Trial Outcomes & Findings for Treatment of Diarrhea-predominant Irritable Bowel Syndrome (IBS-D) With LACTEOL® 340 mg (NCT NCT01358708)
NCT ID: NCT01358708
Last Updated: 2017-03-21
Results Overview
Subjects were considered as responders if they had answered "Yes" to the following question at least 50% of the time during the 4-week treatment phase: "Over the past week, do you consider that you have had satisfactory relief from your IBS symptoms?"
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
26 participants
Primary outcome timeframe
Weekly Assessment (every 7 days)
Results posted on
2017-03-21
Participant Flow
First subject in: 22 June 2010; last subject out: 12 September 2011; ten (10) sites were recruited to participate in this trial and 7 of these (4 in France and 3 in Germany) enrolled subjects.
Inclusion criteria related to symptom severity and stool characteristics assessed during 2nd week of Run-In Phase; ≥ 5 days of symptom data necessary for randomization; Double-Blind Phase completers eligible for a 28-day open-label treatment with LACTEOL® if symptoms not improved or recurring within 1 month after end of blinded treatment.
Participant milestones
| Measure |
LACTEOL® 340 mg
LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
|
PLACEBO
Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
|
|---|---|---|
|
Double-Blind Treatment Phase
STARTED
|
13
|
13
|
|
Double-Blind Treatment Phase
Randomized
|
13
|
13
|
|
Double-Blind Treatment Phase
Received Study Medication
|
12
|
13
|
|
Double-Blind Treatment Phase
COMPLETED
|
10
|
13
|
|
Double-Blind Treatment Phase
NOT COMPLETED
|
3
|
0
|
|
Open-Label Treatment Phase
STARTED
|
5
|
12
|
|
Open-Label Treatment Phase
COMPLETED
|
5
|
12
|
|
Open-Label Treatment Phase
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
LACTEOL® 340 mg
LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
|
PLACEBO
Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
|
|---|---|---|
|
Double-Blind Treatment Phase
Lost to Follow-up
|
2
|
0
|
|
Double-Blind Treatment Phase
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Treatment of Diarrhea-predominant Irritable Bowel Syndrome (IBS-D) With LACTEOL® 340 mg
Baseline characteristics by cohort
| Measure |
LACTEOL® 340 mg
n=13 Participants
LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
|
PLACEBO
n=13 Participants
Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
|
Total
n=26 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
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Weekly Assessment (every 7 days)Population: Analysis conducted on the Intent-to-Treat population defined as all randomized subjects; observed case (OC) data with no imputation made
Subjects were considered as responders if they had answered "Yes" to the following question at least 50% of the time during the 4-week treatment phase: "Over the past week, do you consider that you have had satisfactory relief from your IBS symptoms?"
Outcome measures
| Measure |
LACTEOL® 340 mg
n=13 Participants
LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
|
PLACEBO
n=13 Participants
Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
|
LACTEOL® 340 mg Open-Label Period
LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
|
|---|---|---|---|
|
Global Assessment of Relief During the Double-Blind Treatment Phase Using the Subject Global Assessment (SGA)
Responders
|
30.8 percentage of participants
|
30.8 percentage of participants
|
—
|
|
Global Assessment of Relief During the Double-Blind Treatment Phase Using the Subject Global Assessment (SGA)
Non-responders
|
69.2 percentage of participants
|
69.2 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Weekly Assessment (every 7 days)Population: Analysis conducted on the Intent-to-Treat population defined as all subjects randomized to double-blind treatment and who subsequently entered the Open-Label Treatment Phase; observed case (OC) data with no imputation made; SGA data not available for one patient so that the analysis was performed on 16 rather than 17 patients
Subjects were considered as responders if they had answered "Yes" to the following question at least 50% of the time during the 4-week treatment phase: "Over the past week, do you consider that you have had satisfactory relief from your IBS symptoms?"
