Trial Outcomes & Findings for Safety and Efficacy Study of ADL5859 in Participants With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy (NCT NCT00603265)
NCT ID: NCT00603265
Last Updated: 2015-07-01
Results Overview
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.
COMPLETED
PHASE2
226 participants
Baseline, Week 4
2015-07-01
Participant Flow
Participant milestones
| Measure |
ADL5859
2 x 50 milligrams (mg) ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
|
Duloxetine
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
|
Placebo
2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
|
|---|---|---|---|
|
Overall Study
STARTED
|
76
|
78
|
72
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
75
|
78
|
72
|
|
Overall Study
COMPLETED
|
69
|
62
|
67
|
|
Overall Study
NOT COMPLETED
|
7
|
16
|
5
|
Reasons for withdrawal
| Measure |
ADL5859
2 x 50 milligrams (mg) ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
|
Duloxetine
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
|
Placebo
2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
11
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
1
|
|
Overall Study
Lack of Efficacy
|
3
|
0
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
|
Overall Study
Out of Town, Ran Out of Study Drug
|
0
|
1
|
0
|
|
Overall Study
Participant Left Country, No Responses
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
Baseline Characteristics
Safety and Efficacy Study of ADL5859 in Participants With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
Baseline characteristics by cohort
| Measure |
ADL5859
n=75 Participants
2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
|
Duloxetine
n=78 Participants
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
|
Placebo
n=72 Participants
2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
|
Total
n=225 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
59.7 Years
STANDARD_DEVIATION 10.17 • n=5 Participants
|
59.1 Years
STANDARD_DEVIATION 8.71 • n=7 Participants
|
56.2 Years
STANDARD_DEVIATION 8.78 • n=5 Participants
|
58.3 Years
STANDARD_DEVIATION 9.33 • n=4 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
101 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
124 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 4Population: 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.
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.
Outcome measures
| Measure |
ADL5859
n=75 Participants
2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
|
Duloxetine
n=77 Participants
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
|
Placebo
n=72 Participants
2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
|
|---|---|---|---|
|
Change From Baseline in Mean Numeric Pain Rating Scale (NPRS) Score
|
1.02 units on a scale
Standard Error 0.225
|
1.74 units on a scale
Standard Error 0.221
|
1.51 units on a scale
Standard Error 0.229
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: All participants who received at least 1 dose of study medication, completed the 4-week treatment period, and had evaluable NPRS data.
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.
Outcome measures
| Measure |
ADL5859
n=69 Participants
2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
|
Duloxetine
n=63 Participants
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
|
Placebo
n=67 Participants
2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
|
|---|---|---|---|
|
Percentage of Responders
|
26.1 percentage of participants
|
52.4 percentage of participants
|
38.8 percentage of participants
|
SECONDARY outcome
Timeframe: Week 4Population: All participants who received at least 1 dose of study medication, completed the 4-week treatment period, and had evaluable PGIC data.
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.
Outcome measures
| Measure |
ADL5859
n=69 Participants
2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
|
Duloxetine
n=63 Participants
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
|
Placebo
n=67 Participants
2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
|
|---|---|---|---|
|
Patient Global Impression of Change (PGIC)
No Change
|
19 participants
|
14 participants
|
21 participants
|
|
Patient Global Impression of Change (PGIC)
Very Much Worse
|
0 participants
|
1 participants
|
0 participants
|
|
Patient Global Impression of Change (PGIC)
Not Reported
|
0 participants
|
2 participants
|
1 participants
|
|
Patient Global Impression of Change (PGIC)
Very Much Improved
|
7 participants
|
11 participants
|
11 participants
|
|
Patient Global Impression of Change (PGIC)
Much Improved
|
20 participants
|
15 participants
|
11 participants
|
|
Patient Global Impression of Change (PGIC)
Minimally Improved
|
20 participants
|
17 participants
|
22 participants
|
|
Patient Global Impression of Change (PGIC)
Minimally Worse
|
0 participants
|
2 participants
|
0 participants
|
|
Patient Global Impression of Change (PGIC)
Much Worse
|
3 participants
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: All participants who received at least 1 dose of study medication, completed the 4-week treatment period, and had evaluable SIS data
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.
