Trial Outcomes & Findings for Coloplast DialogueStudy (NCT NCT00626821)
NCT ID: NCT00626821
Last Updated: 2012-03-12
Results Overview
The mean change in quality of life (Stoma-QoL value) from visit 1 to visit 2. An increase in Stoma-QoL is an improvement, a decrease in Stoma-QoL is a worsening.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
3017 participants
Primary outcome timeframe
6-8 weeks
Results posted on
2012-03-12
Participant Flow
Participant milestones
| Measure |
SenSura
Test of SenSura for 6-8 weeks
|
|---|---|
|
Overall Study
STARTED
|
3017
|
|
Overall Study
Quality of Life
|
2672
|
|
Overall Study
COMPLETED
|
2796
|
|
Overall Study
NOT COMPLETED
|
221
|
Reasons for withdrawal
| Measure |
SenSura
Test of SenSura for 6-8 weeks
|
|---|---|
|
Overall Study
Adverse Event
|
44
|
|
Overall Study
Protocol Violation
|
33
|
|
Overall Study
Withdrawal by Subject
|
10
|
|
Overall Study
Physician Decision
|
9
|
|
Overall Study
Product dysfunction
|
21
|
|
Overall Study
other/unknown reason
|
104
|
Baseline Characteristics
Coloplast DialogueStudy
Baseline characteristics by cohort
| Measure |
SenSura
n=3017 Participants
Test of SenSura for 6-8 weeks
|
|---|---|
|
Age Continuous
|
63.2 years
STANDARD_DEVIATION 14.3 • n=5 Participants
|
|
Gender
Female
|
1541 participants
n=5 Participants
|
|
Gender
Male
|
1474 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6-8 weeksPopulation: ITT
The mean change in quality of life (Stoma-QoL value) from visit 1 to visit 2. An increase in Stoma-QoL is an improvement, a decrease in Stoma-QoL is a worsening.
Outcome measures
| Measure |
SenSura
n=2672 Participants
Participants tested SenSura for 6-8 weeks. Baseline data were informations about pre-study product.
|
|---|---|
|
Quality of Life (Scale 0(Worst)-100(Best))
|
1.8 units on a scale
Standard Deviation 6.9
|
Adverse Events
SenSura
Serious events: 17 serious events
Other events: 58 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SenSura
n=3017 participants at risk
Test of SenSura for 6-8 weeks
|
|---|---|
|
Surgical and medical procedures
Fistula surgery
|
0.03%
1/3017 • Number of events 1
|
|
Infections and infestations
Scar infection
|
0.03%
1/3017 • Number of events 1
|
|
General disorders
|
0.03%
1/3017 • Number of events 1
|
|
Gastrointestinal disorders
Short bowel syndrome
|
0.03%
1/3017 • Number of events 1
|
|
Gastrointestinal disorders
Bowel obstruction
|
0.03%
1/3017 • Number of events 1
|
|
Surgical and medical procedures
Surgery for ruptured disc
|
0.03%
1/3017 • Number of events 1
|
|
Gastrointestinal disorders
Food blokage in the bowel
|
0.03%
1/3017 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
0.17%
5/3017 • Number of events 5
|
|
Injury, poisoning and procedural complications
Bowel perforation
|
0.03%
1/3017 • Number of events 1
|
|
Surgical and medical procedures
Placement of nephrostomal cathether
|
0.03%
1/3017 • Number of events 1
|
|
General disorders
Exhaustion
|
0.03%
1/3017 • Number of events 1
|
|
Nervous system disorders
Apoplexia
|
0.03%
1/3017 • Number of events 1
|
|
Cardiac disorders
Cardio respiratory arrest
|
0.03%
1/3017 • Number of events 1
|
Other adverse events
| Measure |
SenSura
n=3017 participants at risk
Test of SenSura for 6-8 weeks
|
|---|---|
|
Skin and subcutaneous tissue disorders
Peristomal skin disorder
|
1.7%
52/3017 • Number of events 52
|
|
Gastrointestinal disorders
Gastrointeritis
|
0.07%
2/3017 • Number of events 2
|
|
General disorders
|
0.07%
2/3017 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain
|
0.03%
1/3017 • Number of events 1
|
|
Immune system disorders
Allergic reaction
|
0.03%
1/3017 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60