Outcome measures
| Measure |
LACTEOL® 340 mg
n=16 Participants
LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
|
PLACEBO
Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
|
LACTEOL® 340 mg Open-Label Period
LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
|
|---|---|---|---|
|
Global Assessment of Relief During the Open-Label Treatment Phase Using the Subject Global Assessment (SGA)
Responders
|
50.0 percentage of participants
|
—
|
—
|
|
Global Assessment of Relief During the Open-Label Treatment Phase Using the Subject Global Assessment (SGA)
Non-responders
|
50.0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Weekly assessment (every 7 days)Population: Analysis conducted on the Intent-to-Treat population defined as all randomized subjects; observed case (OC) data with no imputation made. Number of participants analyzed refers to number of participants at Baseline.
The IBS-SSS has five questions related to four domains: abdominal pain severity and duration, abdominal distension, dissatisfaction with bowel habit and quality of life. The IBS-SSS score ranges from 0 (best outcome) to 500 (worst outcome).
Outcome measures
| Measure |
LACTEOL® 340 mg
n=13 Participants
LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
|
PLACEBO
n=13 Participants
Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
|
LACTEOL® 340 mg Open-Label Period
LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
|
|---|---|---|---|
|
Symptom Severity During the Double-Blind Treatment Phase Using the IBS Symptom Severity Scale (IBS-SSS) Total Score
Baseline IBS-SSS score
|
245.0 units on a scale (from 0 to 500)
Standard Deviation 87.3
|
307.5 units on a scale (from 0 to 500)
Standard Deviation 72.36
|
—
|
|
Symptom Severity During the Double-Blind Treatment Phase Using the IBS Symptom Severity Scale (IBS-SSS) Total Score
IBS-SSS score at end of Week 1 (Day 7)
|
219.2 units on a scale (from 0 to 500)
Standard Deviation 76.36
|
271.2 units on a scale (from 0 to 500)
Standard Deviation 109.72
|
—
|
|
Symptom Severity During the Double-Blind Treatment Phase Using the IBS Symptom Severity Scale (IBS-SSS) Total Score
IBS-SSS score at end of Week 2 (Day 14)
|
229.5 units on a scale (from 0 to 500)
Standard Deviation 81.95
|
265.4 units on a scale (from 0 to 500)
Standard Deviation 99.93
|
—
|
|
Symptom Severity During the Double-Blind Treatment Phase Using the IBS Symptom Severity Scale (IBS-SSS) Total Score
IBS-SSS score at end of Week 3 (Day 21)
|
233.6 units on a scale (from 0 to 500)
Standard Deviation 87.78
|
254.8 units on a scale (from 0 to 500)
Standard Deviation 103.75
|
—
|
|
Symptom Severity During the Double-Blind Treatment Phase Using the IBS Symptom Severity Scale (IBS-SSS) Total Score
IBS-SSS score at end of Week 4 (Day 28)
|
228.6 units on a scale (from 0 to 500)
Standard Deviation 91.82
|
241.4 units on a scale (from 0 to 500)
Standard Deviation 99.23
|
—
|
SECONDARY outcome
Timeframe: Daily assessmentPopulation: Analysis conducted on the Intent-to-Treat population defined as all randomized subjects; observed case (OC) data with no imputation made. Number of participants analyzed refers to number of participants at Baseline.
The Bristol Stool Form Scale score ranges from 1 to 7 from hard (score of 1) to watery (score of 7). Data are presented as the mean of daily assessments over a week.
