observed for placebo (p
±
0.9). Five of the 16 subjects
in the placebo group without modeling greatly influ-
enced the results of this placebo group since each
had more than a 40% improvement in penile curva-
ture. Four of these subjects had a PD history of less
than 1 year and the other had a 15-month PD
history.
Questionnaire responses.
Consistent with curva-
ture change results, subjects with modeling had a
statistically significant mean improvement in the
PD symptom bother domain score when those on
CCh were compared to those on placebo (p
±
0.004,
Appendix 2 and
fig. 2
,
B
). In patients without mod-
eling no statistically significant difference was noted
between CCh and placebo. Limited clinically mean-
ingful differences in IIEF questionnaire responses
were observed between the treatment groups with
vs without modeling. However, observations in the
per protocol population indicated that subjects with
modeling had a statistically significant mean im-
provement in the IIEF overall sexual satisfaction
score when CCh treatment was compared to placebo
(p
±
0.04).
-80
-60
-40
-20
0
20
CCH
Placebo
-29.7
-11.0
-32.4
2.5
-27.1 -27.9
Overall*
With modeling** Without modeling
N: 109
36
54
20
55
16
Percent change in
penile curvature
Baseline curvature:
54.4 50.6
54.7
51.9
54.1
48.9
-10
-8
-6
-4
-2
0
CCH
Placebo
With modeling
Without modeling
N:
50
18
50
16
-3.6*
-0.1
-1.5
-1.5
Change in PD Symptom
Bother Score
Baseline PD Bother:
8.6
7.6
7.5
8.7
A
B
Figure 2.
Mean change in penile curvature from baseline to week 36 using last observation carried forward overall, and with and
without modeling.
A
, percent of penile curvature. Single asterisk indicates p
±
0.001 CCh vs placebo. Double asterisks indicate p
²
0.001
CCh vs placebo with modeling.
B
, PD symptom bother scores (maximum 20). Asterisk indicates p
±
0.004 CCh vs placebo/modeling.
Table 3.
Treatment related AEs in 5 or more patients per
treatment group
System Organ Class
Preferred Term
No. CCh (%)
No. Placebo (%)
p Value
Overall
111
36
—
1 or Greater treatment related AEs
107 (96.4)
19 (52.8)
—
Injection site:
Bruising
96 (86.5)
16 (44.4)
²
0.001*
Edema
50 (45.0)
0 (0.0)
²
0.001*
Pain
58 (52.3)
4 (11.1)
²
0.001*
Pruritus
6 (5.4)
0
0.3
Contusion
16 (14.4)
1 (2.8)
0.07
ED
5 (4.5)
0
0.3
Painful erection
5 (4.5)
0
0.3
Penile edema
11 (9.9)
0
0.07
Penile pain
11 (9.9)
0
0.07
* Statistically significantly different (Fisher exact test).
PHASE 2B STUDY OF COLLAGENASE CLOSTRIDIUM HISTOLYTICUM
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