Trial Outcomes & Findings for Multicenter Randomized Parallel Group Phase III Study Comparing the Bowel Cleansing Efficacy, Safety and Tolerability of NER1006 Versus a Sodium Picosulfate and Magnesium Salt Solution Using Day Before-Only Dosing Regimen in Adults. (NCT NCT02273141)
NCT ID: NCT02273141
Last Updated: 2018-05-15
Results Overview
The overall quality of bowel cleansing was assessed by a blinded central reader (an experienced and trained colonoscopist) using the segmental scores of the Harefield Cleansing Scale (HCS). A final HCS grading of A, B, C or D was derived. Grades A and B are classified as successful (i.e. all mucosa could be visualized) and C and D are classified as unsuccessful. Comparison of overall success of cleansing with NER1006 versus SP+MS was evaluated using a non-inferiority study design.
COMPLETED
PHASE3
515 participants
One day (day before colonoscopy)
2018-05-15
Participant Flow
The trial recruited out/in-patients at 19 medical centres in Europe, from November 2014 to July 2015.
Participant milestones
| Measure |
SP+MS, Day Before-Only Dosing
SP+MS 1-Day Day Before-Only Split-Dosing Regimen (to commence on the morning of the day before colonoscopy).
|
NER1006, Day Before-Only Dosing
NER1006 1-Day Day Before-Only Split-Dosing Regimen (to commence on the evening of the day before colonoscopy).
|
|---|---|---|
|
Overall Study
STARTED
|
257
|
258
|
|
Overall Study
COMPLETED
|
240
|
233
|
|
Overall Study
NOT COMPLETED
|
17
|
25
|
Reasons for withdrawal
| Measure |
SP+MS, Day Before-Only Dosing
SP+MS 1-Day Day Before-Only Split-Dosing Regimen (to commence on the morning of the day before colonoscopy).
|
NER1006, Day Before-Only Dosing
NER1006 1-Day Day Before-Only Split-Dosing Regimen (to commence on the evening of the day before colonoscopy).
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
10
|
15
|
|
Overall Study
Various
|
6
|
6
|
Baseline Characteristics
Multicenter Randomized Parallel Group Phase III Study Comparing the Bowel Cleansing Efficacy, Safety and Tolerability of NER1006 Versus a Sodium Picosulfate and Magnesium Salt Solution Using Day Before-Only Dosing Regimen in Adults.
Baseline characteristics by cohort
| Measure |
SP+MS, Day Before-Only Dosing
n=257 Participants
SP+MS 1-Day Day Before-Only Split-Dosing Regimen (to commence on the moring of the day before colonoscopy).
|
NER1006, Day Before-Only Dosing
n=258 Participants
NER1006 1-Day Day Before-Only Split-Dosing Regimen (to commence on the evening of the day before colonoscopy).
|
Total
n=515 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
207 Participants
n=5 Participants
|
203 Participants
n=7 Participants
|
410 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
50 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Age, Continuous
|
52.9 years
STANDARD_DEVIATION 13.35 • n=5 Participants
|
54.6 years
STANDARD_DEVIATION 11.64 • n=7 Participants
|
53.8 years
STANDARD_DEVIATION 12.50 • n=5 Participants
|
|
Sex: Female, Male
Female
|
174 Participants
n=5 Participants
|
168 Participants
n=7 Participants
|
342 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
83 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
173 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One day (day before colonoscopy)Population: The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.
The overall quality of bowel cleansing was assessed by a blinded central reader (an experienced and trained colonoscopist) using the segmental scores of the Harefield Cleansing Scale (HCS). A final HCS grading of A, B, C or D was derived. Grades A and B are classified as successful (i.e. all mucosa could be visualized) and C and D are classified as unsuccessful. Comparison of overall success of cleansing with NER1006 versus SP+MS was evaluated using a non-inferiority study design.
Outcome measures
| Measure |
SP+MS, Day Before-Only Dosing
n=251 Participants
SP+MS 1-Day Day Before-Only Split-Dosing Regimen (to commence on the morning of the day before colonoscopy).
|
NER1006, Day Before-Only Dosing
n=250 Participants
NER1006 1-Day Day Before-Only Split-Dosing Regimen (to commence on the evening of the day before colonoscopy).
|
|---|---|---|
|
Number of Patients With Successful Bowel Cleansing (Overall Colon)
Successful
|
135 Participants
|
155 Participants
|
|
Number of Patients With Successful Bowel Cleansing (Overall Colon)
Failure
|
116 Participants
|
95 Participants
|
PRIMARY outcome
Timeframe: One day (day before colonoscopy)Population: The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.
The overall quality of bowel cleansing was assessed by a blinded central reader (an experienced and trained colonoscopist) using the segmental scores of the Harefield Cleansing Scale (HCS). Highly effective cleansing in the colon ascendens corresponded to scores 3 (Good) or 4 (Excellent) of the HCS. Adequate plus failure of cleansing corresponded to score 0-2. Comparison of 'Excellent plus good' cleansing of the colon ascendens using NER1006 versus SP+MS was evaluated using a non-inferiority study design.