Outcome measures
| Measure |
LACTEOL® 340 mg
n=13 Participants
LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
|
PLACEBO
n=13 Participants
Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
|
LACTEOL® 340 mg Open-Label Period
LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
|
|---|---|---|---|
|
Stool Characteristics During the Double-Blind Treatment Phase Using the Bristol Stool Form Scale
Baseline Bristol Stool Form Scale Score
|
4.8 units on a scale (from 1 ato 7)
Standard Deviation 1.14
|
4.9 units on a scale (from 1 ato 7)
Standard Deviation 0.64
|
—
|
|
Stool Characteristics During the Double-Blind Treatment Phase Using the Bristol Stool Form Scale
Bristol Stool Form Score during Week 1
|
4.3 units on a scale (from 1 ato 7)
Standard Deviation 1.29
|
4.8 units on a scale (from 1 ato 7)
Standard Deviation 0.61
|
—
|
|
Stool Characteristics During the Double-Blind Treatment Phase Using the Bristol Stool Form Scale
Bristol Stool Form Score during Week 2
|
4.6 units on a scale (from 1 ato 7)
Standard Deviation 1.33
|
4.8 units on a scale (from 1 ato 7)
Standard Deviation 0.83
|
—
|
|
Stool Characteristics During the Double-Blind Treatment Phase Using the Bristol Stool Form Scale
Bristol Stool Form Score during Week 3
|
4.4 units on a scale (from 1 ato 7)
Standard Deviation 1.52
|
4.4 units on a scale (from 1 ato 7)
Standard Deviation 0.78
|
—
|
|
Stool Characteristics During the Double-Blind Treatment Phase Using the Bristol Stool Form Scale
Bristol Stool Form Score during Week 4
|
4.4 units on a scale (from 1 ato 7)
Standard Deviation 1.32
|
4.8 units on a scale (from 1 ato 7)
Standard Deviation 0.81
|
—
|
SECONDARY outcome
Timeframe: At Screening and End of Double-Blind Treatment PhasePopulation: Analysis conducted on the Intent-to-Treat population defined as all randomized subjects; observed case (OC) data with no imputation made
The HADS has 14 questions related to 2 domains: Anxiety subscale (7 questions) and Depression subscale (7 questions). Each question is graded from 0 (best outcome) to 3 (worst outcome), for a total score ranging from 0 (best outcome) to 42 (worst outcome).
Outcome measures
| Measure |
LACTEOL® 340 mg
n=13 Participants
LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
|
PLACEBO
n=13 Participants
Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
|
LACTEOL® 340 mg Open-Label Period
LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
|
|---|---|---|---|
|
Hospital Anxiety and Depression Scale (HADS) Score During the Double-Blind Phase
Baseline HADS Total Score
|
9.7 units on a scale (from 0 to 42)
Standard Deviation 5.14
|
10.7 units on a scale (from 0 to 42)
Standard Deviation 4.82
|
—
|
|
Hospital Anxiety and Depression Scale (HADS) Score During the Double-Blind Phase
HADS Total Score at End of Double-Blind Treatment
|
9.9 units on a scale (from 0 to 42)
Standard Deviation 6.10
|
9.5 units on a scale (from 0 to 42)
Standard Deviation 5.88
|
—
|
SECONDARY outcome
Timeframe: Weekly assessment (every 7 days)Population: Analysis conducted on the Intent-to-Treat population defined as all subjects randomized to double-blind treatment and who subsequently entered the Open-Label Treatment Phase; observed case (OC) data with no imputation made; baseline defined as the last non-missing assessment prior to the first dose of double-blind medication.
The IBS-SSS has five questions related to four domains: abdominal pain severity and duration, abdominal distension, dissatisfaction with bowel habit and quality of life. The IBS-SSS score ranges from 0 (best outcome) to 500 (worst outcome).
