 (0.00%) 
Cardiac disorders       
Atrioventricular block first degree   0/75 (0.00%)  0/78 (0.00%)  1/72 (1.39%) 
Bradycardia   1/75 (1.33%)  0/78 (0.00%)  0/72 (0.00%) 
Bundle branch block   0/75 (0.00%)  0/78 (0.00%)  1/72 (1.39%) 
Palpitations   1/75 (1.33%)  2/78 (2.56%)  1/72 (1.39%) 
Ventricular extrasystoles   0/75 (0.00%)  1/78 (1.28%)  0/72 (0.00%) 
Ear and labyrinth disorders       
Ear pain   0/75 (0.00%)  1/78 (1.28%)  0/72 (0.00%) 
Tinnitus   0/75 (0.00%)  0/78 (0.00%)  1/72 (1.39%) 
Vertigo   1/75 (1.33%)  0/78 (0.00%)  0/72 (0.00%) 
Eye disorders       
Keratitis   0/75 (0.00%)  0/78 (0.00%)  1/72 (1.39%) 
Retinopathy   0/75 (0.00%)  1/78 (1.28%)  0/72 (0.00%) 
Visual acuity reduced   0/75 (0.00%)  1/78 (1.28%)  0/72 (0.00%) 
Gastrointestinal disorders       
Abdominal distension   1/75 (1.33%)  0/78 (0.00%)  0/72 (0.00%) 
Abdominal pain lower   1/75 (1.33%)  0/78 (0.00%)  0/72 (0.00%) 
Abdominal pain upper   0/75 (0.00%)  1/78 (1.28%)  0/72 (0.00%) 
Constipation   2/75 (2.67%)  3/78 (3.85%)  1/72 (1.39%) 
Diarrhoea   4/75 (5.33%)  9/78 (11.54%)  3/72 (4.17%) 
Dry mouth   0/75 (0.00%)  1/78 (1.28%)  0/72 (0.00%) 
Dysgeusia   0/75 (0.00%)  1/78 (1.28%)  0/72 (0.00%) 
Erosive oesophagitis   0/75 (0.00%)  1/78 (1.28%)  0/72 (0.00%) 
Nausea   1/75 (1.33%)  16/78 (20.51%)  3/72 (4.17%) 
Stomach discomfort   0/75 (0.00%)  0/78 (0.00%)  1/72 (1.39%) 
Vomiting   1/75 (1.33%)  2/78 (2.56%)  0/72 (0.00%) 
General disorders       
Asthenia   1/75 (1.33%)  3/78 (3.85%)  1/72 (1.39%) 
Fatigue   1/75 (1.33%)  3/78 (3.85%)  3/72 (4.17%) 
Feeling hot   0/75 (0.00%)  0/78 (0.00%)  1/72 (1.39%) 
Non-cardiac chest pain   1/75 (1.33%)  0/78 (0.00%)  0/72 (0.00%) 
Oedema peripheral   1/75 (1.33%)  2/78 (2.56%)  2/72 (2.78%) 
Immune system disorders       
Seasonal allergy   1/75 (1.33%)  0/78 (0.00%)  0/72 (0.00%) 
Infections and infestations       
Bronchitis   1/75 (1.33%)  0/78 (0.00%)  2/72 (2.78%) 
Cellulitis   0/75 (0.00%)  0/78 (0.00%)  1/72 (1.39%) 
Gastroenteritis   0/75 (0.00%)  1/78 (1.28%)  0/72 (0.00%) 
Gastroenteritis viral   1/75 (1.33%)  1/78 (1.28%)  0/72 (0.00%) 
Labyrinthitis   0/75 (0.00%)  1/78 (1.28%)  0/72 (0.00%) 
Lower respiratory tract infection   1/75 (1.33%)  0/78 (0.00%)  0/72 (0.00%) 
Nasopharyngitis   1/75 (1.33%)  0/78 (0.00%)  3/72 (4.17%) 
Onychomycosis   0/75 (0.00%)  0/78 (0.00%)  1/72 (1.39%) 
Oral herpes   0/75 (0.00%)  0/78 (0.00%)  1/72 (1.39%) 