Outcome measures
| Measure |
SP+MS, Day Before-Only Dosing
n=251 Participants
SP+MS 1-Day Day Before-Only Split-Dosing Regimen (to commence on the morning of the day before colonoscopy).
|
NER1006, Day Before-Only Dosing
n=250 Participants
NER1006 1-Day Day Before-Only Split-Dosing Regimen (to commence on the evening of the day before colonoscopy).
|
|---|---|---|
|
Number of Patients With 'Excellent Plus Good' (Highly Effective) Bowel Cleansing (Colon Ascendens)
Excellent plus good
|
3 Participants
|
11 Participants
|
|
Number of Patients With 'Excellent Plus Good' (Highly Effective) Bowel Cleansing (Colon Ascendens)
Adequate plus failure
|
248 Participants
|
239 Participants
|
SECONDARY outcome
Timeframe: One day (day before colonoscopy).Population: The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.
Comparison of the number of patients with at least one adenoma detected in the colon ascendens when NER1006 is used for bowel cleansing versus SP+MS. Adenoma detection rate (ADR) defined as the number of patients with at least one adenoma in the colon ascendens.
Outcome measures
| Measure |
SP+MS, Day Before-Only Dosing
n=251 Participants
SP+MS 1-Day Day Before-Only Split-Dosing Regimen (to commence on the morning of the day before colonoscopy).
|
NER1006, Day Before-Only Dosing
n=250 Participants
NER1006 1-Day Day Before-Only Split-Dosing Regimen (to commence on the evening of the day before colonoscopy).
|
|---|---|---|
|
Adenoma Detection Rate (Colon Ascendens)
Patients with no adenomas detected
|
241 Participants
|
234 Participants
|
|
Adenoma Detection Rate (Colon Ascendens)
Patients with at least one adenoma detected
|
10 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: One day (day before colonoscopy)Population: The overall number of participants analyzed was based on the mFAS. This included all randomized patients with the exception of any patient who was randomized but subsequently failed to meet entry criteria and in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug (n=501).
Comparison of the number of patients with at least one adenoma detected in the overall colon when NER1006 is used for bowel cleansing versus SP+MS. Adenoma detection rate (ADR) defined as the number of patients with at least one adenoma in the overall colon.
Outcome measures
| Measure |
SP+MS, Day Before-Only Dosing
n=251 Participants
SP+MS 1-Day Day Before-Only Split-Dosing Regimen (to commence on the morning of the day before colonoscopy).
|
NER1006, Day Before-Only Dosing
n=250 Participants
NER1006 1-Day Day Before-Only Split-Dosing Regimen (to commence on the evening of the day before colonoscopy).
|
|---|---|---|
|
Adenoma Detection Rate (Overall Colon)
Patients with no adenomas detected
|
204 Participants
|
195 Participants
|
|
Adenoma Detection Rate (Overall Colon)
Patients with at least one adenoma detected
|
47 Participants
|
55 Participants
|
SECONDARY outcome
Timeframe: One day (day before colonoscopy)Population: The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.
Comparison of the number of patients with at least one polyp detected in the colon ascendens when NER1006 is used for bowel cleansing versus SP+MS. Polyp detection rate (PDR) defined as the number of patients with at least one polyp in the colon ascendens.
Outcome measures
| Measure |
SP+MS, Day Before-Only Dosing
n=251 Participants
SP+MS 1-Day Day Before-Only Split-Dosing Regimen (to commence on the morning of the day before colonoscopy).
|
NER1006, Day Before-Only Dosing
n=250 Participants
NER1006 1-Day Day Before-Only Split-Dosing Regimen (to commence on the evening of the day before colonoscopy).
|
|---|---|---|
|
Polyp Detection Rate (Colon Ascendens)
Patients with no polyps detected
|
232 Participants
|
220 Participants
|
|
Polyp Detection Rate (Colon Ascendens)
Patients with at least one polyp detected
|
19 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: One day (day before colonoscopy)Population: The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.
Comparison of the number of patients with at least one polyp detected in the overall colon when NER1006 is used for bowel cleansing versus SP+MS. Polyp detection rate (PDR) defined as the number of patients with at least one polyp in the overall colon.