Outcome measures
| Measure |
LACTEOL® 340 mg
n=17 Participants
LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
|
PLACEBO
Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
|
LACTEOL® 340 mg Open-Label Period
LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
|
|---|---|---|---|
|
Symptom Severity During the Open-Label Treatment Phase Using the IBS Symptom Severity Scale (IBS-SSS) Total Score
Double-Blind Baseline IBS-SSS score
|
270.5 units on a scale (from 0 to 500)
Standard Deviation 78.2
|
—
|
—
|
|
Symptom Severity During the Open-Label Treatment Phase Using the IBS Symptom Severity Scale (IBS-SSS) Total Score
IBS-SSS score at end of Week 1 (Day 7)
|
224.6 units on a scale (from 0 to 500)
Standard Deviation 73.06
|
—
|
—
|
|
Symptom Severity During the Open-Label Treatment Phase Using the IBS Symptom Severity Scale (IBS-SSS) Total Score
IBS-SSS score at end of Week 2 (Day 14)
|
211.5 units on a scale (from 0 to 500)
Standard Deviation 93.58
|
—
|
—
|
|
Symptom Severity During the Open-Label Treatment Phase Using the IBS Symptom Severity Scale (IBS-SSS) Total Score
IBS-SSS score at end of Week 3 (Day 21)
|
199.2 units on a scale (from 0 to 500)
Standard Deviation 103.68
|
—
|
—
|
|
Symptom Severity During the Open-Label Treatment Phase Using the IBS Symptom Severity Scale (IBS-SSS) Total Score
IBS-SSS score at end of Week 4 (Day 28)
|
222.5 units on a scale (from 0 to 500)
Standard Deviation 103.14
|
—
|
—
|
SECONDARY outcome
Timeframe: Daily assessmentPopulation: Analysis conducted on the Intent-to-Treat population defined as all subjects randomized to double-blind treatment and who subsequently entered the Open-Label Treatment Phase ; observed case (OC) data with no imputation made; baseline defined as the last non-missing assessment prior to the first dose of double-blind study medication
The Bristol Stool Form Scale (BSFS) score ranges from 1 to 7 from hard (score of 1) to watery (score of 7). Data are presented as the mean of daily assessments over a week.
Outcome measures
| Measure |
LACTEOL® 340 mg
n=17 Participants
LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
|
PLACEBO
Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
|
LACTEOL® 340 mg Open-Label Period
LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
|
|---|---|---|---|
|
Stool Characteristics During the Open-Label Treatment Phase Using the BSFS
Double-Blind Baseline BSFS Score
|
5.0 units on a scale (from 1 to 7)
Standard Deviation 0.68
|
—
|
—
|
|
Stool Characteristics During the Open-Label Treatment Phase Using the BSFS
BSFS score during Week 1
|
4.6 units on a scale (from 1 to 7)
Standard Deviation 1.10
|
—
|
—
|
|
Stool Characteristics During the Open-Label Treatment Phase Using the BSFS
BSFS score during Week 2
|
4.5 units on a scale (from 1 to 7)
Standard Deviation 1.24
|
—
|
—
|
|
Stool Characteristics During the Open-Label Treatment Phase Using the BSFS
BSFS score during Week 3
|
4.4 units on a scale (from 1 to 7)
Standard Deviation 1.45
|
—
|
—
|
|
Stool Characteristics During the Open-Label Treatment Phase Using the BSFS
BSFS score during Week 4
|
4.4 units on a scale (from 1 to 7)
Standard Deviation 1.33
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Analysis conducted on the Intent-to-Treat population for both treatment phases
Number of subjects using rescue medication (bisacodyl or loperamide) during each treatment phase of the study
Outcome measures
| Measure |
LACTEOL® 340 mg
n=13 Participants
LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
|
PLACEBO
n=13 Participants
Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
|
LACTEOL® 340 mg Open-Label Period
n=17 Participants
LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
|
|---|---|---|---|
|
Use of Rescue Medication During the Double-Blind and Open-Label Treatment Phases of the Study
|
2 participants
|
0 participants
|
0 participants
|
Adverse Events
LACTEOL® 340 mg Double-Blind Period
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
PLACEBO Double-Blind Period
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
LACTEOL® 340 mg Open-Label Period
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LACTEOL® 340 mg Double-Blind Period
n=13 participants at risk
LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
|
PLACEBO Double-Blind Period
n=13 participants at risk
Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
|
LACTEOL® 340 mg Open-Label Period
n=17 participants at risk
LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
|
|---|---|---|---|
|
Infections and infestations
Gastrointestinal infection
|
7.7%
1/13 • Number of events 1 • From Informed Consent Form signature up to 28 days following the end of double-blind treatment (symptom recurrence observation period) or up to End of Open-Label Treatment Phase Visit (Days 29 to 38) for subjects continuing with open-label treatment
Adverse events collected during study visits as well as via an interactive voice response system (IVRS) while at home; clinical labs performed at baseline and end of each period; only treatment-emergent adverse events are displayed, ie. events that occurred or worsened in intensity on or after the first dose of study medication in each period.
