Trial Outcomes & Findings for Effectiveness and Safety Study of Pentosan Polysulfate Sodium for the Treatment of Interstitial Cystitis (NCT NCT00086684)
NCT ID: NCT00086684
Last Updated: 2014-04-21
Results Overview
The ICSI is a four-item self-administered instrument developed for the evaluation and management of patients with interstitial cystitis. The index measures the presence and extent of symptoms including urinary urgency, urinary frequency, nocturia and pain/burning in the bladder. Each question in the ICSI is on a 0-5 scale, where each answer is given a specific rating. The sum of the individual question ratings is the score for the ICSI. The range of the test is a score of 0 to 20. A lower score indicates a better condition.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
369 participants
Primary outcome timeframe
Baseline to Week 24
Results posted on
2014-04-21
Participant Flow
Three hundred and sixty-nine patients enrolled in this study. One patient did not take any study drug. Therefore, only 368 patients were included in the primary analysis dataset.
Participant milestones
| Measure |
PLACEBO
|
Pentosan Polysulfate Sodium (ELMIRON) 100MG QD
One 100 mg pentosan polysulfate sodium capsule QD (once daily)
|
Pentosan Polysulfate Sodium (ELMIRON) 100MG TID
One 100 mg pentosan polysulfate sodium capsule TID (three times a day)
|
|---|---|---|---|
|
Overall Study
STARTED
|
118
|
129
|
122
|
|
Overall Study
COMPLETED
|
63
|
74
|
69
|
|
Overall Study
NOT COMPLETED
|
55
|
55
|
53
|
Reasons for withdrawal
| Measure |
PLACEBO
|
Pentosan Polysulfate Sodium (ELMIRON) 100MG QD
One 100 mg pentosan polysulfate sodium capsule QD (once daily)
|
Pentosan Polysulfate Sodium (ELMIRON) 100MG TID
One 100 mg pentosan polysulfate sodium capsule TID (three times a day)
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
12
|
17
|
14
|
|
Overall Study
Lack of Efficacy
|
6
|
6
|
5
|
|
Overall Study
Lost to Follow-up
|
15
|
8
|
10
|
|
Overall Study
Protocol Violation
|
8
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
4
|
10
|
|
Overall Study
NONCOMPLIANCE
|
5
|
7
|
6
|
|
Overall Study
STUDY TERMINATED BY SPONSOR
|
0
|
1
|
0
|
|
Overall Study
WITHDRAWAL OF CONSENT
|
5
|
7
|
5
|
|
Overall Study
Other
|
4
|
2
|
3
|
Baseline Characteristics
Effectiveness and Safety Study of Pentosan Polysulfate Sodium for the Treatment of Interstitial Cystitis
Baseline characteristics by cohort
| Measure |
PLACEBO
n=118 Participants
|
Pentosan Polysulfate Sodium (ELMIRON) 100MG QD
n=129 Participants
One 100 mg pentosan polysulfate sodium capsule QD (once daily)
|
Pentosan Polysulfate Sodium (ELMIRON) 100MG TID
n=122 Participants
One 100 mg pentosan polysulfate sodium capsule TID (three times a day)
|
Total
n=369 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
103 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
320 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Age, Continuous
|
44.6 years
STANDARD_DEVIATION 14.58 • n=5 Participants
|
45.6 years
STANDARD_DEVIATION 15.68 • n=7 Participants
|
42.7 years
STANDARD_DEVIATION 15.71 • n=5 Participants
|
44.3 years
STANDARD_DEVIATION 15.35 • n=4 Participants
|
|
Sex: Female, Male
Female
|
101 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
333 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
AgeCategorical
<18 YEARS
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
AgeCategorical
18-<64 YEARS
|
104 participants
n=5 Participants
|
109 participants
n=7 Participants
|
109 participants
n=5 Participants
|
322 participants
n=4 Participants
|
|
AgeCategorical
65-<74 YEARS
|
10 participants
n=5 Participants
|
17 participants
n=7 Participants
|
11 participants
n=5 Participants
|
38 participants
n=4 Participants
|
|
AgeCategorical
>=75 YEARS
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
Baseline BMI
|
27 kg/cm2
STANDARD_DEVIATION 6.50 • n=5 Participants
|
26.8 kg/cm2
STANDARD_DEVIATION 9.42 • n=7 Participants
|
27.1 kg/cm2
STANDARD_DEVIATION 11.02 • n=5 Participants
|
26.9 kg/cm2
STANDARD_DEVIATION 9.18 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 24Population: Intent-to-Treat (ITT) Analysis set
The ICSI is a four-item self-administered instrument developed for the evaluation and management of patients with interstitial cystitis. The index measures the presence and extent of symptoms including urinary urgency, urinary frequency, nocturia and pain/burning in the bladder. Each question in the ICSI is on a 0-5 scale, where each answer is given a specific rating. The sum of the individual question ratings is the score for the ICSI. The range of the test is a score of 0 to 20. A lower score indicates a better condition.
