Effectiveness and Safety Study of Pentosan Polysulfate Sodium for the Treatment of Interstitial Cystitis

• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00086684
• Collaborator: (none)
• Enrollment: 369
• Locations: 65
• Arms: 3
• Duration (Months): 93
• Patients Per Site: 5.7
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of pentosan polysulfate sodium 100 mg once a day, pentosan polysulfate sodium 100 mg three times a day, and placebo for 24 weeks for the relief of bladder pain or discomfort associated with interstitial cystitis.

Condition or Disease	Intervention/Treatment	Phase
Interstitial Cystitis	Drug: Pentosan polysulfate sodium 100 mg; Drug: Placebo; Drug: Pentosan polysulfate sodium 100 mg	Phase 4

Detailed Description

The purpose of this multi-center, double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), randomized (patients are assigned different treatments based on chance), parallel group trial is to evaluate the effectiveness and safety of two doses of pentosan polysulfate sodium (100 mg once a day and 100 mg three times a day) versus placebo for 24 weeks for the relief of bladder pain or discomfort associated with interstitial cystitis. The hypothesis of the study is that there is no treatment difference in the proportion of responders at study endpoint (Week 24). Effectiveness will be assessed based on the reduction in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) total score. Safety assessments include vital signs, laboratory tests, adverse events and physical exams. Patients will receive one of the following study treatments by mouth each day for 24 weeks: pentosan polysulfate sodium 100 mg once a day group - one pentosan polysulfate sodium 100 mg capsule in the morning, and one matching placebo capsule in the afternoon and evening; pentosan polysulfate sodium 100 mg capsule three times a day group - one pentosan polysulfate sodium 100 mg capsule in the morning, afternoon and evening; placebo group - one placebo capsule in the morning, afternoon and evening

Study Design

• Study Type: Interventional
• Actual Enrollment: 369 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Randomized, Double-Blind, Placebo-Controlled, Parallel Group Evaluation of the Efficacy and Tolerability of Two Different Doses of ELMIRON for the Treatment of Interstitial Cystitis
• Study Start Date: Sep 1, 2003
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pentosan polysulfate sodium 100 mg once a day One 100 mg pentosan polysulfate sodium capsule in the morning and 1 matching placebo capsule in the afternoon and evening for 24 weeks	Drug: Pentosan polysulfate sodium 100 mg; One 100 mg pentosan polysulfate sodium capsule in the morning, and 1 matching placebo capsule in the afternoon and evening for 24 weeks
Experimental: Pentosan polysulfate sodium 100 mg three times a day One 100 mg pentosan polysulfate sodium capsule 3 times a day (morning afternoon and evening) for 24 weeks	Drug: Pentosan polysulfate sodium 100 mg; One 100 mg pentosan polysulfate sodium capsule 3 times a day (morning, afternoon, and evening) for 24 weeks
Placebo Comparator: Placebo Placebo One placebo capsule 3 times a day (morning afternoon and evening) for 24 weeks	Drug: Placebo; One placebo capsule 3 times a day (morning, afternoon and evening) for 24 weeks

Outcome Measures

Primary Outcome Measures

1. 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 [Baseline to Week 24]

   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.

Secondary Outcome Measures

1. 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 [Baseline to Week 24]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Must have a total score of 8 or greater on the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) and a score of > 0 on each of the 4 questions on the ICSI

• must have experienced bladder pain, urinary urgency and urinary frequency, each not related to a urinary tract infection, for at least 6 months prior to entry into the study

• must have averaged >= 10 voids per day (>=30 voids over 3 consecutive days) and averaged >= 1 void at night

• urine culture showing no evidence of urinary tract infection

• urine cytology showing no evidence of neoplastic cells

Exclusion Criteria:

• Scheduled for or use of intravesical therapy (eg, bladder distention, dimethyl sulfoxide) during or within 4 weeks prior to the study

• patients who have had cytoscopic evaluation within 4 weeks prior to the study

• patients who are currently (within last month) receiving other medications that may affect symptoms of interstitial cystitis (ie, antidepressants, antihistamines, antispasmodics, anticholinergics)