|
0.00%
0/13 • From Informed Consent Form signature up to 28 days following the end of double-blind treatment (symptom recurrence observation period) or up to End of Open-Label Treatment Phase Visit (Days 29 to 38) for subjects continuing with open-label treatment
Adverse events collected during study visits as well as via an interactive voice response system (IVRS) while at home; clinical labs performed at baseline and end of each period; only treatment-emergent adverse events are displayed, ie. events that occurred or worsened in intensity on or after the first dose of study medication in each period.
|
0.00%
0/17 • From Informed Consent Form signature up to 28 days following the end of double-blind treatment (symptom recurrence observation period) or up to End of Open-Label Treatment Phase Visit (Days 29 to 38) for subjects continuing with open-label treatment
Adverse events collected during study visits as well as via an interactive voice response system (IVRS) while at home; clinical labs performed at baseline and end of each period; only treatment-emergent adverse events are displayed, ie. events that occurred or worsened in intensity on or after the first dose of study medication in each period.
|
|
Infections and infestations
Influenza
|
0.00%
0/13 • From Informed Consent Form signature up to 28 days following the end of double-blind treatment (symptom recurrence observation period) or up to End of Open-Label Treatment Phase Visit (Days 29 to 38) for subjects continuing with open-label treatment
Adverse events collected during study visits as well as via an interactive voice response system (IVRS) while at home; clinical labs performed at baseline and end of each period; only treatment-emergent adverse events are displayed, ie. events that occurred or worsened in intensity on or after the first dose of study medication in each period.
|
7.7%
1/13 • Number of events 1 • From Informed Consent Form signature up to 28 days following the end of double-blind treatment (symptom recurrence observation period) or up to End of Open-Label Treatment Phase Visit (Days 29 to 38) for subjects continuing with open-label treatment
Adverse events collected during study visits as well as via an interactive voice response system (IVRS) while at home; clinical labs performed at baseline and end of each period; only treatment-emergent adverse events are displayed, ie. events that occurred or worsened in intensity on or after the first dose of study medication in each period.
|
0.00%
0/17 • From Informed Consent Form signature up to 28 days following the end of double-blind treatment (symptom recurrence observation period) or up to End of Open-Label Treatment Phase Visit (Days 29 to 38) for subjects continuing with open-label treatment
Adverse events collected during study visits as well as via an interactive voice response system (IVRS) while at home; clinical labs performed at baseline and end of each period; only treatment-emergent adverse events are displayed, ie. events that occurred or worsened in intensity on or after the first dose of study medication in each period.
|
|
Infections and infestations
Lung infection
|
0.00%
0/13 • From Informed Consent Form signature up to 28 days following the end of double-blind treatment (symptom recurrence observation period) or up to End of Open-Label Treatment Phase Visit (Days 29 to 38) for subjects continuing with open-label treatment
Adverse events collected during study visits as well as via an interactive voice response system (IVRS) while at home; clinical labs performed at baseline and end of each period; only treatment-emergent adverse events are displayed, ie. events that occurred or worsened in intensity on or after the first dose of study medication in each period.
|
7.7%
1/13 • Number of events 1 • From Informed Consent Form signature up to 28 days following the end of double-blind treatment (symptom recurrence observation period) or up to End of Open-Label Treatment Phase Visit (Days 29 to 38) for subjects continuing with open-label treatment
Adverse events collected during study visits as well as via an interactive voice response system (IVRS) while at home; clinical labs performed at baseline and end of each period; only treatment-emergent adverse events are displayed, ie. events that occurred or worsened in intensity on or after the first dose of study medication in each period.
|
0.00%
0/17 • From Informed Consent Form signature up to 28 days following the end of double-blind treatment (symptom recurrence observation period) or up to End of Open-Label Treatment Phase Visit (Days 29 to 38) for subjects continuing with open-label treatment
Adverse events collected during study visits as well as via an interactive voice response system (IVRS) while at home; clinical labs performed at baseline and end of each period; only treatment-emergent adverse events are displayed, ie. events that occurred or worsened in intensity on or after the first dose of study medication in each period.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/13 • From Informed Consent Form signature up to 28 days following the end of double-blind treatment (symptom recurrence observation period) or up to End of Open-Label Treatment Phase Visit (Days 29 to 38) for subjects continuing with open-label treatment
Adverse events collected during study visits as well as via an interactive voice response system (IVRS) while at home; clinical labs performed at baseline and end of each period; only treatment-emergent adverse events are displayed, ie. events that occurred or worsened in intensity on or after the first dose of study medication in each period.
|
7.7%
1/13 • Number of events 1 • From Informed Consent Form signature up to 28 days following the end of double-blind treatment (symptom recurrence observation period) or up to End of Open-Label Treatment Phase Visit (Days 29 to 38) for subjects continuing with open-label treatment
Adverse events collected during study visits as well as via an interactive voice response system (IVRS) while at home; clinical labs performed at baseline and end of each period; only treatment-emergent adverse events are displayed, ie. events that occurred or worsened in intensity on or after the first dose of study medication in each period.
|
0.00%
0/17 • From Informed Consent Form signature up to 28 days following the end of double-blind treatment (symptom recurrence observation period) or up to End of Open-Label Treatment Phase Visit (Days 29 to 38) for subjects continuing with open-label treatment
Adverse events collected during study visits as well as via an interactive voice response system (IVRS) while at home; clinical labs performed at baseline and end of each period; only treatment-emergent adverse events are displayed, ie. events that occurred or worsened in intensity on or after the first dose of study medication in each period.
|
|
Nervous system disorders
Headache
|
7.7%
1/13 • Number of events 1 • From Informed Consent Form signature up to 28 days following the end of double-blind treatment (symptom recurrence observation period) or up to End of Open-Label Treatment Phase Visit (Days 29 to 38) for subjects continuing with open-label treatment
Adverse events collected during study visits as well as via an interactive voice response system (IVRS) while at home; clinical labs performed at baseline and end of each period; only treatment-emergent adverse events are displayed, ie. events that occurred or worsened in intensity on or after the first dose of study medication in each period.
|
0.00%
0/13 • From Informed Consent Form signature up to 28 days following the end of double-blind treatment (symptom recurrence observation period) or up to End of Open-Label Treatment Phase Visit (Days 29 to 38) for subjects continuing with open-label treatment
Adverse events collected during study visits as well as via an interactive voice response system (IVRS) while at home; clinical labs performed at baseline and end of each period; only treatment-emergent adverse events are displayed, ie. events that occurred or worsened in intensity on or after the first dose of study medication in each period.
|
0.00%
0/17 • From Informed Consent Form signature up to 28 days following the end of double-blind treatment (symptom recurrence observation period) or up to End of Open-Label Treatment Phase Visit (Days 29 to 38) for subjects continuing with open-label treatment
Adverse events collected during study visits as well as via an interactive voice response system (IVRS) while at home; clinical labs performed at baseline and end of each period; only treatment-emergent adverse events are displayed, ie. events that occurred or worsened in intensity on or after the first dose of study medication in each period.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/13 • From Informed Consent Form signature up to 28 days following the end of double-blind treatment (symptom recurrence observation period) or up to End of Open-Label Treatment Phase Visit (Days 29 to 38) for subjects continuing with open-label treatment
Adverse events collected during study visits as well as via an interactive voice response system (IVRS) while at home; clinical labs performed at baseline and end of each period; only treatment-emergent adverse events are displayed, ie. events that occurred or worsened in intensity on or after the first dose of study medication in each period.
|
0.00%
0/13 • From Informed Consent Form signature up to 28 days following the end of double-blind treatment (symptom recurrence observation period) or up to End of Open-Label Treatment Phase Visit (Days 29 to 38) for subjects continuing with open-label treatment
Adverse events collected during study visits as well as via an interactive voice response system (IVRS) while at home; clinical labs performed at baseline and end of each period; only treatment-emergent adverse events are displayed, ie. events that occurred or worsened in intensity on or after the first dose of study medication in each period.