Outcome measures
| Measure |
PLACEBO
n=118 Participants
|
Pentosan Polysulfate Sodium (ELMIRON) 100MG QD
n=128 Participants
One 100 mg pentosan polysulfate sodium capsule QD (once daily)
|
Pentosan Polysulfate Sodium (ELMIRON) 100MG TID
n=122 Participants
One 100 mg pentosan polysulfate sodium capsule TID (three times a day)
|
|---|---|---|---|
|
Number of Responders Defined as Having at Least a 30% Reduction in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) From Baseline to Study Endpoint
|
48 participants
|
51 participants
|
52 participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Intent-to-Treat (ITT) Analysis set
The ICSI is a four-item self-administered instrument developed for the evaluation and management of patients with interstitial cystitis. The index measures the presence and extent of symptoms including urinary urgency, urinary frequency, nocturia and pain/burning in the bladder. Each question in the ICSI is on a 0-5 scale, where each answer is given a specific rating. The sum of the individual question ratings is the score for the ICSI. The range of the test is a score of 0 to 20. A lower score indicates a better condition.
Outcome measures
| Measure |
PLACEBO
n=118 Participants
|
Pentosan Polysulfate Sodium (ELMIRON) 100MG QD
n=128 Participants
One 100 mg pentosan polysulfate sodium capsule QD (once daily)
|
Pentosan Polysulfate Sodium (ELMIRON) 100MG TID
n=122 Participants
One 100 mg pentosan polysulfate sodium capsule TID (three times a day)
|
|---|---|---|---|
|
Number of Responders Defined as Having at Least a Four Point Reduction in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) From Baseline to Study Endpoint
|
55 participants
|
55 participants
|
60 participants
|
Adverse Events
PLACEBO
Serious events: 4 serious events
Other events: 95 other events
Deaths: 0 deaths
Pentosan Polysulfate Sodium (ELMIRON) 100MG QD
Serious events: 4 serious events
Other events: 107 other events
Deaths: 0 deaths
Pentosan Polysulfate Sodium (ELMIRON) 100MG TID
Serious events: 0 serious events
Other events: 97 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PLACEBO
n=118 participants at risk
|
Pentosan Polysulfate Sodium (ELMIRON) 100MG QD
n=128 participants at risk
One 100 mg pentosan polysulfate sodium capsule QD (once daily)
|
Pentosan Polysulfate Sodium (ELMIRON) 100MG TID
n=122 participants at risk
One 100 mg pentosan polysulfate sodium capsule TID (three times a day)
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/118
|
0.78%
1/128
|
0.00%
0/122
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/118
|
0.78%
1/128
|
0.00%
0/122
|
|
General disorders
Chest Pain
|
0.00%
0/118
|
0.78%
1/128
|
0.00%
0/122
|
|
General disorders
Pyrexia
|
0.00%
0/118
|
0.78%
1/128
|
0.00%
0/122
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.85%
1/118
|
0.00%
0/128
|
0.00%
0/122
|
|
Hepatobiliary disorders
Gallbladder Cholesterolosis
|
0.85%
1/118
|
0.00%
0/128
|
0.00%
0/122
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/118
|
0.78%
1/128
|
0.00%
0/122
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/118