Outcome measures
| Measure |
ADL5859
n=69 Participants
2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
|
Duloxetine
n=63 Participants
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
|
Placebo
n=66 Participants
2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
|
|---|---|---|---|
|
Change in Sleep Interference Scale (SIS) From Baseline
|
1.92 units on a scale
Standard Error 0.291
|
2.27 units on a scale
Standard Error 0.304
|
1.56 units on a scale
Standard Error 0.297
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: All participants who received at least 1 dose of study medication and had evaluable 24-hour NPRS data.
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.
Outcome measures
| Measure |
ADL5859
n=69 Participants
2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
|
Duloxetine
n=63 Participants
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
|
Placebo
n=67 Participants
2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
|
|---|---|---|---|
|
Change From Baseline in the Evening Assessment of the 24-hour Overall Mean Pain Intensity Score
|
1.09 units on a scale
Standard Deviation 1.847
|
2.15 units on a scale
Standard Deviation 2.322
|
1.51 units on a scale
Standard Deviation 2.027
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4Population: All participants who received at least 1 dose of study medication, completed the 4-week treatment period, and had evaluable at-rest NPRS data.
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.
Outcome measures
| Measure |
ADL5859
n=69 Participants
2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
|
Duloxetine
n=63 Participants
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
|
Placebo
n=67 Participants
2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
|
|---|---|---|---|
|
Change From Baseline in NPRS at Rest in the Clinic
Week 4 (n=68, 61, 65)
|
1.13 units on a scale
Standard Error 0.269
|
2.03 units on a scale
Standard Error 0.283
|
1.59 units on a scale
Standard Error 0.276
|
|
Change From Baseline in NPRS at Rest in the Clinic
Week 1 (n=67, 59, 64)
|
0.70 units on a scale
Standard Error 0.200
|
1.15 units on a scale
Standard Error 0.213
|
0.75 units on a scale
Standard Error 0.205
|
|
Change From Baseline in NPRS at Rest in the Clinic
Week 2 (n=68, 61, 65)
|
0.80 units on a scale
Standard Error 0.237
|
1.44 units on a scale
Standard Error 0.250
|
1.16 units on a scale
Standard Error 0.243
|
|
Change From Baseline in NPRS at Rest in the Clinic
Week 3 (n=67, 61, 63)
|
0.92 units on a scale
Standard Error 0.265
|
1.95 units on a scale
Standard Error 0.277
|
1.27 units on a scale
Standard Error 0.274
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4Population: All participants who received at least 1 dose of study medication, completed the 4-week treatment period, and had evaluable post-walk NPRS data.
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.
Outcome measures
| Measure |
ADL5859
n=69 Participants
2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
|
Duloxetine
n=63 Participants
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
|
Placebo
n=67 Participants
2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
|
|---|---|---|---|
|
Change From Baseline in NPRS After Walking 50 Feet in the Clinic
Week 1 (n=67, 59, 64)
|
0.88 units on a scale
Standard Error 0.215
|
1.42 units on a scale
Standard Error 0.229
|
1.00 units on a scale
Standard Error 0.220
|
|
Change From Baseline in NPRS After Walking 50 Feet in the Clinic
Week 2 (n=67, 61, 65)
|
0.93 units on a scale
Standard Error 0.254
|
1.75 units on a scale
Standard Error 0.267
|
1.23 units on a scale
Standard Error 0.259
|
|
Change From Baseline in NPRS After Walking 50 Feet in the Clinic
Week 3 (n=67, 61, 63)
|
1.24 units on a scale
Standard Error 0.281
|
2.25 units on a scale
Standard Error 0.294
|
1.43 units on a scale
Standard Error 0.290
|
|
Change From Baseline in NPRS After Walking 50 Feet in the Clinic
Week 4 (n=68, 61, 65)
|
1.29 units on a scale
Standard Error 0.273
|
2.36 units on a scale
Standard Error 0.288
|
1.79 units on a scale
Standard Error 0.279
|
Adverse Events
ADL5859
Duloxetine
Placebo
Serious adverse events
| Measure |
ADL5859
n=75 participants at risk
2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
|
Duloxetine
n=78 participants at risk
2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
|
Placebo
