Trial Outcomes & Findings for (CB-01-02/04) Extension Study of Budesonide Multi-Matrix System (MMX) 6 mg in Maintenance Of Remission In Patients With Ulcerative Colitis. (NCT NCT00801723)
NCT ID: NCT00801723
Last Updated: 2020-08-31
Results Overview
Clinical remission was defined as the combined absence of recurrence of rectal bleeding and absence of increased stool frequency.
COMPLETED
PHASE3
123 participants
1, 3, 6, 9, and 12 months
2020-08-31
Participant Flow
Participant milestones
| Measure |
2: Placebo
One placebo tablet self-administered by the patients with a glass of water, in the morning after breakfast.
Placebo Tablet: Placebo Tablet once daily.
|
1: Budesonide MMX® 6 mg
One Budesonide-MMX® 6 mg tablet self-administered by the patients with a glass of water, in the morning after breakfast.
Budesonide MMX 6 mg Tablet: Budesonide MMX 6 mg Tablet once daily.
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
62
|
|
Overall Study
COMPLETED
|
25
|
27
|
|
Overall Study
NOT COMPLETED
|
36
|
35
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
(CB-01-02/04) Extension Study of Budesonide Multi-Matrix System (MMX) 6 mg in Maintenance Of Remission In Patients With Ulcerative Colitis.
Baseline characteristics by cohort
| Measure |
2: Placebo
n=61 Participants
One placebo tablet self-administered by the patients with a glass of water, in the morning after breakfast.
Placebo Tablet: Placebo Tablet once daily.
|
1: Budesonide MMX® 6 mg
n=62 Participants
One Budesonide-MMX® 6 mg tablet self-administered by the patients with a glass of water, in the morning after breakfast.
Budesonide MMX 6 mg Tablet: Budesonide MMX 6 mg Tablet once daily.
|
Total
n=123 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.0 years
STANDARD_DEVIATION 11.77 • n=99 Participants
|
42.9 years
STANDARD_DEVIATION 12.65 • n=107 Participants
|
42.5 years
STANDARD_DEVIATION 12.21 • n=206 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
69 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1, 3, 6, 9, and 12 monthsPopulation: Number of participants with sufficient diary data to enable determination of clinical remission status at the indicated visit.
Clinical remission was defined as the combined absence of recurrence of rectal bleeding and absence of increased stool frequency.
Outcome measures
| Measure |
2: Placebo
n=32 Participants
One placebo tablet self-administered by the patients with a glass of water, in the morning after breakfast.
Placebo Tablet: Placebo Tablet once daily.
|
1: Budesonide MMX® 6 mg
n=39 Participants
One Budesonide-MMX® 6 mg tablet self-administered by the patients with a glass of water, in the morning after breakfast.
Budesonide MMX 6 mg Tablet: Budesonide MMX 6 mg Tablet once daily.
|
|---|---|---|
|
Percentage of Participants Achieving Clinical Remission
1 month
|
76.7 percentage of participants
|
88.2 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission
3 months
|
92.0 percentage of participants
|
96.8 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission
6 months
|
76.2 percentage of participants
|
80.0 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission
9 months
|
86.7 percentage of participants
|
95.0 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission
12 months
|
84.6 percentage of participants
|
93.3 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Participants with sufficient diary data to enable determination of clinical relapse status.
Clinical relapse was defined as the recurrence of rectal bleeding and/or an abnormal stool frequency \[≥ 1-2 stools/day above normal for the participant. Clinical remission/relapse status was based on participant diary entries prior to each scheduled visit.
Outcome measures
| Measure |
2: Placebo
n=32 Participants
One placebo tablet self-administered by the patients with a glass of water, in the morning after breakfast.
Placebo Tablet: Placebo Tablet once daily.
|
1: Budesonide MMX® 6 mg
n=39 Participants
One Budesonide-MMX® 6 mg tablet self-administered by the patients with a glass of water, in the morning after breakfast.
Budesonide MMX 6 mg Tablet: Budesonide MMX 6 mg Tablet once daily.
|
|---|---|---|
|
Percentage of Participants With Clinical Relapse
|
19 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Participants with sufficient index score data to enable determination of endoscopic relapse status.
Endoscopic relapse was defined as an increase of ≥ 2 points in the Endoscopic Index score from the value calculated at baseline. The score is comprised of four components (granulated scattering reflected light, vascular pattern, vulnerability of mucosa, and mucosal damage). Scores range from 0 to 12, and higher scores indicate more severe (worse) endoscopic findings.
Outcome measures
| Measure |
2: Placebo
n=32 Participants
One placebo tablet self-administered by the patients with a glass of water, in the morning after breakfast.
Placebo Tablet: Placebo Tablet once daily.
|
1: Budesonide MMX® 6 mg
n=39 Participants
One Budesonide-MMX® 6 mg tablet self-administered by the patients with a glass of water, in the morning after breakfast.
Budesonide MMX 6 mg Tablet: Budesonide MMX 6 mg Tablet once daily.
|
|---|---|---|
|
Percentage of Participants With Endoscopic Relapse
|
16 Participants
|
27 Participants
|
Adverse Events
2: Placebo
1: Budesonide MMX® 6 mg
Serious adverse events
| Measure |
2: Placebo
n=61 participants at risk
One placebo tablet self-administered by the patients with a glass of water, in the morning after breakfast.
Placebo Tablet: Placebo Tablet once daily.
|
1: Budesonide MMX® 6 mg
n=62 participants at risk
One Budesonide-MMX® 6 mg tablet self-administered by the patients with a glass of water, in the morning after breakfast.
Budesonide MMX 6 mg Tablet: Budesonide MMX 6 mg Tablet once daily.
|
|---|---|---|
|
Infections and infestations
Lobar pneumonia
|
1.6%
1/61 • 12 months
|
0.00%
0/62 • 12 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/61 • 12 months
|
1.6%
1/62 • 12 months
|
Other adverse events
| Measure |
2: Placebo
n=61 participants at risk
One placebo tablet self-administered by the patients with a glass of water, in the morning after breakfast.
Placebo Tablet: Placebo Tablet once daily.
|
1: Budesonide MMX® 6 mg
n=62 participants at risk
One Budesonide-MMX® 6 mg tablet self-administered by the patients with a glass of water, in the morning after breakfast.
Budesonide MMX 6 mg Tablet: Budesonide MMX 6 mg Tablet once daily.
|
|---|---|---|
|
Gastrointestinal disorders
Colitis ulcerative
|
26.2%
16/61 • 12 months
|
17.7%
11/62 • 12 months
|
|
Gastrointestinal disorders
Abdominal pain
|
8.2%
5/61 • 12 months
|
9.7%
6/62 • 12 months
|
|
Nervous system disorders
Headache
|
3.3%
2/61 • 12 months
|
6.5%
4/62 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
8.2%
5/61 • 12 months
|
1.6%
1/62 • 12 months
|
|
Gastrointestinal disorders
Frequent bowel movements
|
1.6%
1/61 • 12 months
|
6.5%
4/62 • 12 months
|
|
Blood and lymphatic system disorders
Haematochezia
|
1.6%
1/61 • 12 months
|
6.5%
4/62 • 12 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/61 • 12 months
|
6.5%
4/62 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Contact sponsor directly for details.
- Publication restrictions are in place
Restriction type: OTHER