|
0.78%
1/128
|
0.00%
0/122
|
|
Psychiatric disorders
Depression
|
0.85%
1/118
|
0.00%
0/128
|
0.00%
0/122
|
|
Psychiatric disorders
Homicidal Ideation
|
0.85%
1/118
|
0.00%
0/128
|
0.00%
0/122
|
|
Renal and urinary disorders
Renal Mass
|
0.00%
0/118
|
0.78%
1/128
|
0.00%
0/122
|
|
Renal and urinary disorders
Urinary Retention
|
0.85%
1/118
|
0.00%
0/128
|
0.00%
0/122
|
Other adverse events
| Measure |
PLACEBO
n=118 participants at risk
|
Pentosan Polysulfate Sodium (ELMIRON) 100MG QD
n=128 participants at risk
One 100 mg pentosan polysulfate sodium capsule QD (once daily)
|
Pentosan Polysulfate Sodium (ELMIRON) 100MG TID
n=122 participants at risk
One 100 mg pentosan polysulfate sodium capsule TID (three times a day)
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/118
|
0.78%
1/128
|
0.00%
0/122
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.85%
1/118
|
0.78%
1/128
|
0.82%
1/122
|
|
Congenital, familial and genetic disorders
Stargardt's Disease
|
0.85%
1/118
|
0.00%
0/128
|
0.00%
0/122
|
|
Ear and labyrinth disorders
Deafness Unilateral
|
0.00%
0/118
|
0.78%
1/128
|
0.00%
0/122
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/118
|
0.78%
1/128
|
0.00%
0/122
|
|
Ear and labyrinth disorders
Motion Sickness
|
0.00%
0/118
|
0.78%
1/128
|
0.00%
0/122
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/118
|
0.78%
1/128
|
0.00%
0/122
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/118
|
1.6%
2/128
|
0.00%
0/122
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/118
|
0.78%
1/128
|
0.82%
1/122
|
|
Eye disorders
Conjunctival Hyperaemia
|
0.85%
1/118
|
0.00%
0/128
|
0.00%
0/122
|
|
Eye disorders
Dry Eye
|
0.00%
0/118
|
0.00%
0/128
|
0.82%
1/122
|
|
Eye disorders
Macular Degeneration
|
0.00%
0/118
|
0.78%
1/128
|
0.00%
0/122
|
|
Eye disorders
Vision Blurred
|
0.85%
1/118
|
0.78%
1/128
|
1.6%
2/122
|
|
Eye disorders
Visual Acuity Reduced
|
0.00%
0/118
|
0.78%
1/128
|
0.00%
0/122
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
1.7%
2/118
|
2.3%
3/128
|
1.6%
2/122
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.85%
1/118
|
1.6%
2/128
|
0.00%
0/122
|
|
Gastrointestinal disorders
Abdominal Pain
|
3.4%
4/118
|
2.3%
3/128
|
2.5%
3/122
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.85%
1/118
|
0.78%
1/128
|
0.00%
0/122
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/118
|
1.6%
2/128
|
2.5%
3/122
|
|
Gastrointestinal disorders
Abdominal Tenderness
|
0.85%
1/118
|
0.00%
0/128
|
0.00%
0/122
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/118
|
0.00%
0/128
|
0.82%
1/122
|
|
Gastrointestinal disorders
Constipation
|
1.7%
2/118
|
2.3%
3/128
|
0.00%
0/122
|
|
Gastrointestinal disorders
Dental Caries
|
0.00%
0/118
|
1.6%
2/128
|
0.00%
0/122
|
|
Gastrointestinal disorders
Diarrhoea
|
5.9%
7/118
|
10.2%
13/128
|
4.9%
6/122
|
|
Gastrointestinal disorders
Dry Mouth
|
0.85%
1/118
|
0.78%
1/128
|
0.82%
1/122
|
|
Gastrointestinal disorders
Dyspepsia
|
1.7%
2/118
|
1.6%
2/128
|
3.3%
4/122
|
|
Gastrointestinal disorders
Faeces Discoloured
|
0.85%
1/118
|