n=72 participants at risk
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
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/72
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/72
|
Other adverse events
| Measure |
ADL5859
n=75 participants at risk
2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
|
Duloxetine
n=78 participants at risk
2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
|
Placebo
n=72 participants at risk
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
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.3%
1/75
|
0.00%
0/78
|
0.00%
0/72
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/75
|
0.00%
0/78
|
1.4%
1/72
|
|
Cardiac disorders
Bradycardia
|
1.3%
1/75
|
0.00%
0/78
|
0.00%
0/72
|
|
Cardiac disorders
Bundle branch block
|
0.00%
0/75
|
0.00%
0/78
|
1.4%
1/72
|
|
Cardiac disorders
Palpitations
|
1.3%
1/75
|
2.6%
2/78
|
1.4%
1/72
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/72
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/72
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/75
|
0.00%
0/78
|
1.4%
1/72
|
|
Ear and labyrinth disorders
Vertigo
|
1.3%
1/75
|
0.00%
0/78
|
0.00%
0/72
|
|
Eye disorders
Keratitis
|
0.00%
0/75
|
0.00%
0/78
|
1.4%
1/72
|
|
Eye disorders
Retinopathy
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/72
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/72
|
|
Gastrointestinal disorders
Abdominal distension
|
1.3%
1/75
|
0.00%
0/78
|
0.00%
0/72
|
|
Gastrointestinal disorders
Abdominal pain lower
|
1.3%
1/75
|
0.00%
0/78
|
0.00%
0/72
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/72
|
|
Gastrointestinal disorders
Constipation
|
2.7%
2/75
|
3.8%
3/78
|
1.4%
1/72
|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
4/75
|
11.5%
9/78
|
4.2%
3/72
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/72
|
|
Gastrointestinal disorders
Dysgeusia
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/72
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/72
|
|
Gastrointestinal disorders
Nausea
|
1.3%
1/75
|
20.5%
16/78
|
4.2%
3/72
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.00%
0/75
|
0.00%
0/78
|
1.4%
1/72
|
|
Gastrointestinal disorders
Vomiting
|
1.3%
1/75
|
2.6%
2/78
|
0.00%
0/72
|
|
General disorders
Asthenia
|
1.3%
1/75
|
3.8%
3/78
|
1.4%
1/72
|
|
General disorders
Fatigue
|
1.3%
1/75
|
3.8%
3/78
|
4.2%
3/72
|
|
General disorders
Feeling hot
|
0.00%
0/75
|
0.00%
0/78
|
1.4%
1/72
|
|
General disorders
Non-cardiac chest pain
|
1.3%
1/75
|
0.00%
0/78
|
0.00%
0/72
|
|
General disorders
Oedema peripheral
|
1.3%
1/75
|
2.6%
2/78
|
2.8%
2/72
|
|
Immune system disorders
Seasonal allergy
|
1.3%
1/75
|
0.00%
0/78
|
0.00%
0/72
|
|
Infections and infestations
Bronchitis
|
1.3%
1/75
|
0.00%
0/78
|
2.8%
2/72
|
|
Infections and infestations
Cellulitis
|
0.00%
0/75
|
0.00%
0/78
|
1.4%
1/72
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/72
|
|
Infections and infestations
Gastroenteritis viral
|
1.3%
1/75
|
1.3%
1/78
|
0.00%
0/72
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/72
|
|
Infections and infestations
Lower respiratory tract infection
|
1.3%
1/75
|
0.00%
0/78
|
0.00%
0/72
|
|
Infections and infestations
Nasopharyngitis
|
1.3%
1/75
|
0.00%
0/78
|
4.2%
3/72
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/75
|
0.00%
0/78
|
1.4%
1/72
|
|
Infections and infestations
Oral herpes
|
0.00%
0/75
|
0.00%
0/78
|
1.4%
1/72
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/75
|
0.00%
0/78
|
1.4%
1/72
|
|
Infections and infestations
Sinusitis
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/72
|
|
Infections and infestations
Upper respiratory tract infection
|
1.3%
1/75
|
1.3%
1/78
|
2.8%
2/72
|
|
Infections and infestations
Urinary tract infection
|
2.7%
2/75
|
2.6%
2/78
|
2.8%
2/72
|
|
Infections and infestations
Viral infection
|
1.3%
1/75
|
0.00%
0/78
|
0.00%
0/72
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
2.9%
1/35
|
0.00%
0/39
|
0.00%
0/27
|
|
Injury, poisoning and procedural complications
Contusion
|
1.3%
1/75
|
0.00%
0/78
|
0.00%
0/72
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/72
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/75
|
0.00%
0/78
|
1.4%
1/72
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/75
|
0.00%
0/78
|
1.4%
1/72
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
1.3%
1/75
|
0.00%
0/78
|
0.00%
0/72
|
|
Investigations
Alanine aminotransferase increased