|
5.9%
1/17 • Number of events 1 • From Informed Consent Form signature up to 28 days following the end of double-blind treatment (symptom recurrence observation period) or up to End of Open-Label Treatment Phase Visit (Days 29 to 38) for subjects continuing with open-label treatment
Adverse events collected during study visits as well as via an interactive voice response system (IVRS) while at home; clinical labs performed at baseline and end of each period; only treatment-emergent adverse events are displayed, ie. events that occurred or worsened in intensity on or after the first dose of study medication in each period.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/13 • From Informed Consent Form signature up to 28 days following the end of double-blind treatment (symptom recurrence observation period) or up to End of Open-Label Treatment Phase Visit (Days 29 to 38) for subjects continuing with open-label treatment
Adverse events collected during study visits as well as via an interactive voice response system (IVRS) while at home; clinical labs performed at baseline and end of each period; only treatment-emergent adverse events are displayed, ie. events that occurred or worsened in intensity on or after the first dose of study medication in each period.
|
0.00%
0/13 • From Informed Consent Form signature up to 28 days following the end of double-blind treatment (symptom recurrence observation period) or up to End of Open-Label Treatment Phase Visit (Days 29 to 38) for subjects continuing with open-label treatment
Adverse events collected during study visits as well as via an interactive voice response system (IVRS) while at home; clinical labs performed at baseline and end of each period; only treatment-emergent adverse events are displayed, ie. events that occurred or worsened in intensity on or after the first dose of study medication in each period.
|
5.9%
1/17 • Number of events 1 • From Informed Consent Form signature up to 28 days following the end of double-blind treatment (symptom recurrence observation period) or up to End of Open-Label Treatment Phase Visit (Days 29 to 38) for subjects continuing with open-label treatment
Adverse events collected during study visits as well as via an interactive voice response system (IVRS) while at home; clinical labs performed at baseline and end of each period; only treatment-emergent adverse events are displayed, ie. events that occurred or worsened in intensity on or after the first dose of study medication in each period.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/13 • From Informed Consent Form signature up to 28 days following the end of double-blind treatment (symptom recurrence observation period) or up to End of Open-Label Treatment Phase Visit (Days 29 to 38) for subjects continuing with open-label treatment
Adverse events collected during study visits as well as via an interactive voice response system (IVRS) while at home; clinical labs performed at baseline and end of each period; only treatment-emergent adverse events are displayed, ie. events that occurred or worsened in intensity on or after the first dose of study medication in each period.
|
0.00%
0/13 • From Informed Consent Form signature up to 28 days following the end of double-blind treatment (symptom recurrence observation period) or up to End of Open-Label Treatment Phase Visit (Days 29 to 38) for subjects continuing with open-label treatment
Adverse events collected during study visits as well as via an interactive voice response system (IVRS) while at home; clinical labs performed at baseline and end of each period; only treatment-emergent adverse events are displayed, ie. events that occurred or worsened in intensity on or after the first dose of study medication in each period.
|
5.9%
1/17 • Number of events 1 • From Informed Consent Form signature up to 28 days following the end of double-blind treatment (symptom recurrence observation period) or up to End of Open-Label Treatment Phase Visit (Days 29 to 38) for subjects continuing with open-label treatment
Adverse events collected during study visits as well as via an interactive voice response system (IVRS) while at home; clinical labs performed at baseline and end of each period; only treatment-emergent adverse events are displayed, ie. events that occurred or worsened in intensity on or after the first dose of study medication in each period.
|
Additional Information
Robert Winkler MD, VP, Clinical Development and Operations
Aptalis Pharma US, Inc.
Phone: (908) 429-4479
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Restrictions vary in accordance with each agreement with the individual investigators. Sponsor will allow publication after a multi-center publication has been published or after an agreed period of time if no such multi-center publication is submitted for publication. Sponsor can ask that Sponsor's confidential information be removed from any publication and can defer publication for a period of time to allow for Sponsor to obtain patent or other intellectual property right protection.
- Publication restrictions are in place
Restriction type: OTHER