0.00%
0/128
|
0.00%
0/122
|
|
Gastrointestinal disorders
Flatulence
|
1.7%
2/118
|
0.00%
0/128
|
0.00%
0/122
|
|
Gastrointestinal disorders
Food Poisoning
|
0.00%
0/118
|
1.6%
2/128
|
0.00%
0/122
|
|
Gastrointestinal disorders
Frequent Bowel Movements
|
0.00%
0/118
|
0.78%
1/128
|
0.00%
0/122
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
0.00%
0/118
|
0.00%
0/128
|
0.82%
1/122
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/118
|
0.78%
1/128
|
0.00%
0/122
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/118
|
0.78%
1/128
|
0.00%
0/122
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.85%
1/118
|
0.00%
0/128
|
0.82%
1/122
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/118
|
0.00%
0/128
|
0.82%
1/122
|
|
Gastrointestinal disorders
Irritable Bowel Syndrome
|
0.00%
0/118
|
0.00%
0/128
|
0.82%
1/122
|
|
Gastrointestinal disorders
Nausea
|
7.6%
9/118
|
14.8%
19/128
|
9.8%
12/122
|
|
Gastrointestinal disorders
Oral Pain
|
0.00%
0/118
|
0.00%
0/128
|
0.82%
1/122
|
|
Gastrointestinal disorders
Tooth Impacted
|
0.00%
0/118
|
0.00%
0/128
|
0.82%
1/122
|
|
Gastrointestinal disorders
Toothache
|
2.5%
3/118
|
0.78%
1/128
|
0.82%
1/122
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
3/118
|
7.8%
10/128
|
3.3%
4/122
|
|
General disorders
Asthenia
|
0.00%
0/118
|
1.6%
2/128
|
0.00%
0/122
|
|
General disorders
Chest Discomfort
|
0.00%
0/118
|
0.00%
0/128
|
0.82%
1/122
|
|
General disorders
Chest Pain
|
0.85%
1/118
|
0.00%
0/128
|
0.00%
0/122
|
|
General disorders
Chills
|
0.00%
0/118
|
0.00%
0/128
|
0.82%
1/122
|
|
General disorders
Fatigue
|
1.7%
2/118
|
0.78%
1/128
|
1.6%
2/122
|
|
General disorders
Malaise
|
0.85%
1/118
|
0.00%
0/128
|
0.00%
0/122
|
|
General disorders
Oedema Peripheral
|
0.85%
1/118
|
0.78%
1/128
|
1.6%
2/122
|
|
General disorders
Pain
|
1.7%
2/118
|
0.78%
1/128
|
0.00%
0/122
|
|
General disorders
Pyrexia
|
0.85%
1/118
|
0.00%
0/128
|
0.00%
0/122
|
|
General disorders
Suprapubic Pain
|
0.00%
0/118
|
0.78%
1/128
|
0.00%
0/122
|
|
General disorders
Tenderness
|
0.85%
1/118
|
0.00%
0/128
|
0.00%
0/122
|
|
General disorders
Thirst
|
0.85%
1/118
|
0.00%
0/128
|
0.00%
0/122
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.85%
1/118
|
0.00%
0/128
|
0.00%
0/122
|
|
Immune system disorders
Hypersensitivity
|
0.85%
1/118
|
0.78%
1/128
|
0.00%
0/122
|
|
Immune system disorders
Seasonal Allergy
|
1.7%
2/118
|
0.00%
0/128
|
0.00%
0/122
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/118
|
0.78%
1/128
|
0.00%
0/122
|
|
Infections and infestations
Ear Infection
|
1.7%
2/118
|
1.6%
2/128
|
0.82%
1/122
|
|
Infections and infestations
Eye Infection
|
0.00%
0/118
|
1.6%
2/128
|
0.00%
0/122
|
|
Infections and infestations
Fungal Infection
|
0.85%
1/118
|
1.6%
2/128
|
0.00%
0/122
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/118
|
1.6%
2/128
|
0.82%
1/122
|
|
Infections and infestations
Gastroenteritis Viral
|
1.7%
2/118
|
0.78%
1/128
|
0.00%
0/122
|
|
Infections and infestations
Gingival Infection
|
0.00%
0/118
|
0.78%
1/128
|
0.00%
0/122
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/118