Pharyngitis   0/75 (0.00%)  0/78 (0.00%)  1/72 (1.39%) 
Sinusitis   0/75 (0.00%)  1/78 (1.28%)  0/72 (0.00%) 
Upper respiratory tract infection   1/75 (1.33%)  1/78 (1.28%)  2/72 (2.78%) 
Urinary tract infection   2/75 (2.67%)  2/78 (2.56%)  2/72 (2.78%) 
Viral infection   1/75 (1.33%)  0/78 (0.00%)  0/72 (0.00%) 
Vulvovaginal mycotic infection   1/35 (2.86%)  0/39 (0.00%)  0/27 (0.00%) 
Injury, poisoning and procedural complications       
Contusion   1/75 (1.33%)  0/78 (0.00%)  0/72 (0.00%) 
Fall   0/75 (0.00%)  1/78 (1.28%)  0/72 (0.00%) 
Limb injury   0/75 (0.00%)  0/78 (0.00%)  1/72 (1.39%) 
Muscle strain   0/75 (0.00%)  0/78 (0.00%)  1/72 (1.39%) 
Post-traumatic pain   1/75 (1.33%)  0/78 (0.00%)  0/72 (0.00%) 
Investigations       
Alanine aminotransferase increased   1/75 (1.33%)  0/78 (0.00%)  0/72 (0.00%) 
Blood creatinine increased   0/75 (0.00%)  0/78 (0.00%)  1/72 (1.39%) 
Blood glucose increased   0/75 (0.00%)  1/78 (1.28%)  1/72 (1.39%) 
Blood potassium increased   0/75 (0.00%)  0/78 (0.00%)  1/72 (1.39%) 
Blood urea increased   0/75 (0.00%)  0/78 (0.00%)  1/72 (1.39%) 
Eosinophil count increased   3/75 (4.00%)  0/78 (0.00%)  0/72 (0.00%) 
Haematocrit decreased   0/75 (0.00%)  1/78 (1.28%)  0/72 (0.00%) 
Haemoglobin decreased   0/75 (0.00%)  1/78 (1.28%)  0/72 (0.00%) 
Red blood cell count decreased   0/75 (0.00%)  1/78 (1.28%)  0/72 (0.00%) 
Metabolism and nutrition disorders       
Anorexia   0/75 (0.00%)  1/78 (1.28%)  0/72 (0.00%) 
Decreased appetite   0/75 (0.00%)  3/78 (3.85%)  1/72 (1.39%) 
Hypoglycaemia   1/75 (1.33%)  2/78 (2.56%)  0/72 (0.00%) 
Musculoskeletal and connective tissue disorders       
Back pain   1/75 (1.33%)  1/78 (1.28%)  1/72 (1.39%) 
Bursitis   0/75 (0.00%)  0/78 (0.00%)  1/72 (1.39%) 
Muscle spasms   0/75 (0.00%)  0/78 (0.00%)  3/72 (4.17%) 
Muscular weakness   1/75 (1.33%)  0/78 (0.00%)  0/72 (0.00%) 
Pain in extremity   0/75 (0.00%)  0/78 (0.00%)  1/72 (1.39%) 
Tendonitis   0/75 (0.00%)  0/78 (0.00%)  1/72 (1.39%) 
Nervous system disorders       
Dizziness   1/75 (1.33%)  5/78 (6.41%)  0/72 (0.00%) 
Dysarthria   0/75 (0.00%)  0/78 (0.00%)  1/72 (1.39%) 
Essential tremor   0/75 (0.00%)  1/78 (1.28%)  0/72 (0.00%) 
Headache   4/75 (5.33%)  6/78 (7.69%)  2/72 (2.78%) 
Hypoaesthesia   0/75 (0.00%)  1/78 (1.28%)  0/72 (0.00%) 
Somnolence   0/75 (0.00%)  3/78 (3.85%)  0/72 (0.00%) 
Tremor   0/75 (0.00%)  3/78 (3.85%)  0/72 (0.00%) 
Psychiatric disorders       