• patients who are chronic users of Schedule II narcotics or who are using any scheduled narcotics at the time of study entry

• patients taking coumadin, anticoagulants, heparin, or thrombolytic agents such as tissue plasminogen activator and streptokinase

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Birmingham	Alabama	United States
2		Homewood	Alabama	United States
3		Anchorage	Alaska	United States
4		San Bernardino	California	United States
5		San Carlos	California	United States
6		San Diego	California	United States
7		Torrance	California	United States
8		Denver	Colorado	United States
9		Longmont	Colorado	United States
10		Wheat Ridge	Colorado	United States
11		Newington	Connecticut	United States
12		Norwalk	Connecticut	United States
13		Celebration	Florida	United States
14		Longwood	Florida	United States
15		Plantation	Florida	United States
16		Tampa	Florida	United States
17		Trinity	Florida	United States
18		Venice	Florida	United States
19		Weston	Florida	United States
20		Atlanta	Georgia	United States
21		Centralia	Illinois	United States
22		Evanston	Illinois	United States
23		Peoria	Illinois	United States
24		Jeffersonville	Indiana	United States
25		Dearborn	Michigan	United States
26		Grand Rapids	Michigan	United States
27		Kalamazoo	Michigan	United States
28		Saint Louis	Missouri	United States
29		Henderson	Nevada	United States
30		West Orange	New Jersey	United States
31		Albany	New York	United States
32		Charlotte	North Carolina	United States
33		Concord	North Carolina	United States
34		Winston Salem	North Carolina	United States
35		Lima	Ohio	United States
36		Ponca City	Oklahoma	United States
37		Tulsa	Oklahoma	United States
38		Medford	Oregon	United States
39		Portland	Oregon	United States
40		Philadelphia	Pennsylvania	United States
41		Nashville	Tennessee	United States
42		Arlington	Texas	United States
43		Austin	Texas	United States
44		Carrollton	Texas	United States
45		Fort Worth	Texas	United States
46		San Antonio	Texas	United States
47		Ogden	Utah	United States
48		Salt Lake City	Utah	United States
49		Richmond	Virginia	United States
50		Mountlake Terrace	Washington	United States
51		Seattle	Washington	United States
52		Milwaukee	Wisconsin	United States
53		Edmonton	Alberta	Canada
54		Kelowna	British Columbia	Canada
55		Surrey	British Columbia	Canada
56		Victoria	British Columbia	Canada
57		Fredericton	New Brunswick	Canada
58		Halifax	Nova Scotia	Canada
59		Kentville	Nova Scotia	Canada
60		Barrie	Ontario	Canada
61		Burlington	Ontario	Canada
62		Kingston	Ontario	Canada
63		Kitchener	Ontario	Canada
64		Newmarket	Ontario	Canada
65		Toronto	Ontario	Canada

Sponsors and Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Investigators

• Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• ClinicalTrials.gov Identifier: NCT00086684
• Other Study ID Numbers: CR004576; C-2002-036; NCT00399139
• First Posted: Jul 9, 2004
• Last Update Posted: Apr 21, 2014
• Last Verified: Apr 1, 2014

• Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: Interstitial Cystitis; Urinary Bladder Pain
• Additional relevant MeSH terms: Cystitis; Cystitis, Interstitial; Pentosan Sulfuric Polyester

Study Results

Participant Flow

Pre-assignment Detail	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.

Arm/Group Title	PLACEBO	Pentosan Polysulfate Sodium (ELMIRON) 100MG QD	Pentosan Polysulfate Sodium (ELMIRON) 100MG TID
Arm/Group Description	One 100 mg pentosan polysulfate sodium capsule QD (once daily)	One 100 mg pentosan polysulfate sodium capsule TID (three times a day)
Period Title: Overall Study
STARTED	118	129	122
COMPLETED	63	74	69
NOT COMPLETED	55	55	53