|
0.00%
0/128
|
2.5%
3/122
|
|
Infections and infestations
Localised Infection
|
0.85%
1/118
|
0.00%
0/128
|
0.00%
0/122
|
|
Infections and infestations
Oral Herpes
|
0.00%
0/118
|
0.00%
0/128
|
0.82%
1/122
|
|
Infections and infestations
Otitis Externa
|
0.85%
1/118
|
0.00%
0/128
|
0.00%
0/122
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/118
|
1.6%
2/128
|
0.00%
0/122
|
|
Infections and infestations
Pharyngitis Streptococcal
|
1.7%
2/118
|
3.1%
4/128
|
0.82%
1/122
|
|
Infections and infestations
Purulent Discharge
|
0.85%
1/118
|
0.00%
0/128
|
0.00%
0/122
|
|
Infections and infestations
Pyelonephritis
|
0.85%
1/118
|
0.00%
0/128
|
0.00%
0/122
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/118
|
0.78%
1/128
|
1.6%
2/122
|
|
Infections and infestations
Tooth Abscess
|
0.00%
0/118
|
0.00%
0/128
|
2.5%
3/122
|
|
Infections and infestations
Tooth Infection
|
0.00%
0/118
|
0.78%
1/128
|
0.82%
1/122
|
|
Infections and infestations
Urinary Tract Infection
|
3.4%
4/118
|
7.0%
9/128
|
6.6%
8/122
|
|
Infections and infestations
Vaginitis Bacterial
|
0.00%
0/118
|
0.00%
0/128
|
0.82%
1/122
|
|
Infections and infestations
Viral Infection
|
0.85%
1/118
|
0.00%
0/128
|
0.00%
0/122
|
|
Infections and infestations
Vulvovaginal Mycotic Infection
|
0.00%
0/118
|
0.78%
1/128
|
2.5%
3/122
|
|
Injury, poisoning and procedural complications
Animal Bite
|
0.85%
1/118
|
0.00%
0/128
|
0.00%
0/122
|
|
Injury, poisoning and procedural complications
Contusion
|
0.85%
1/118
|
0.78%
1/128
|
0.82%
1/122
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/118
|
0.00%
0/128
|
1.6%
2/122
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.00%
0/118
|
0.78%
1/128
|
0.00%
0/122
|
|
Injury, poisoning and procedural complications
Joint Sprain
|
0.00%
0/118
|
0.78%
1/128
|
0.00%
0/122
|
|
Injury, poisoning and procedural complications
Laceration
|
0.85%
1/118
|
0.00%
0/128
|
0.82%
1/122
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
0.85%
1/118
|
0.78%
1/128
|
0.82%
1/122
|
|
Injury, poisoning and procedural complications
Tendon Injury
|
0.85%
1/118
|
0.00%
0/128
|
0.00%
0/122
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
0.00%
0/118
|
0.00%
0/128
|
0.82%
1/122
|
|
Investigations
Blood Cholesterol Increased
|
0.85%
1/118
|
0.00%
0/128
|
0.00%
0/122
|
|
Investigations
Blood Pressure Increased
|
1.7%
2/118
|
1.6%
2/128
|
0.00%
0/122
|
|
Investigations
Blood Pressure Systolic Increased
|
0.00%
0/118
|
0.00%
0/128
|
0.82%
1/122
|
|
Investigations
Blood Urine Present
|
0.00%
0/118
|
0.78%
1/128
|
0.00%
0/122
|
|
Investigations
Cardiac Murmur
|
0.85%
1/118
|
0.00%
0/128
|
0.00%
0/122
|
|
Investigations
Hepatic Enzyme Increased
|
0.85%
1/118
|
0.00%
0/128
|
0.00%
0/122
|
|
Investigations
Monocyte Count Increased
|
0.00%
0/118
|
0.00%
0/128
|
0.82%
1/122
|
|
Investigations
Prothrombin Time Prolonged
|
0.00%
0/118
|
0.00%
0/128
|
0.82%
1/122
|
|
Investigations
Smear Cervix Abnormal
|
0.85%
1/118
|
0.00%
0/128
|
0.00%
0/122
|
|
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus
|
0.00%
0/118
