Trial Outcomes & Findings for Mesalamine 4 gm/60 mL Rectal Enema (NCT NCT00840203)
NCT ID: NCT00840203
Last Updated: 2024-08-19
Results Overview
Bioequivalence based on Cmax
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
72 participants
Primary outcome timeframe
Blood samples collected over 48 hour period
Results posted on
2024-08-19
Participant Flow
Participant milestones
| Measure |
Mesalamine (Test) First
Mesalamine 4gm/60mL Rectal Enema (test) dosed in first period followed by Rowasa® 4gm/60mL Rectal Enema (reference) dosed in second period
|
Rowasa® (Reference) First
Rowasa® 4gm/60mL Rectal Enema (reference) dosed in first period followed by Mesalamine 4gm/60mL Rectal Enema (test) dosed in second period
|
|---|---|---|
|
First Intervention
STARTED
|
37
|
35
|
|
First Intervention
COMPLETED
|
36
|
34
|
|
First Intervention
NOT COMPLETED
|
1
|
1
|
|
Washout
STARTED
|
36
|
34
|
|
Washout
COMPLETED
|
35
|
34
|
|
Washout
NOT COMPLETED
|
1
|
0
|
|
Second Intervention
STARTED
|
35
|
34
|
|
Second Intervention
COMPLETED
|
35
|
34
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Mesalamine (Test) First
Mesalamine 4gm/60mL Rectal Enema (test) dosed in first period followed by Rowasa® 4gm/60mL Rectal Enema (reference) dosed in second period
|
Rowasa® (Reference) First
Rowasa® 4gm/60mL Rectal Enema (reference) dosed in first period followed by Mesalamine 4gm/60mL Rectal Enema (test) dosed in second period
|
|---|---|---|
|
First Intervention
Protocol Violation
|
1
|
1
|
|
Washout
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Mesalamine 4 gm/60 mL Rectal Enema
Baseline characteristics by cohort
| Measure |
Mesalamine (Test) First
n=37 Participants
Mesalamine 4gm/60mL Rectal Enema (test) dosed in first period followed by Rowasa® 4gm/60mL Rectal Enema (reference) dosed in second period
|
Rowasa® (Reference) First
n=35 Participants
Rowasa® 4gm/60mL Rectal Enema (reference) dosed in first period followed by Mesalamine 4gm/60mL Rectal Enema (test) dosed in second period
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
37 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
72 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
18 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
17 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Biracial
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=99 Participants
|
35 participants
n=107 Participants
|
72 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Blood samples collected over 48 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Bioequivalence based on Cmax
Outcome measures
| Measure |
Mesalamine
n=69 Participants
Mesalamine 4gm/60mL Rectal Enema (test) dosed in either period
|
Rowasa®
n=69 Participants
Rowasa® 4gm/60mL Rectal Enema (reference) dosed in either period
|
|---|---|---|
|
Cmax - Maximum Observed Concentration
|
1451.739 ng/mL
Standard Deviation 718.488
|
1500.290 ng/mL
Standard Deviation 778.674
|
PRIMARY outcome
Timeframe: Blood samples collected over 48 hour periodPopulation: AUC0-inf was not able to be estimated for all completing subjects
Bioequivalence based on AUC0-inf
Outcome measures
| Measure |
Mesalamine
n=52 Participants
Mesalamine 4gm/60mL Rectal Enema (test) dosed in either period
|
Rowasa®
n=56 Participants
Rowasa® 4gm/60mL Rectal Enema (reference) dosed in either period
|
|---|---|---|
|
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
|
24458.932 ng*h/mL
Standard Deviation 16649.166
|
26862.895 ng*h/mL
Standard Deviation 21419.555
|
PRIMARY outcome
Timeframe: Blood samples collected over 48 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Bioequivalence based on AUC0-t
Outcome measures
| Measure |
Mesalamine
n=69 Participants
Mesalamine 4gm/60mL Rectal Enema (test) dosed in either period
|
Rowasa®
n=69 Participants
Rowasa® 4gm/60mL Rectal Enema (reference) dosed in either period
|
|---|---|---|
|
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
|
21543.597 ng*h/mL
Standard Deviation 15674.400
|
22911.830 ng*h/mL
Standard Deviation 15380.728
|
SECONDARY outcome
Timeframe: Blood samples collected over 48 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Cmax results for N-Acetylmesalamine metabolite
Outcome measures
| Measure |
Mesalamine
n=69 Participants
Mesalamine 4gm/60mL Rectal Enema (test) dosed in either period
|
Rowasa®
n=69 Participants
Rowasa® 4gm/60mL Rectal Enema (reference) dosed in either period
|
|---|---|---|
|
Cmax - Maximum Observed Concentration
|
2274.652 ng/mL
Standard Deviation 934.469
|
2284.884 ng/mL
Standard Deviation 857.980
|
SECONDARY outcome
Timeframe: Blood samples collected over 48 hour periodPopulation: AUC0-inf was not able to be estimated for all completing subjects
AUC0-inf results for N-Acetylmesalamine metabolite
Outcome measures
| Measure |
Mesalamine
n=60 Participants
Mesalamine 4gm/60mL Rectal Enema (test) dosed in either period
|
Rowasa®
n=58 Participants
Rowasa® 4gm/60mL Rectal Enema (reference) dosed in either period
|
|---|---|---|
|
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
|
46564.373 ng*h/mL
Standard Deviation 29109.234
|
49692.278 ng*h/mL
Standard Deviation 32182.649
|
SECONDARY outcome
Timeframe: Blood samples collected over 48 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
AUC0-t results for N-Acetylmesalamine metabolite
Outcome measures
| Measure |
Mesalamine
n=69 Participants
Mesalamine 4gm/60mL Rectal Enema (test) dosed in either period
|
Rowasa®
n=69 Participants
Rowasa® 4gm/60mL Rectal Enema (reference) dosed in either period
|
|---|---|---|
|
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
|
40873.915 ng*h/mL
Standard Deviation 25272.348
|
42644.677 ng*h/mL
Standard Deviation 24335.847
|
Adverse Events
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigator is not permitted to discuss or publish trial results.
- Publication restrictions are in place
Restriction type: OTHER