Abnormal dreams   0/75 (0.00%)  0/78 (0.00%)  2/72 (2.78%) 
Anxiety   1/75 (1.33%)  0/78 (0.00%)  2/72 (2.78%) 
Confusional state   0/75 (0.00%)  0/78 (0.00%)  1/72 (1.39%) 
Depression   0/75 (0.00%)  0/78 (0.00%)  1/72 (1.39%) 
Insomnia   0/75 (0.00%)  2/78 (2.56%)  2/72 (2.78%) 
Renal and urinary disorders       
Micturition urgency   0/75 (0.00%)  0/78 (0.00%)  1/72 (1.39%) 
Pollakiuria   0/75 (0.00%)  0/78 (0.00%)  1/72 (1.39%) 
Proteinuria   0/75 (0.00%)  1/78 (1.28%)  0/72 (0.00%) 
Renal failure   0/75 (0.00%)  1/78 (1.28%)  0/72 (0.00%) 
Urinary incontinence   0/75 (0.00%)  0/78 (0.00%)  1/72 (1.39%) 
Reproductive system and breast disorders       
Libido decreased   0/75 (0.00%)  1/78 (1.28%)  0/72 (0.00%) 
Ovarian cyst   0/35 (0.00%)  0/39 (0.00%)  1/27 (3.70%) 
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease   0/75 (0.00%)  1/78 (1.28%)  0/72 (0.00%) 
Cough   2/75 (2.67%)  0/78 (0.00%)  0/72 (0.00%) 
Dyspnoea   0/75 (0.00%)  0/78 (0.00%)  1/72 (1.39%) 
Nasal inflammation   0/75 (0.00%)  1/78 (1.28%)  0/72 (0.00%) 
Throat irritation   1/75 (1.33%)  0/78 (0.00%)  0/72 (0.00%) 
Wheezing   0/75 (0.00%)  1/78 (1.28%)  0/72 (0.00%) 
Skin and subcutaneous tissue disorders       
Cold sweat   0/75 (0.00%)  1/78 (1.28%)  0/72 (0.00%) 
Dry skin   1/75 (1.33%)  0/78 (0.00%)  0/72 (0.00%) 
Dyshidrosis   1/75 (1.33%)  0/78 (0.00%)  0/72 (0.00%) 
Hyperhidrosis   0/75 (0.00%)  2/78 (2.56%)  0/72 (0.00%) 
Pruritus   1/75 (1.33%)  0/78 (0.00%)  3/72 (4.17%) 
Rash   0/75 (0.00%)  1/78 (1.28%)  0/72 (0.00%) 
Rash erythematous   0/75 (0.00%)  0/78 (0.00%)  2/72 (2.78%) 
Urticaria   0/75 (0.00%)  0/78 (0.00%)  1/72 (1.39%) 
Vascular disorders       
Hypertension   2/75 (2.67%)  0/78 (0.00%)  0/72 (0.00%) 
Hypotension   0/75 (0.00%)  1/78 (1.28%)  0/72 (0.00%) 
Orthostatic hypotension   7/75 (9.33%)  6/78 (7.69%)  6/72 (8.33%) 
Indicates events were collected by systematic assessment
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.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Vice President, Clinical Research
Organization: Cubist Pharmaceuticals
Phone: (781) 860-8660
Layout table for additonal information
Responsible Party: Cubist Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT00603265     History of Changes
Other Study ID Numbers: 33CL231
First Submitted: January 17, 2008
First Posted: January 29, 2008
Results First Submitted: April 21, 2015
Results First Posted: July 1, 2015
Last Update Posted: July 1, 2015