|
0.78%
1/128
|
0.00%
0/122
|
|
Metabolism and nutrition disorders
Vitamin B12 Deficiency
|
0.00%
0/118
|
0.00%
0/128
|
0.82%
1/122
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.85%
1/118
|
4.7%
6/128
|
0.00%
0/122
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/118
|
0.78%
1/128
|
0.82%
1/122
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.7%
2/118
|
5.5%
7/128
|
4.1%
5/122
|
|
Musculoskeletal and connective tissue disorders
Bunion
|
0.85%
1/118
|
0.00%
0/128
|
0.00%
0/122
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/118
|
0.00%
0/128
|
0.82%
1/122
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/118
|
2.3%
3/128
|
0.82%
1/122
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/118
|
1.6%
2/128
|
1.6%
2/122
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
1.7%
2/118
|
2.3%
3/128
|
0.82%
1/122
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/118
|
0.78%
1/128
|
0.00%
0/122
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
1.7%
2/118
|
0.00%
0/128
|
0.00%
0/122
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
4.2%
5/118
|
1.6%
2/128
|
0.82%
1/122
|
|
Musculoskeletal and connective tissue disorders
Pain in Jaw
|
0.85%
1/118
|
0.00%
0/128
|
0.00%
0/122
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.85%
1/118
|
0.78%
1/128
|
0.82%
1/122
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.85%
1/118
|
0.00%
0/128
|
0.00%
0/122
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mycosis Fungoides
|
0.00%
0/118
|
0.78%
1/128
|
0.00%
0/122
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyoma
|
0.85%
1/118
|
0.00%
0/128
|
0.00%
0/122
|
|
Nervous system disorders
Ataxia
|
0.85%
1/118
|
0.00%
0/128
|
0.00%
0/122
|
|
Nervous system disorders
Carpal Tunnel Syndrome
|
0.00%
0/118
|
0.78%
1/128
|
0.00%
0/122
|
|
Nervous system disorders
Dizziness
|
2.5%
3/118
|
1.6%
2/128
|
6.6%
8/122
|
|
Nervous system disorders
Headache
|
13.6%
16/118
|
12.5%
16/128
|
11.5%
14/122
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/118
|
0.78%
1/128
|
0.00%
0/122
|
|
Nervous system disorders
Hypoaesthesia
|
0.85%
1/118
|
0.00%
0/128
|
0.00%
0/122
|
|
Nervous system disorders
Insomnia
|
0.00%
0/118
|
1.6%
2/128
|
4.1%
5/122
|
|
Nervous system disorders
Lethargy
|
0.00%
0/118
|
0.78%
1/128
|
0.82%
1/122
|
|
Nervous system disorders
Migraine
|
1.7%
2/118
|
1.6%
2/128
|
0.82%
1/122
|
|
Nervous system disorders
Migraine with Aura
|
0.00%
0/118
|
0.78%
1/128
|
0.00%
0/122
|
|
Nervous system disorders
Presyncope
|
0.00%
0/118
|
0.78%
1/128
|
0.00%
0/122
|
|
Nervous system disorders
Restless Legs Syndrome
|
0.85%
1/118
|
0.00%
0/128
|
0.00%
0/122
|
|
Nervous system disorders
Sinus Headache
|
0.00%
0/118
|
0.78%
1/128
|
0.00%
0/122
|
|
Nervous system disorders
Somnolence
|
0.85%
1/118
|
0.00%
0/128
|
0.00%
0/122
|
|
Nervous system disorders
Syncope
|
0.00%
0/118
|
0.00%
0/128
|
0.82%
1/122
|
|
Psychiatric disorders
Anxiety
|
0.85%
1/118
|
0.78%
1/128
|
0.82%
1/122
|
|
Psychiatric disorders
Depression
|
0.85%
1/118
|
0.00%
0/128
|
0.82%
1/122
|
|
Psychiatric disorders
Libido Decreased
