Trial Outcomes & Findings for Diltiazem Hydrochloride Cream for Anal Fissure (NCT NCT01217515)
NCT ID: NCT01217515
Last Updated: 2014-07-17
Results Overview
Change from baseline in average of worst anal pain associated with or following defaecation for Week 4 (for the 7 treatment days immediately preceding the Week 4 visit). Numerical Rating Scale, range 0-10 where 0 = no pain and 10 = worst pain imaginable.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
465 participants
Primary outcome timeframe
4 weeks
Results posted on
2014-07-17
Participant Flow
Out-patient clinics
one week run-in period
Participant milestones
| Measure |
Diltiazem Hydrochloride 2% Cream
2.5 cm of Diltiazem hydrochloride 2% cream applied peri-anally three times daily for eight weeks.
Diltiazem hydrochloride 2% cream : 3 times daily
|
Diltiazem Hydrochloride 4% Cream
2.5 cm Diltiazem hydrochloride 4% cream applied peri-anally three times daily for eight weeks.
Diltiazem hydrochloride 4% cream : 3 times daily
|
Placebo Cream
2.5 cm placebo cream applied peri-anally three times daily for eight weeks.
Placebo : 3 times daily
|
|---|---|---|---|
|
Overall Study
STARTED
|
154
|
156
|
155
|
|
Overall Study
COMPLETED
|
147
|
148
|
145
|
|
Overall Study
NOT COMPLETED
|
7
|
8
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Diltiazem Hydrochloride Cream for Anal Fissure
Baseline characteristics by cohort
| Measure |
Diltiazem Hydrochloride 2% Cream
n=154 Participants
2.5 cm of Diltiazem hydrochloride 2% cream applied peri-anally three times daily for eight weeks.
Diltiazem hydrochloride 2% cream : 3 times daily
|
Diltiazem Hydrochloride 4% Cream
n=156 Participants
2.5 cm Diltiazem hydrochloride 4% cream applied peri-anally three times daily for eight weeks.
Diltiazem hydrochloride 4% cream : 3 times daily
|
Placebo Cream
n=155 Participants
2.5 cm placebo cream applied peri-anally three times daily for eight weeks.
Placebo : 3 times daily
|
Total
n=465 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
145 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
440 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Age, Continuous
|
44.2 years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
42.5 years
STANDARD_DEVIATION 13.6 • n=7 Participants
|
43.2 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
43.3 years
STANDARD_DEVIATION 13.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
80 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
263 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
202 Participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
Region of Enrollment
Romania
|
101 participants
n=5 Participants
|
105 participants
n=7 Participants
|
103 participants
n=5 Participants
|
309 participants
n=4 Participants
|
|
Region of Enrollment
Lithuania
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
17 participants
n=4 Participants
|
|
Region of Enrollment
Bulgaria
|
28 participants
n=5 Participants
|
28 participants
n=7 Participants
|
30 participants
n=5 Participants
|
86 participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
12 participants
n=5 Participants
|
10 participants
n=7 Participants
|
8 participants
n=5 Participants
|
30 participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
4 participants
n=5 Participants
|
14 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 4 weeksChange from baseline in average of worst anal pain associated with or following defaecation for Week 4 (for the 7 treatment days immediately preceding the Week 4 visit). Numerical Rating Scale, range 0-10 where 0 = no pain and 10 = worst pain imaginable.
Outcome measures
| Measure |
Diltiazem Hydrochloride 2% Cream
n=154 Participants
2.5 cm of Diltiazem hydrochloride 2% cream applied peri-anally three times daily for eight weeks.
Diltiazem hydrochloride 2% cream : 3 times daily
|
Diltiazem Hydrochloride 4% Cream
n=156 Participants
2.5 cm Diltiazem hydrochloride 4% cream applied peri-anally three times daily for eight weeks.
Diltiazem hydrochloride 4% cream : 3 times daily
|
Placebo Cream
n=155 Participants
2.5 cm placebo cream applied peri-anally three times daily for eight weeks.
Placebo : 3 times daily
|
|---|---|---|---|
|
Change From Baseline in Average of Worst Anal Pain Associated With or Following Defaecation for Week 4 (for the 7 Treatment Days Immediately Preceding the Week 4 Visit).
|
-2.63 units on a scale
Standard Error 0.15
|
-2.64 units on a scale
Standard Error 0.15
|
-2.20 units on a scale
Standard Error 0.15
|
SECONDARY outcome
Timeframe: 4 weeksCompared to the way you felt prior to starting the study treatment, how would you now describe your problems related to the anal fissure?" Responses will be measured on a 7-point Likert scale where 1 = substantially worse, 2 = moderately worse, 3 = slightly worse, 4 = no change, 5 = slightly improved, 6 = moderately improved, and 7 = substantially improved. Percentage of subjects scoring 5,6 or 7 was assessed.
Outcome measures
| Measure |
Diltiazem Hydrochloride 2% Cream
n=154 Participants
2.5 cm of Diltiazem hydrochloride 2% cream applied peri-anally three times daily for eight weeks.
Diltiazem hydrochloride 2% cream : 3 times daily
|
Diltiazem Hydrochloride 4% Cream
n=156 Participants
2.5 cm Diltiazem hydrochloride 4% cream applied peri-anally three times daily for eight weeks.
Diltiazem hydrochloride 4% cream : 3 times daily
|
Placebo Cream
n=155 Participants
2.5 cm placebo cream applied peri-anally three times daily for eight weeks.
Placebo : 3 times daily
|
|---|---|---|---|
|
Patient's Global Impression of Improvement (PGI-I)
|
62.4 percentage of participants
|
51.9 percentage of participants
|
46.5 percentage of participants
|
SECONDARY outcome
Timeframe: 8 weeksNumber of subjects with adverse events, abnormal clinical laboratory results, vital signs and occurrence of any local sensitivity reactions. Data are presented where the incidence is greater than or equal to 5%.