Baseline Characteristics

Arm/Group Title	PLACEBO	Pentosan Polysulfate Sodium (ELMIRON) 100MG QD	Pentosan Polysulfate Sodium (ELMIRON) 100MG TID	Total
Arm/Group Description	One 100 mg pentosan polysulfate sodium capsule QD (once daily)	One 100 mg pentosan polysulfate sodium capsule TID (three times a day)	Total of all reporting groups
Overall Participants	118	129	122	369
Age (Count of Participants)
<=18 years	1 0.8%	1 0.8%	0 0%	2 0.5%
Between 18 and 65 years	103 87.3%	108 83.7%	109 89.3%	320 86.7%
>=65 years	14 11.9%	20 15.5%	13 10.7%	47 12.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	44.6 (14.58)	45.6 (15.68)	42.7 (15.71)	44.3 (15.35)
Sex: Female, Male (Count of Participants)
Female	101 85.6%	119 92.2%	113 92.6%	333 90.2%
Male	17 14.4%	10 7.8%	9 7.4%	36 9.8%
AgeCategorical (participants) [Number]
<18 YEARS	0 0%	0 0%	0 0%	0 0%
18-<64 YEARS	104 88.1%	109 84.5%	109 89.3%	322 87.3%
65-<74 YEARS	10 8.5%	17 13.2%	11 9%	38 10.3%
>=75 YEARS	4 3.4%	3 2.3%	2 1.6%	9 2.4%
Baseline BMI (kg/cm2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/cm2]	27 (6.50)	26.8 (9.42)	27.1 (11.02)	26.9 (9.18)

Outcome Measures

1. Primary Outcome

Title	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
Description	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.
Time Frame	Baseline to Week 24

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) Analysis set

Arm/Group Title	PLACEBO	Pentosan Polysulfate Sodium (ELMIRON) 100MG QD	Pentosan Polysulfate Sodium (ELMIRON) 100MG TID
Arm/Group Description	One 100 mg pentosan polysulfate sodium capsule QD (once daily)	One 100 mg pentosan polysulfate sodium capsule TID (three times a day)
Measure Participants	118	128	122
Number [participants]	48 40.7%	51 39.5%	52 42.6%

2. Secondary Outcome

Title	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
Description	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.
Time Frame	Baseline to Week 24

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) Analysis set

Arm/Group Title	PLACEBO	Pentosan Polysulfate Sodium (ELMIRON) 100MG QD	Pentosan Polysulfate Sodium (ELMIRON) 100MG TID
Arm/Group Description	One 100 mg pentosan polysulfate sodium capsule QD (once daily)	One 100 mg pentosan polysulfate sodium capsule TID (three times a day)
Measure Participants	118	128	122
Number [participants]	55 46.6%	55 42.6%	60 49.2%