Outcome measures
| Measure |
SP+MS, Day Before-Only Dosing
n=251 Participants
SP+MS 1-Day Day Before-Only Split-Dosing Regimen (to commence on the morning of the day before colonoscopy).
|
NER1006, Day Before-Only Dosing
n=250 Participants
NER1006 1-Day Day Before-Only Split-Dosing Regimen (to commence on the evening of the day before colonoscopy).
|
|---|---|---|
|
Polyp Detection Rate (Overall Colon)
Patients with no polyps detected
|
160 Participants
|
152 Participants
|
|
Polyp Detection Rate (Overall Colon)
Patients with at least one polyp detected
|
91 Participants
|
98 Participants
|
Adverse Events
SP+MS, Day Before-Only Dosing
NER1006, Day Before-Only Dosing
Serious adverse events
| Measure |
SP+MS, Day Before-Only Dosing
n=241 participants at risk
SP+MS 1-Day Day Before-Only Split-Dosing Regimen (to commence on the morning of the day before colonoscopy).
|
NER1006, Day Before-Only Dosing
n=235 participants at risk
NER1006 1-Day Day Before-Only Split-Dosing Regimen (to commence on the evening of the day before colonoscopy).
|
|---|---|---|
|
Infections and infestations
Ovarian abscess
|
0.00%
0/241 • Morning of Day 1 (first dose) to Day 9 (final clinic visit)
Safety analyses were based on the safety population which included all randomized patients for whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=476). The analyses are based on treatment emergent adverse events (TEAEs). There were no deaths and the serious TEAE was not related to treatment.
|
0.43%
1/235 • Number of events 1 • Morning of Day 1 (first dose) to Day 9 (final clinic visit)
Safety analyses were based on the safety population which included all randomized patients for whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=476). The analyses are based on treatment emergent adverse events (TEAEs). There were no deaths and the serious TEAE was not related to treatment.
|
Other adverse events
| Measure |
SP+MS, Day Before-Only Dosing
n=241 participants at risk
SP+MS 1-Day Day Before-Only Split-Dosing Regimen (to commence on the morning of the day before colonoscopy).
|
NER1006, Day Before-Only Dosing
n=235 participants at risk
NER1006 1-Day Day Before-Only Split-Dosing Regimen (to commence on the evening of the day before colonoscopy).
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
3/241 • Number of events 3 • Morning of Day 1 (first dose) to Day 9 (final clinic visit)
Safety analyses were based on the safety population which included all randomized patients for whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=476). The analyses are based on treatment emergent adverse events (TEAEs). There were no deaths and the serious TEAE was not related to treatment.
|
3.4%
8/235 • Number of events 8 • Morning of Day 1 (first dose) to Day 9 (final clinic visit)
Safety analyses were based on the safety population which included all randomized patients for whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=476). The analyses are based on treatment emergent adverse events (TEAEs). There were no deaths and the serious TEAE was not related to treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.83%
2/241 • Number of events 2 • Morning of Day 1 (first dose) to Day 9 (final clinic visit)
Safety analyses were based on the safety population which included all randomized patients for whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=476). The analyses are based on treatment emergent adverse events (TEAEs). There were no deaths and the serious TEAE was not related to treatment.
|
2.6%
6/235 • Number of events 6 • Morning of Day 1 (first dose) to Day 9 (final clinic visit)
Safety analyses were based on the safety population which included all randomized patients for whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=476). The analyses are based on treatment emergent adverse events (TEAEs). There were no deaths and the serious TEAE was not related to treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/241 • Morning of Day 1 (first dose) to Day 9 (final clinic visit)
Safety analyses were based on the safety population which included all randomized patients for whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=476). The analyses are based on treatment emergent adverse events (TEAEs). There were no deaths and the serious TEAE was not related to treatment.
|
4.7%
11/235 • Number of events 11 • Morning of Day 1 (first dose) to Day 9 (final clinic visit)
Safety analyses were based on the safety population which included all randomized patients for whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=476). The analyses are based on treatment emergent adverse events (TEAEs). There were no deaths and the serious TEAE was not related to treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/241 • Morning of Day 1 (first dose) to Day 9 (final clinic visit)
Safety analyses were based on the safety population which included all randomized patients for whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=476). The analyses are based on treatment emergent adverse events (TEAEs). There were no deaths and the serious TEAE was not related to treatment.
|
1.3%
3/235 • Number of events 3 • Morning of Day 1 (first dose) to Day 9 (final clinic visit)
Safety analyses were based on the safety population which included all randomized patients for whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=476). The analyses are based on treatment emergent adverse events (TEAEs). There were no deaths and the serious TEAE was not related to treatment.
|
|
Nervous system disorders
Headache
|
1.7%
4/241 • Number of events 4 • Morning of Day 1 (first dose) to Day 9 (final clinic visit)
Safety analyses were based on the safety population which included all randomized patients for whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=476). The analyses are based on treatment emergent adverse events (TEAEs). There were no deaths and the serious TEAE was not related to treatment.
|
1.7%
4/235 • Number of events 5 • Morning of Day 1 (first dose) to Day 9 (final clinic visit)
Safety analyses were based on the safety population which included all randomized patients for whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=476). The analyses are based on treatment emergent adverse events (TEAEs). There were no deaths and the serious TEAE was not related to treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place