|
0.85%
1/118
|
0.78%
1/128
|
0.00%
0/122
|
|
Psychiatric disorders
Mood Swings
|
0.00%
0/118
|
0.00%
0/128
|
0.82%
1/122
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/118
|
0.00%
0/128
|
0.82%
1/122
|
|
Renal and urinary disorders
Bladder Discomfort
|
0.00%
0/118
|
0.78%
1/128
|
0.00%
0/122
|
|
Renal and urinary disorders
Bladder Pain
|
32.2%
38/118
|
27.3%
35/128
|
38.5%
47/122
|
|
Renal and urinary disorders
Bladder Prolapse
|
0.00%
0/118
|
0.00%
0/128
|
0.82%
1/122
|
|
Renal and urinary disorders
Cystitis
|
0.85%
1/118
|
0.78%
1/128
|
0.82%
1/122
|
|
Renal and urinary disorders
Cystitis Interstitial
|
9.3%
11/118
|
14.8%
19/128
|
7.4%
9/122
|
|
Renal and urinary disorders
Dysuria
|
1.7%
2/118
|
1.6%
2/128
|
2.5%
3/122
|
|
Renal and urinary disorders
Haematuria
|
0.85%
1/118
|
1.6%
2/128
|
0.00%
0/122
|
|
Renal and urinary disorders
Micturition Urgency
|
0.85%
1/118
|
0.78%
1/128
|
0.00%
0/122
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/118
|
0.00%
0/128
|
0.82%
1/122
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/118
|
0.78%
1/128
|
0.00%
0/122
|
|
Renal and urinary disorders
Urethral Pain
|
0.85%
1/118
|
0.00%
0/128
|
0.00%
0/122
|
|
Renal and urinary disorders
Urethral Ulcer
|
0.00%
0/118
|
0.78%
1/128
|
0.00%
0/122
|
|
Reproductive system and breast disorders
Atrophic Vulvovaginitis
|
0.00%
0/118
|
0.78%
1/128
|
0.82%
1/122
|
|
Reproductive system and breast disorders
Cervical Dysplasia
|
0.00%
0/118
|
0.00%
0/128
|
0.82%
1/122
|
|
Reproductive system and breast disorders
Cystocele
|
0.00%
0/118
|
0.00%
0/128
|
0.82%
1/122
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/118
|
2.3%
3/128
|
1.6%
2/122
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/118
|
0.00%
0/128
|
0.82%
1/122
|
|
Reproductive system and breast disorders
Menstrual Disorder
|
0.00%
0/118
|
0.00%
0/128
|
0.82%
1/122
|
|
Reproductive system and breast disorders
Menstruation Irregular
|
0.00%
0/118
|
0.00%
0/128
|
0.82%
1/122
|
|
Reproductive system and breast disorders
Spermatocele
|
0.85%
1/118
|
0.00%
0/128
|
0.00%
0/122
|
|
Reproductive system and breast disorders
Testicular Pain
|
0.85%
1/118
|
0.00%
0/128
|
0.00%
0/122
|
|
Reproductive system and breast disorders
Vaginal Haemorrhage
|
0.85%
1/118
|
0.78%
1/128
|
0.00%
0/122
|
|
Reproductive system and breast disorders
Vaginal Odour
|
0.85%
1/118
|
0.00%
0/128
|
0.00%
0/122
|
|
Reproductive system and breast disorders
Vulvovaginal Burning Sensation
|
0.00%
0/118
|
0.78%
1/128
|
0.00%
0/122
|
|
Reproductive system and breast disorders
Vulvovaginal Discomfort
|
0.85%
1/118
|
0.00%
0/128
|
0.00%
0/122
|
|
Reproductive system and breast disorders
Vulvovaginal Pain
|
0.00%
0/118
|
0.00%
0/128
|
0.82%
1/122
|
|
Reproductive system and breast disorders
Vulvovaginal Pruritus
|
0.85%
1/118
|
0.00%
0/128
|
0.82%
1/122
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
2.5%
3/118
|
1.6%
2/128
|
0.82%
1/122
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/118
|
1.6%
2/128
|
1.6%
2/122
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/118