Adverse Events

Arm/Group Title	PLACEBO		Pentosan Polysulfate Sodium (ELMIRON) 100MG QD		Pentosan Polysulfate Sodium (ELMIRON) 100MG TID
Arm/Group Description	One 100 mg pentosan polysulfate sodium capsule QD (once daily)		One 100 mg pentosan polysulfate sodium capsule TID (three times a day)
All Cause Mortality
	PLACEBO		Pentosan Polysulfate Sodium (ELMIRON) 100MG QD		Pentosan Polysulfate Sodium (ELMIRON) 100MG TID
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	PLACEBO		Pentosan Polysulfate Sodium (ELMIRON) 100MG QD		Pentosan Polysulfate Sodium (ELMIRON) 100MG TID
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/118 (3.4%)		4/128 (3.1%)		0/122 (0%)
Gastrointestinal disorders
Abdominal Pain	0/118 (0%)		1/128 (0.8%)		0/122 (0%)
Gastrooesophageal Reflux Disease	0/118 (0%)		1/128 (0.8%)		0/122 (0%)
General disorders
Chest Pain	0/118 (0%)		1/128 (0.8%)		0/122 (0%)
Pyrexia	0/118 (0%)		1/128 (0.8%)		0/122 (0%)
Hepatobiliary disorders
Cholelithiasis	1/118 (0.8%)		0/128 (0%)		0/122 (0%)
Gallbladder Cholesterolosis	1/118 (0.8%)		0/128 (0%)		0/122 (0%)
Infections and infestations
Urinary Tract Infection	0/118 (0%)		1/128 (0.8%)		0/122 (0%)
Psychiatric disorders
Anxiety	0/118 (0%)		1/128 (0.8%)		0/122 (0%)
Depression	1/118 (0.8%)		0/128 (0%)		0/122 (0%)
Homicidal Ideation	1/118 (0.8%)		0/128 (0%)		0/122 (0%)
Renal and urinary disorders
Renal Mass	0/118 (0%)		1/128 (0.8%)		0/122 (0%)
Urinary Retention	1/118 (0.8%)		0/128 (0%)		0/122 (0%)
Other (Not Including Serious) Adverse Events
	PLACEBO		Pentosan Polysulfate Sodium (ELMIRON) 100MG QD		Pentosan Polysulfate Sodium (ELMIRON) 100MG TID
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	95/118 (80.5%)		107/128 (83.6%)		97/122 (79.5%)
Blood and lymphatic system disorders
Anaemia	0/118 (0%)		1/128 (0.8%)		0/122 (0%)
Lymphadenopathy	1/118 (0.8%)		1/128 (0.8%)		1/122 (0.8%)
Congenital, familial and genetic disorders
Stargardt's Disease	1/118 (0.8%)		0/128 (0%)		0/122 (0%)
Ear and labyrinth disorders
Deafness Unilateral	0/118 (0%)		1/128 (0.8%)		0/122 (0%)
Ear Pain	0/118 (0%)		1/128 (0.8%)		0/122 (0%)
Motion Sickness	0/118 (0%)		1/128 (0.8%)		0/122 (0%)
Tinnitus	0/118 (0%)		1/128 (0.8%)		0/122 (0%)
Vertigo	0/118 (0%)		2/128 (1.6%)		0/122 (0%)
Endocrine disorders
Hypothyroidism	0/118 (0%)		1/128 (0.8%)		1/122 (0.8%)
Eye disorders
Conjunctival Hyperaemia	1/118 (0.8%)		0/128 (0%)		0/122 (0%)
Dry Eye	0/118 (0%)		0/128 (0%)		1/122 (0.8%)
Macular Degeneration	0/118 (0%)		1/128 (0.8%)		0/122 (0%)
Vision Blurred	1/118 (0.8%)		1/128 (0.8%)		2/122 (1.6%)
Visual Acuity Reduced	0/118 (0%)		1/128 (0.8%)		0/122 (0%)
Gastrointestinal disorders
Abdominal Discomfort	2/118 (1.7%)		3/128 (2.3%)		2/122 (1.6%)
Abdominal Distension	1/118 (0.8%)		2/128 (1.6%)		0/122 (0%)
Abdominal Pain	4/118 (3.4%)		3/128 (2.3%)		3/122 (2.5%)
Abdominal Pain Lower	1/118 (0.8%)		1/128 (0.8%)		0/122 (0%)
Abdominal Pain Upper	0/118 (0%)		2/128 (1.6%)		3/122 (2.5%)
Abdominal Tenderness	1/118 (0.8%)		0/128 (0%)		0/122 (0%)
Ascites	0/118 (0%)		0/128 (0%)		1/122 (0.8%)
Constipation	2/118 (1.7%)		3/128 (2.3%)		0/122 (0%)
Dental Caries	0/118 (0%)		2/128 (1.6%)		0/122 (0%)
Diarrhoea	7/118 (5.9%)		13/128 (10.2%)		6/122 (4.9%)
Dry Mouth	1/118 (0.8%)		1/128 (0.8%)		1/122 (0.8%)
Dyspepsia	2/118 (1.7%)		2/128 (1.6%)		4/122 (3.3%)
Faeces Discoloured	1/118 (0.8%)		0/128 (0%)		0/122 (0%)
Flatulence	2/118 (1.7%)		0/128 (0%)		0/122 (0%)
Food Poisoning	0/118 (0%)		2/128 (1.6%)		0/122 (0%)
Frequent Bowel Movements	0/118 (0%)		1/128 (0.8%)		0/122 (0%)
Gastrointestinal Pain	0/118 (0%)		0/128 (0%)		1/122 (0.8%)
Gastrooesophageal Reflux Disease	0/118 (0%)		1/128 (0.8%)		0/122 (0%)
Haematochezia	0/118 (0%)		1/128 (0.8%)		0/122 (0%)
Haemorrhoids	1/118 (0.8%)		0/128 (0%)		1/122 (0.8%)
Inguinal Hernia	0/118 (0%)		0/128 (0%)		1/122 (0.8%)
Irritable Bowel Syndrome	0/118 (0%)		0/128 (0%)		1/122 (0.8%)
Nausea	9/118 (7.6%)		19/128 (14.8%)		12/122 (9.8%)
Oral Pain	0/118 (0%)		0/128 (0%)		1/122 (0.8%)
Tooth Impacted	0/118 (0%)		0/128 (0%)		1/122 (0.8%)
Toothache	3/118 (2.5%)		1/128 (0.8%)		1/122 (0.8%)
Vomiting	3/118 (2.5%)		10/128 (7.8%)		4/122 (3.3%)
General disorders
Asthenia	0/118 (0%)		2/128 (1.6%)		0/122 (0%)
Chest Discomfort	0/118 (0%)		0/128 (0%)		1/122 (0.8%)
Chest Pain	1/118 (0.8%)		0/128 (0%)		0/122 (0%)
Chills	0/118 (0%)		0/128 (0%)		1/122 (0.8%)
Fatigue	2/118 (1.7%)		1/128 (0.8%)		2/122 (1.6%)
Malaise	1/118 (0.8%)		0/128 (0%)		0/122 (0%)
Oedema Peripheral	1/118 (0.8%)		1/128 (0.8%)		2/122 (1.6%)
Pain	2/118 (1.7%)		1/128 (0.8%)		0/122 (0%)
Pyrexia	1/118 (0.8%)		0/128 (0%)		0/122 (0%)
Suprapubic Pain	0/118 (0%)		1/128 (0.8%)		0/122 (0%)
Tenderness	1/118 (0.8%)		0/128 (0%)		0/122 (0%)
Thirst	1/118 (0.8%)		0/128 (0%)		0/122 (0%)
Hepatobiliary disorders
Cholelithiasis	1/118 (0.8%)		0/128 (0%)		0/122 (0%)
Immune system disorders
Hypersensitivity	1/118 (0.8%)		1/128 (0.8%)		0/122 (0%)
Seasonal Allergy	2/118 (1.7%)		0/128 (0%)		0/122 (0%)
Infections and infestations
Diverticulitis	0/118 (0%)		1/128 (0.8%)		0/122 (0%)
Ear Infection	2/118 (1.7%)		2/128 (1.6%)		1/122 (0.8%)
Eye Infection	0/118 (0%)		2/128 (1.6%)		0/122 (0%)
Fungal Infection	1/118 (0.8%)		2/128 (1.6%)		0/122 (0%)