|
1.3%
1/75
|
0.00%
0/78
|
0.00%
0/72
|
|
Investigations
Blood creatinine increased
|
0.00%
0/75
|
0.00%
0/78
|
1.4%
1/72
|
|
Investigations
Blood glucose increased
|
0.00%
0/75
|
1.3%
1/78
|
1.4%
1/72
|
|
Investigations
Blood potassium increased
|
0.00%
0/75
|
0.00%
0/78
|
1.4%
1/72
|
|
Investigations
Blood urea increased
|
0.00%
0/75
|
0.00%
0/78
|
1.4%
1/72
|
|
Investigations
Eosinophil count increased
|
4.0%
3/75
|
0.00%
0/78
|
0.00%
0/72
|
|
Investigations
Haematocrit decreased
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/72
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/72
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/72
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/72
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/75
|
3.8%
3/78
|
1.4%
1/72
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.3%
1/75
|
2.6%
2/78
|
0.00%
0/72
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.3%
1/75
|
1.3%
1/78
|
1.4%
1/72
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/75
|
0.00%
0/78
|
1.4%
1/72
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/75
|
0.00%
0/78
|
4.2%
3/72
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.3%
1/75
|
0.00%
0/78
|
0.00%
0/72
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/75
|
0.00%
0/78
|
1.4%
1/72
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/75
|
0.00%
0/78
|
1.4%
1/72
|
|
Nervous system disorders
Dizziness
|
1.3%
1/75
|
6.4%
5/78
|
0.00%
0/72
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/75
|
0.00%
0/78
|
1.4%
1/72
|
|
Nervous system disorders
Essential tremor
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/72
|
|
Nervous system disorders
Headache
|
5.3%
4/75
|
7.7%
6/78
|
2.8%
2/72
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/72
|
|
Nervous system disorders
Somnolence
|
0.00%
0/75
|
3.8%
3/78
|
0.00%
0/72
|
|
Nervous system disorders
Tremor
|
0.00%
0/75
|
3.8%
3/78
|
0.00%
0/72
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/75
|
0.00%
0/78
|
2.8%
2/72
|
|
Psychiatric disorders
Anxiety
|
1.3%
1/75
|
0.00%
0/78
|
2.8%
2/72
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/75
|
0.00%
0/78
|
1.4%
1/72
|
|
Psychiatric disorders
Depression
|
0.00%
0/75
|
0.00%
0/78
|
1.4%
1/72
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/75
|
2.6%
2/78
|
2.8%
2/72
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/75
|
0.00%
0/78
|
1.4%
1/72
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/75
|
0.00%
0/78
|
1.4%
1/72
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/72
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/72
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/75
|
0.00%
0/78
|
1.4%
1/72
|
|
Reproductive system and breast disorders
Libido decreased
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/72
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/35
|
0.00%
0/39
|
3.7%
1/27
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/72
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.7%
2/75
|
0.00%
0/78
|
0.00%
0/72
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/75
|
0.00%
0/78
|
1.4%
1/72
|
|
Respiratory, thoracic and mediastinal disorders
Nasal inflammation
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/72
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
1.3%
1/75
|
0.00%
0/78
|
0.00%
0/72
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/72
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/72
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.3%
1/75
|
0.00%
0/78
|
0.00%
0/72
|
|
Skin and subcutaneous tissue disorders
Dyshidrosis
|
1.3%
1/75
|
0.00%
0/78
|
0.00%
0/72
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/75
|
2.6%
2/78
|
0.00%
0/72
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.3%
1/75
|
0.00%
0/78
|
4.2%
3/72
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/72
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/75
|
0.00%
0/78
|
2.8%
2/72
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/75
|
0.00%
0/78
|
1.4%
1/72
|
|
Vascular disorders
Hypertension
|
2.7%
2/75
|
0.00%
0/78
|
0.00%
0/72
|
|
Vascular disorders
Hypotension
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/72
|
|
Vascular disorders
Orthostatic hypotension
|
9.3%
7/75
|
7.7%
6/78
|
8.3%
6/72
|
Additional Information
Vice President, Clinical Research
Cubist Pharmaceuticals
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER