Trial Outcomes & Findings for A Study With Pentasa in Patients With Active Crohn's Disease (NCT NCT00862121)
NCT ID: NCT00862121
Last Updated: 2012-03-16
Results Overview
The Crohn's Disease Activity Index (CDAI) is a composite score to quantify symptoms of Crohn's disease. It has a range of 0-600; higher scores are worse. A responder is defined as a participant who achieved a reduction in the CDAI score to \<150 or a decrease in CDAI score of at least 70.
TERMINATED
PHASE3
20 participants
At Week 10, end of treatment
2012-03-16
Participant Flow
Participant milestones
| Measure |
Mesalazine
Mesalazine (Mesalamine) 2 g sachet; 6 g daily
|
Placebo
Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
12
|
|
Overall Study
Full Analysis Set (FAS)
|
7
|
11
|
|
Overall Study
Safety Analysis Set
|
8
|
11
|
|
Overall Study
COMPLETED
|
7
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
8
|
Reasons for withdrawal
| Measure |
Mesalazine
Mesalazine (Mesalamine) 2 g sachet; 6 g daily
|
Placebo
Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Lack of Efficacy
|
0
|
3
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Exclusion criterion violation
|
0
|
1
|
|
Overall Study
Incorrect randomisation
|
0
|
1
|
Baseline Characteristics
A Study With Pentasa in Patients With Active Crohn's Disease
Baseline characteristics by cohort
| Measure |
Mesalazine
n=7 Participants
Mesalazine (Mesalamine) 2 g sachet; 6 g daily
|
Placebo
n=11 Participants
Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
|
Total
n=18 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
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
37.6 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
37.5 years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
37.5 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
6 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Week 10, end of treatmentPopulation: The percentage of CDAI responders at Week 10 was analysed for the FAS (treated participants with post-baseline CDAI), Last Observation Carried Forward (LOCF).
The Crohn's Disease Activity Index (CDAI) is a composite score to quantify symptoms of Crohn's disease. It has a range of 0-600; higher scores are worse. A responder is defined as a participant who achieved a reduction in the CDAI score to \<150 or a decrease in CDAI score of at least 70.
Outcome measures
| Measure |
Mesalazine
n=7 Participants
Mesalazine (Mesalamine) 2 g sachet; 6 g daily
|
Placebo
n=11 Participants
Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
|
|---|---|---|
|
Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 10.
|
43 percentage of participants
|
55 percentage of participants
|
SECONDARY outcome
Timeframe: At Week 10, end of treatmentPopulation: Full Analysis Set (FAS), observed cases (OC), descriptive statistics only.
Fecal calprotectin is an inflammatory marker for the gastrointestinal tract. Higher values indicate more serious inflammation.
Outcome measures
| Measure |
Mesalazine
n=7 Participants
Mesalazine (Mesalamine) 2 g sachet; 6 g daily
|
Placebo
n=11 Participants
Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
|
|---|---|---|
|
Relative Change From Baseline to Week 10 in Fecal Calprotectin
Baseline
|
244.5 microgram/gram faeces
Standard Deviation 212.09
|
362 microgram/gram faeces
Standard Deviation 311.57
|
|
Relative Change From Baseline to Week 10 in Fecal Calprotectin
Week 10
|
181.57 microgram/gram faeces
Standard Deviation 216.15
|
1180.17 microgram/gram faeces
Standard Deviation 2295.34
|
SECONDARY outcome
Timeframe: Within the 10 week treatment periodPopulation: Full Analysis Set (OC). Descriptive statistics only.
Serum CRP is a laboratory measure of acute inflammation. Higher values are worse.
Outcome measures
| Measure |
Mesalazine
n=7 Participants
Mesalazine (Mesalamine) 2 g sachet; 6 g daily
|
Placebo
n=11 Participants
Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
|
|---|---|---|
|
Relative Change From Baseline to Each Visit in Serum C-reactive Protein (CRP)
Baseline
|
8.23 mg/L
Standard Deviation 5.71
|
10.25 mg/L
Standard Deviation 6.96
|
|
Relative Change From Baseline to Each Visit in Serum C-reactive Protein (CRP)
Week 10
|
7.76 mg/L
Standard Deviation 6
|
9.48 mg/L
Standard Deviation 8.41
|
SECONDARY outcome
Timeframe: Within the 10 week treatment periodPopulation: Full Analysis Set (OC). Descriptive statistics only.
The IBDQ is a measure of the impact of inflammatory bowel disease (IBD) on health-related quality-of-life (HRQL; mood, social activities, daily life, and IBD-related health worries). Higher scores are better; Total IBDQ score can range from 32 (very poor HRQL) to 224 (perfect HRQL).
Outcome measures
| Measure |
Mesalazine
n=7 Participants
Mesalazine (Mesalamine) 2 g sachet; 6 g daily
|
Placebo
n=11 Participants
Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
|
|---|---|---|
|
Relative Change From Baseline to Each Visit in Inflammatory Bowel Disease Questionnaire (IBDQ) Score
Baseline
|
138.57 IBDQ score
Standard Deviation 32.07
|
130.27 IBDQ score
Standard Deviation 29.32
|
|
Relative Change From Baseline to Each Visit in Inflammatory Bowel Disease Questionnaire (IBDQ) Score
Week 10
|
164 IBDQ score
Standard Deviation 24.99
|
121.88 IBDQ score
Standard Deviation 39.96
|
SECONDARY outcome
Timeframe: Within the 10 week treatment periodPopulation: Full Analysis Set (OC). Descriptive statistics only.
The WPAI\_CD Item 5 measures the impact of Crohn's disease on work productivity (while working). The score is recorded by the patient on a visual analog scale, from 0 to 10. Lower scores are better, while higher scores indicate greater negative effect on work productivity.
Outcome measures
| Measure |
Mesalazine
n=7 Participants
Mesalazine (Mesalamine) 2 g sachet; 6 g daily
|
Placebo
n=11 Participants
Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
|
|---|---|---|
|
Relative Change From Baseline to Each Visit in Work Productivity & Activity Impairment Questionnaire (WPAI_CD) Score Item 5 (Work Productivity)
Baseline
|
4.17 WPAI_CD Item 5 score
Standard Deviation 3.25
|
5 WPAI_CD Item 5 score
Standard Deviation 2.33
|
|
Relative Change From Baseline to Each Visit in Work Productivity & Activity Impairment Questionnaire (WPAI_CD) Score Item 5 (Work Productivity)
Week 10
|
1.83 WPAI_CD Item 5 score
Standard Deviation 1.47
|
4.4 WPAI_CD Item 5 score
Standard Deviation 2.07
|
SECONDARY outcome
Timeframe: At Week 10, end of treatmentPopulation: Safety Analysis Set (OC). Descriptive statistics only.
A lower creatinine clearance indicates worsening of renal function. Creatinine clearance was estimated from serum creatinine levels, using the Cockcroft-Gault formula.
Outcome measures
| Measure |
Mesalazine
n=8 Participants
Mesalazine (Mesalamine) 2 g sachet; 6 g daily
|
Placebo
n=11 Participants
Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
|
|---|---|---|
|
Relative Change From Baseline to Week 10 in Estimated Creatinine Clearance
Baseline
|
122.63 mL/min
Standard Deviation 26.91
|
102.55 mL/min
Standard Deviation 24.13
|
|
Relative Change From Baseline to Week 10 in Estimated Creatinine Clearance
Week 10
|
124 mL/min
Standard Deviation 32.14
|
105.11 mL/min
Standard Deviation 31.09
|
Adverse Events
Mesalazine
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Mesalazine
n=8 participants at risk
Mesalazine (Mesalamine) 2 g sachet; 6 g daily
|
Placebo
n=11 participants at risk
Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
12.5%
1/8 • Number of events 1
|
0.00%
0/11
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/8
|
9.1%
1/11 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
Gastric disorder
|
0.00%
0/8
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal hypermotility
|
12.5%
1/8 • Number of events 1
|
0.00%
0/11
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
12.5%
1/8 • Number of events 1
|
0.00%
0/11
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/8
|
9.1%
1/11 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
12.5%
1/8 • Number of events 1
|
0.00%
0/11
|
|
Infections and infestations
Urinary tract infection
|
12.5%
1/8 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
12.5%
1/8 • Number of events 1
|
0.00%
0/11
|
|
Nervous system disorders
Headache
|
0.00%
0/8
|
9.1%
1/11 • Number of events 1
|
|
Psychiatric disorders
Depression
|
0.00%
0/8
|
9.1%
1/11 • Number of events 1
|
|
Renal and urinary disorders
Pollakiuria
|
12.5%
1/8 • Number of events 1
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/8
|
9.1%
1/11 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/8
|
9.1%
1/11 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.
- Publication restrictions are in place
Restriction type: OTHER