Gastroenteritis	0/118 (0%)		2/128 (1.6%)		1/122 (0.8%)
Gastroenteritis Viral	2/118 (1.7%)		1/128 (0.8%)		0/122 (0%)
Gingival Infection	0/118 (0%)		1/128 (0.8%)		0/122 (0%)
Herpes Zoster	0/118 (0%)		0/128 (0%)		3/122 (2.5%)
Localised Infection	1/118 (0.8%)		0/128 (0%)		0/122 (0%)
Oral Herpes	0/118 (0%)		0/128 (0%)		1/122 (0.8%)
Otitis Externa	1/118 (0.8%)		0/128 (0%)		0/122 (0%)
Pharyngitis	0/118 (0%)		2/128 (1.6%)		0/122 (0%)
Pharyngitis Streptococcal	2/118 (1.7%)		4/128 (3.1%)		1/122 (0.8%)
Purulent Discharge	1/118 (0.8%)		0/128 (0%)		0/122 (0%)
Pyelonephritis	1/118 (0.8%)		0/128 (0%)		0/122 (0%)
Tonsillitis	0/118 (0%)		1/128 (0.8%)		2/122 (1.6%)
Tooth Abscess	0/118 (0%)		0/128 (0%)		3/122 (2.5%)
Tooth Infection	0/118 (0%)		1/128 (0.8%)		1/122 (0.8%)
Urinary Tract Infection	4/118 (3.4%)		9/128 (7%)		8/122 (6.6%)
Vaginitis Bacterial	0/118 (0%)		0/128 (0%)		1/122 (0.8%)
Viral Infection	1/118 (0.8%)		0/128 (0%)		0/122 (0%)
Vulvovaginal Mycotic Infection	0/118 (0%)		1/128 (0.8%)		3/122 (2.5%)
Injury, poisoning and procedural complications
Animal Bite	1/118 (0.8%)		0/128 (0%)		0/122 (0%)
Contusion	1/118 (0.8%)		1/128 (0.8%)		1/122 (0.8%)
Excoriation	0/118 (0%)		0/128 (0%)		2/122 (1.6%)
Head Injury	0/118 (0%)		1/128 (0.8%)		0/122 (0%)
Joint Sprain	0/118 (0%)		1/128 (0.8%)		0/122 (0%)
Laceration	1/118 (0.8%)		0/128 (0%)		1/122 (0.8%)
Muscle Strain	1/118 (0.8%)		1/128 (0.8%)		1/122 (0.8%)
Tendon Injury	1/118 (0.8%)		0/128 (0%)		0/122 (0%)
Thermal Burn	0/118 (0%)		0/128 (0%)		1/122 (0.8%)
Investigations
Blood Cholesterol Increased	1/118 (0.8%)		0/128 (0%)		0/122 (0%)
Blood Pressure Increased	2/118 (1.7%)		2/128 (1.6%)		0/122 (0%)
Blood Pressure Systolic Increased	0/118 (0%)		0/128 (0%)		1/122 (0.8%)
Blood Urine Present	0/118 (0%)		1/128 (0.8%)		0/122 (0%)
Cardiac Murmur	1/118 (0.8%)		0/128 (0%)		0/122 (0%)
Hepatic Enzyme Increased	1/118 (0.8%)		0/128 (0%)		0/122 (0%)
Monocyte Count Increased	0/118 (0%)		0/128 (0%)		1/122 (0.8%)
Prothrombin Time Prolonged	0/118 (0%)		0/128 (0%)		1/122 (0.8%)
Smear Cervix Abnormal	1/118 (0.8%)		0/128 (0%)		0/122 (0%)
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus	0/118 (0%)		1/128 (0.8%)		0/122 (0%)
Vitamin B12 Deficiency	0/118 (0%)		0/128 (0%)		1/122 (0.8%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/118 (0.8%)		6/128 (4.7%)		0/122 (0%)
Arthritis	0/118 (0%)		1/128 (0.8%)		1/122 (0.8%)
Back Pain	2/118 (1.7%)		7/128 (5.5%)		5/122 (4.1%)
Bunion	1/118 (0.8%)		0/128 (0%)		0/122 (0%)
Fibromyalgia	0/118 (0%)		0/128 (0%)		1/122 (0.8%)
Flank Pain	0/118 (0%)		3/128 (2.3%)		1/122 (0.8%)
Muscle Spasms	0/118 (0%)		2/128 (1.6%)		2/122 (1.6%)
