Trial Outcomes & Findings for Amoxicillin Drug Interaction Study With MMX® Mesalazine/Mesalamine (NCT NCT01442688)
NCT ID: NCT01442688
Last Updated: 2021-06-09
Results Overview
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
62 participants
Primary outcome timeframe
Assessed over a 24-hour period starting post-dose on day 4
Results posted on
2021-06-09
Participant Flow
Participant milestones
| Measure |
Amoxicillin + MMX Placebo First
MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4 for first intervention. Then, MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4 for second intervention.
|
Amoxicillin + MMX Mesalazine/Mesalamine First
MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4 for first intervention. Then, MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4 for second intervention.
|
|---|---|---|
|
First Intervention
STARTED
|
31
|
31
|
|
First Intervention
COMPLETED
|
29
|
31
|
|
First Intervention
NOT COMPLETED
|
2
|
0
|
|
Second Intervention
STARTED
|
29
|
31
|
|
Second Intervention
COMPLETED
|
28
|
31
|
|
Second Intervention
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Amoxicillin + MMX Placebo First
MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4 for first intervention. Then, MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4 for second intervention.
|
Amoxicillin + MMX Mesalazine/Mesalamine First
MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4 for first intervention. Then, MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4 for second intervention.
|
|---|---|---|
|
First Intervention
Withdrawal by Subject
|
1
|
0
|
|
First Intervention
subject incarcerated
|
1
|
0
|
|
Second Intervention
Adverse Event
|
1
|
0
|
Baseline Characteristics
Amoxicillin Drug Interaction Study With MMX® Mesalazine/Mesalamine
Baseline characteristics by cohort
| Measure |
Amoxicillin + MMX Placebo First
n=31 Participants
MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4 for first intervention. Then, MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4 for second intervention.
|
Amoxicillin + MMX Mesalazine/Mesalamine First
n=31 Participants
MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4 for first intervention. Then, MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4 for second intervention.
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.3 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
30.1 years
STANDARD_DEVIATION 8.91 • n=7 Participants
|
32.2 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Age, Customized
Between 18 and 55 years
|
31 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed over a 24-hour period starting post-dose on day 4Population: The Pharmacokinetic Analysis Set was defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. The Safety Analysis Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 postdose safety assessment.
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Outcome measures
| Measure |
Amoxicillin + MMX Placebo
n=60 Participants
MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4.
|
Amoxicillin + MMX Mesalazine/Mesalamine
n=59 Participants
MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4.
|
|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) for Amoxicillin
|
27.8 h*ug/ml
Standard Deviation 5.02
|
28.3 h*ug/ml
Standard Deviation 6.37
|
PRIMARY outcome
Timeframe: Assessed over a 24-hour period starting post-dose on day 4Population: Pharmacokinetic Analysis Set
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Outcome measures
| Measure |
Amoxicillin + MMX Placebo
n=60 Participants
MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4.
|
Amoxicillin + MMX Mesalazine/Mesalamine
n=59 Participants
MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4.
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax) for Amoxicillin
|
10.3 ug/ml
Standard Deviation 2.59
|
10.2 ug/ml
Standard Deviation 2.89
|
Adverse Events
Amoxicillin + MMX Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Amoxicillin + MMX Mesalazine/Mesalamine
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Amoxicillin + MMX Placebo
n=62 participants at risk
MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4.
|
Amoxicillin + MMX Mesalazine/Mesalamine
n=59 participants at risk
MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4.
|
|---|---|---|
|
Cardiac disorders
Tachycardia
|
0.00%
0/62
|
1.7%
1/59 • Number of events 1
|
|
Ear and labyrinth disorders
Ear discomfort
|
1.6%
1/62 • Number of events 1
|
0.00%
0/59
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/62
|
1.7%
1/59 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
1.6%
1/62 • Number of events 1
|
0.00%
0/59
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/62
|
3.4%
2/59 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
1.6%
1/62 • Number of events 1
|
0.00%
0/59
|
|
Gastrointestinal disorders
Dyspnea
|
1.6%
1/62 • Number of events 2
|
0.00%
0/59
|
|
Gastrointestinal disorders
Nausea
|
3.2%
2/62 • Number of events 2
|
0.00%
0/59
|
|
Gastrointestinal disorders
Vomiting
|
3.2%
2/62 • Number of events 2
|
0.00%
0/59
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
0.00%
0/62
|
1.7%
1/59 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/62
|
1.7%
1/59 • Number of events 1
|
|
Nervous system disorders
Headache
|
6.5%
4/62 • Number of events 5
|
5.1%
3/59 • Number of events 3
|
|
Nervous system disorders
Presyncope
|
0.00%
0/62
|
1.7%
1/59 • Number of events 1
|
|
Nervous system disorders
Somnolence
|
0.00%
0/62
|
1.7%
1/59 • Number of events 1
|
|
Renal and urinary disorders
Hematuria
|
1.6%
1/62 • Number of events 1
|
0.00%
0/59
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.6%
1/62 • Number of events 1
|
0.00%
0/59
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/62
|
1.7%
1/59 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.6%
1/62 • Number of events 1
|
0.00%
0/59
|
|
Skin and subcutaneous tissue disorders
Rash maculopapular
|
0.00%
0/62
|
3.4%
2/59 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
- Publication restrictions are in place
Restriction type: OTHER