Outcome measures
| Measure |
Diltiazem Hydrochloride 2% Cream
n=154 Participants
2.5 cm of Diltiazem hydrochloride 2% cream applied peri-anally three times daily for eight weeks.
Diltiazem hydrochloride 2% cream : 3 times daily
|
Diltiazem Hydrochloride 4% Cream
n=156 Participants
2.5 cm Diltiazem hydrochloride 4% cream applied peri-anally three times daily for eight weeks.
Diltiazem hydrochloride 4% cream : 3 times daily
|
Placebo Cream
n=155 Participants
2.5 cm placebo cream applied peri-anally three times daily for eight weeks.
Placebo : 3 times daily
|
|---|---|---|---|
|
Assessment of Adverse Events, Clinical Laboratory Results, Vital Signs and Sensitivity Reactions
|
70.1 percentage of participants
|
70.5 percentage of participants
|
60.6 percentage of participants
|
Adverse Events
Diltiazem Hydrochloride 2% Cream
Serious events: 0 serious events
Other events: 108 other events
Deaths: 0 deaths
Diltiazem Hydrochloride 4% Cream
Serious events: 1 serious events
Other events: 110 other events
Deaths: 0 deaths
Placebo Cream
Serious events: 0 serious events
Other events: 94 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Diltiazem Hydrochloride 2% Cream
n=154 participants at risk
2.5 cm of Diltiazem hydrochloride 2% cream applied peri-anally three times daily for eight weeks.
Diltiazem hydrochloride 2% cream : 3 times daily
|
Diltiazem Hydrochloride 4% Cream
n=156 participants at risk
2.5 cm Diltiazem hydrochloride 4% cream applied peri-anally three times daily for eight weeks.
Diltiazem hydrochloride 4% cream : 3 times daily
|
Placebo Cream
n=155 participants at risk
2.5 cm placebo cream applied peri-anally three times daily for eight weeks.
Placebo : 3 times daily
|
|---|---|---|---|
|
Gastrointestinal disorders
Stapled haemorrhoidopexy
|
0.00%
0/154 • Throughout treatment period.
Adverse events were recorded in the patient diary. For clarity adverse events recorded here are listed by organ system.
|
0.64%
1/156 • Number of events 1 • Throughout treatment period.
Adverse events were recorded in the patient diary. For clarity adverse events recorded here are listed by organ system.
|
0.00%
0/155 • Throughout treatment period.
Adverse events were recorded in the patient diary. For clarity adverse events recorded here are listed by organ system.
|
Other adverse events
| Measure |
Diltiazem Hydrochloride 2% Cream
n=154 participants at risk
2.5 cm of Diltiazem hydrochloride 2% cream applied peri-anally three times daily for eight weeks.
Diltiazem hydrochloride 2% cream : 3 times daily
|
Diltiazem Hydrochloride 4% Cream
n=156 participants at risk
2.5 cm Diltiazem hydrochloride 4% cream applied peri-anally three times daily for eight weeks.
Diltiazem hydrochloride 4% cream : 3 times daily
|
Placebo Cream
n=155 participants at risk
2.5 cm placebo cream applied peri-anally three times daily for eight weeks.
Placebo : 3 times daily
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
59.1%
91/154 • Number of events 260 • Throughout treatment period.
Adverse events were recorded in the patient diary. For clarity adverse events recorded here are listed by organ system.
|
65.4%
102/156 • Number of events 296 • Throughout treatment period.
Adverse events were recorded in the patient diary. For clarity adverse events recorded here are listed by organ system.
|
54.2%
84/155 • Number of events 283 • Throughout treatment period.
Adverse events were recorded in the patient diary. For clarity adverse events recorded here are listed by organ system.
|
|
Nervous system disorders
Nervous system disorders
|
13.0%
20/154 • Number of events 34 • Throughout treatment period.
Adverse events were recorded in the patient diary. For clarity adverse events recorded here are listed by organ system.
|
17.3%
27/156 • Number of events 40 • Throughout treatment period.
Adverse events were recorded in the patient diary. For clarity adverse events recorded here are listed by organ system.
|
14.8%
23/155 • Number of events 47 • Throughout treatment period.
Adverse events were recorded in the patient diary. For clarity adverse events recorded here are listed by organ system.
|
|
Infections and infestations
Infections and infestations
|
7.1%
11/154 • Number of events 12 • Throughout treatment period.
Adverse events were recorded in the patient diary. For clarity adverse events recorded here are listed by organ system.
|
8.3%
13/156 • Number of events 20 • Throughout treatment period.
Adverse events were recorded in the patient diary. For clarity adverse events recorded here are listed by organ system.
|
3.9%
6/155 • Number of events 8 • Throughout treatment period.
Adverse events were recorded in the patient diary. For clarity adverse events recorded here are listed by organ system.
|
|
General disorders
General disorders and administration site conditions
|
3.2%
5/154 • Number of events 6 • Throughout treatment period.
Adverse events were recorded in the patient diary. For clarity adverse events recorded here are listed by organ system.
|
3.8%
6/156 • Number of events 6 • Throughout treatment period.
Adverse events were recorded in the patient diary. For clarity adverse events recorded here are listed by organ system.
|
5.2%
8/155 • Number of events 12 • Throughout treatment period.
Adverse events were recorded in the patient diary. For clarity adverse events recorded here are listed by organ system.
|
Additional Information
Dr C Jordan, Head of Clinical Operations
S.L.A. Pharma UK Ltd
Phone: 44 01923 681001
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60