Musculoskeletal Pain	2/118 (1.7%)		3/128 (2.3%)		1/122 (0.8%)
Myalgia	0/118 (0%)		1/128 (0.8%)		0/122 (0%)
Neck Pain	2/118 (1.7%)		0/128 (0%)		0/122 (0%)
Pain in Extremity	5/118 (4.2%)		2/128 (1.6%)		1/122 (0.8%)
Pain in Jaw	1/118 (0.8%)		0/128 (0%)		0/122 (0%)
Tendonitis	1/118 (0.8%)		1/128 (0.8%)		1/122 (0.8%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma	1/118 (0.8%)		0/128 (0%)		0/122 (0%)
Mycosis Fungoides	0/118 (0%)		1/128 (0.8%)		0/122 (0%)
Uterine Leiomyoma	1/118 (0.8%)		0/128 (0%)		0/122 (0%)
Nervous system disorders
Ataxia	1/118 (0.8%)		0/128 (0%)		0/122 (0%)
Carpal Tunnel Syndrome	0/118 (0%)		1/128 (0.8%)		0/122 (0%)
Dizziness	3/118 (2.5%)		2/128 (1.6%)		8/122 (6.6%)
Headache	16/118 (13.6%)		16/128 (12.5%)		14/122 (11.5%)
Hyperaesthesia	0/118 (0%)		1/128 (0.8%)		0/122 (0%)
Hypoaesthesia	1/118 (0.8%)		0/128 (0%)		0/122 (0%)
Insomnia	0/118 (0%)		2/128 (1.6%)		5/122 (4.1%)
Lethargy	0/118 (0%)		1/128 (0.8%)		1/122 (0.8%)
Migraine	2/118 (1.7%)		2/128 (1.6%)		1/122 (0.8%)
Migraine with Aura	0/118 (0%)		1/128 (0.8%)		0/122 (0%)
Presyncope	0/118 (0%)		1/128 (0.8%)		0/122 (0%)
Restless Legs Syndrome	1/118 (0.8%)		0/128 (0%)		0/122 (0%)
Sinus Headache	0/118 (0%)		1/128 (0.8%)		0/122 (0%)
Somnolence	1/118 (0.8%)		0/128 (0%)		0/122 (0%)
Syncope	0/118 (0%)		0/128 (0%)		1/122 (0.8%)
Psychiatric disorders
Anxiety	1/118 (0.8%)		1/128 (0.8%)		1/122 (0.8%)
Depression	1/118 (0.8%)		0/128 (0%)		1/122 (0.8%)
Libido Decreased	1/118 (0.8%)		1/128 (0.8%)		0/122 (0%)
Mood Swings	0/118 (0%)		0/128 (0%)		1/122 (0.8%)
Nightmare	0/118 (0%)		0/128 (0%)		1/122 (0.8%)
Renal and urinary disorders
Bladder Discomfort	0/118 (0%)		1/128 (0.8%)		0/122 (0%)
Bladder Pain	38/118 (32.2%)		35/128 (27.3%)		47/122 (38.5%)
Bladder Prolapse	0/118 (0%)		0/128 (0%)		1/122 (0.8%)
Cystitis	1/118 (0.8%)		1/128 (0.8%)		1/122 (0.8%)
Cystitis Interstitial	11/118 (9.3%)		19/128 (14.8%)		9/122 (7.4%)
Dysuria	2/118 (1.7%)		2/128 (1.6%)		3/122 (2.5%)
Haematuria	1/118 (0.8%)		2/128 (1.6%)		0/122 (0%)
Micturition Urgency	1/118 (0.8%)		1/128 (0.8%)		0/122 (0%)
Nocturia	0/118 (0%)		0/128 (0%)		1/122 (0.8%)
Pollakiuria	0/118 (0%)		1/128 (0.8%)		0/122 (0%)
Urethral Pain	1/118 (0.8%)		0/128 (0%)		0/122 (0%)
Urethral Ulcer	0/118 (0%)		1/128 (0.8%)		0/122 (0%)
Reproductive system and breast disorders
Atrophic Vulvovaginitis	0/118 (0%)		1/128 (0.8%)		1/122 (0.8%)
Cervical Dysplasia	0/118 (0%)		0/128 (0%)		1/122 (0.8%)
Cystocele	0/118 (0%)		0/128 (0%)		1/122 (0.8%)
Dysmenorrhoea	0/118 (0%)		3/128 (2.3%)		2/122 (1.6%)
Menorrhagia	0/118 (0%)		0/128 (0%)		1/122 (0.8%)