|
0.78%
1/128
|
0.82%
1/122
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.85%
1/118
|
0.00%
0/128
|
1.6%
2/122
|
|
Respiratory, thoracic and mediastinal disorders
Influenza
|
5.1%
6/118
|
3.1%
4/128
|
2.5%
3/122
|
|
Respiratory, thoracic and mediastinal disorders
Lower Respiratory Tract Infection
|
1.7%
2/118
|
2.3%
3/128
|
0.82%
1/122
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.85%
1/118
|
1.6%
2/128
|
0.82%
1/122
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
1.7%
2/118
|
10.9%
14/128
|
5.7%
7/122
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.85%
1/118
|
1.6%
2/128
|
1.6%
2/122
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal Erythema
|
0.85%
1/118
|
0.00%
0/128
|
0.00%
0/122
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/118
|
0.00%
0/128
|
0.82%
1/122
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.7%
2/118
|
0.00%
0/128
|
0.00%
0/122
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
0.00%
0/118
|
0.78%
1/128
|
0.82%
1/122
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
5.9%
7/118
|
5.5%
7/128
|
4.1%
5/122
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Congestion
|
0.85%
1/118
|
0.00%
0/128
|
0.00%
0/122
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Infection
|
0.85%
1/118
|
2.3%
3/128
|
2.5%
3/122
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.85%
1/118
|
0.00%
0/128
|
0.00%
0/122
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.85%
1/118
|
2.3%
3/128
|
3.3%
4/122
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
0.85%
1/118
|
0.00%
0/128
|
0.00%
0/122
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/118
|
0.00%
0/128
|
1.6%
2/122
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.85%
1/118
|
0.78%
1/128
|
0.82%
1/122
|
|
Skin and subcutaneous tissue disorders
Hair Texture Abnormal
|
0.00%
0/118
|
0.78%
1/128
|
0.00%
0/122
|
|
Skin and subcutaneous tissue disorders
Heat Rash
|
0.00%
0/118
|
0.78%
1/128
|
0.00%
0/122
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.85%
1/118
|
1.6%
2/128
|
0.00%
0/122
|
|
Skin and subcutaneous tissue disorders
Idiopathic Urticaria
|
0.00%
0/118
|
0.00%
0/128
|
0.82%
1/122
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
0.85%
1/118
|
0.00%
0/128
|
0.00%
0/122
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.85%
1/118
|
1.6%
2/128
|
0.82%
1/122
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.7%
2/118
|
0.78%
1/128
|
2.5%
3/122
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.85%
1/118
|
0.00%
0/128
|
0.00%
0/122
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/118
|
0.78%
1/128
|
0.00%
0/122
|
|
Vascular disorders
Aortic Aneurysm
|
0.00%
0/118
|
0.78%
1/128
|
0.00%
0/122
|
|
Vascular disorders
Hot Flush
|
0.00%
0/118
|
1.6%
2/128
|
0.00%
0/122
|
|
Vascular disorders
Hypertension
|
0.85%
1/118
|
0.00%
0/128
|
1.6%
2/122
|
|
Vascular disorders
Hypotension
|
0.85%
1/118
|
0.00%
0/128
|
1.6%
2/122
|
Additional Information
SENIOR DIRECTOR CLINICAL LEADER
Janssen R&D US
Phone: 1 609 730-4529
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place