Trial Outcomes & Findings for Influence of Hyaluronic Acid on Bacillus Calmette-Guérin Local Side Effects (NCT NCT02207608)
NCT ID: NCT02207608
Last Updated: 2015-05-28
Results Overview
1 to 10 scale (1 minimum pain perceivable; 10 unbearable pain, as perceived by the patient)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Before and after six weeks of treatment (end of induction course)
Results posted on
2015-05-28
Participant Flow
Participant milestones
| Measure |
BCG Alone (Immucist®)
Group A receive BCG (Immucist® 81 mg, Sanofi-Aventis Group) alone
BCG (Immucist®)
|
Hyaluronic Acid
Group B receive BCG and HA 40 mg (Cystistat, Mylan, Pittsburgh, PA, U.S.A.).
Hyaluronic Acid
BCG (Immucist®)
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
14
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
BCG Alone (Immucist®)
Group A receive BCG (Immucist® 81 mg, Sanofi-Aventis Group) alone
BCG (Immucist®)
|
Hyaluronic Acid
Group B receive BCG and HA 40 mg (Cystistat, Mylan, Pittsburgh, PA, U.S.A.).
Hyaluronic Acid
BCG (Immucist®)
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Influence of Hyaluronic Acid on Bacillus Calmette-Guérin Local Side Effects
Baseline characteristics by cohort
| Measure |
BCG Alone (Immucist®)
n=14 Participants
Group A receive BCG (Immucist® 81 mg, Sanofi-Aventis Group) alone
BCG (Immucist®)
|
Hyaluronic Acid
n=15 Participants
Group B receive BCG and HA 40 mg (Cystistat, Mylan, Pittsburgh, PA, U.S.A.).
Hyaluronic Acid
BCG (Immucist®)
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66 years
n=99 Participants
|
68 years
n=107 Participants
|
67 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Italy
|
14 participants
n=99 Participants
|
15 participants
n=107 Participants
|
29 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Before and after six weeks of treatment (end of induction course)1 to 10 scale (1 minimum pain perceivable; 10 unbearable pain, as perceived by the patient)
Outcome measures
| Measure |
BCG Alone (Immucist®)
n=14 Participants
Group A receive BCG (Immucist® 81 mg, Sanofi-Aventis Group) alone
BCG (Immucist®)
|
Hyaluronic Acid
n=15 Participants
Group B receive BCG and HA 40 mg (Cystistat, Mylan, Pittsburgh, PA, U.S.A.).
Hyaluronic Acid
BCG (Immucist®)
|
|---|---|---|
|
Visual Analogue Scale for Pain
Data Before treatment
|
4.5 units on a scale
Standard Deviation 2
|
4.9 units on a scale
Standard Deviation 1.8
|
|
Visual Analogue Scale for Pain
Data after treatment
|
5.8 units on a scale
Standard Deviation 1
|
4.2 units on a scale
Standard Deviation 1.6
|
Adverse Events
BCG Alone (Immucist®)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Hyaluronic Acid
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BCG Alone (Immucist®)
n=15 participants at risk
Group A receive BCG (Immucist® 81 mg, Sanofi-Aventis Group) alone
BCG (Immucist®)
|
Hyaluronic Acid
n=15 participants at risk
Group B receive BCG and HA 40 mg (Cystistat, Mylan, Pittsburgh, PA, U.S.A.).
Hyaluronic Acid
BCG (Immucist®)
|
|---|---|---|
|
Renal and urinary disorders
Urgency
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
Additional Information
Prof. Enrico Finazzi Agro
University of Rome Tor Vergata
Phone: +393296152920
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place