Menstrual Disorder	0/118 (0%)		0/128 (0%)		1/122 (0.8%)
Menstruation Irregular	0/118 (0%)		0/128 (0%)		1/122 (0.8%)
Spermatocele	1/118 (0.8%)		0/128 (0%)		0/122 (0%)
Testicular Pain	1/118 (0.8%)		0/128 (0%)		0/122 (0%)
Vaginal Haemorrhage	1/118 (0.8%)		1/128 (0.8%)		0/122 (0%)
Vaginal Odour	1/118 (0.8%)		0/128 (0%)		0/122 (0%)
Vulvovaginal Burning Sensation	0/118 (0%)		1/128 (0.8%)		0/122 (0%)
Vulvovaginal Discomfort	1/118 (0.8%)		0/128 (0%)		0/122 (0%)
Vulvovaginal Pain	0/118 (0%)		0/128 (0%)		1/122 (0.8%)
Vulvovaginal Pruritus	1/118 (0.8%)		0/128 (0%)		1/122 (0.8%)
Respiratory, thoracic and mediastinal disorders
Bronchitis	3/118 (2.5%)		2/128 (1.6%)		1/122 (0.8%)
Cough	0/118 (0%)		2/128 (1.6%)		2/122 (1.6%)
Dyspnoea	0/118 (0%)		1/128 (0.8%)		1/122 (0.8%)
Epistaxis	1/118 (0.8%)		0/128 (0%)		2/122 (1.6%)
Influenza	6/118 (5.1%)		4/128 (3.1%)		3/122 (2.5%)
Lower Respiratory Tract Infection	2/118 (1.7%)		3/128 (2.3%)		1/122 (0.8%)
Nasal Congestion	1/118 (0.8%)		2/128 (1.6%)		1/122 (0.8%)
Nasopharyngitis	2/118 (1.7%)		14/128 (10.9%)		7/122 (5.7%)
Oropharyngeal Pain	1/118 (0.8%)		2/128 (1.6%)		2/122 (1.6%)
Pharyngeal Erythema	1/118 (0.8%)		0/128 (0%)		0/122 (0%)
Pneumonia	0/118 (0%)		0/128 (0%)		1/122 (0.8%)
Rhinorrhoea	2/118 (1.7%)		0/128 (0%)		0/122 (0%)
Sinus Congestion	0/118 (0%)		1/128 (0.8%)		1/122 (0.8%)
Sinusitis	7/118 (5.9%)		7/128 (5.5%)		5/122 (4.1%)
Upper Respiratory Tract Congestion	1/118 (0.8%)		0/128 (0%)		0/122 (0%)
Upper Respiratory Tract Infection	1/118 (0.8%)		3/128 (2.3%)		3/122 (2.5%)
Skin and subcutaneous tissue disorders
Acne	1/118 (0.8%)		0/128 (0%)		0/122 (0%)
Alopecia	1/118 (0.8%)		3/128 (2.3%)		4/122 (3.3%)
Dermatitis Contact	1/118 (0.8%)		0/128 (0%)		0/122 (0%)
Dry Skin	0/118 (0%)		0/128 (0%)		2/122 (1.6%)
Ecchymosis	1/118 (0.8%)		1/128 (0.8%)		1/122 (0.8%)
Hair Texture Abnormal	0/118 (0%)		1/128 (0.8%)		0/122 (0%)
Heat Rash	0/118 (0%)		1/128 (0.8%)		0/122 (0%)
Hyperhidrosis	1/118 (0.8%)		2/128 (1.6%)		0/122 (0%)
Idiopathic Urticaria	0/118 (0%)		0/128 (0%)		1/122 (0.8%)
Night Sweats	1/118 (0.8%)		0/128 (0%)		0/122 (0%)
Pruritus	1/118 (0.8%)		2/128 (1.6%)		1/122 (0.8%)
Rash	2/118 (1.7%)		1/128 (0.8%)		3/122 (2.5%)
Rosacea	1/118 (0.8%)		0/128 (0%)		0/122 (0%)
Urticaria	0/118 (0%)		1/128 (0.8%)		0/122 (0%)
Vascular disorders
Aortic Aneurysm	0/118 (0%)		1/128 (0.8%)		0/122 (0%)
Hot Flush	0/118 (0%)		2/128 (1.6%)		0/122 (0%)
Hypertension	1/118 (0.8%)		0/128 (0%)		2/122 (1.6%)
Hypotension	1/118 (0.8%)		0/128 (0%)		2/122 (1.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT 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.