Trial · NCT01469637

Sulfamethoxazole Drug Interaction Study With MMX® Mesalazine/Mesalamine

NCT01469637, Phase 1, Completed, Shire; results first posted 2012-10-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Sulfamethoxazole Drug Interaction Study With MMX® Mesalazine/Mesalamine. Trials, record NCT01469637. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01469637

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Sulfamethoxazole Drug Interaction Study With MMX® Mesalazine/Mesalamine
NCT number: NCT01469637
Status: Completed
Phases: Phase 1
Enrollment: 44 participants, actual
Lead sponsor: Shire
Conditions: Healthy
Interventions: sulfamethoxazole + MMX placebo, Sulfamethoxazole + MMX Mesalazine/mesalamine
First posted: 2011-11-10
Last updated: 2021-07-13
Results first posted: 2012-10-25

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Area Under the Plasma Concentration Versus Time Curve Within a Dosing Interval at Steady-State (AUCss) for Sulfamethoxazole	Assessed over a 24-hour period starting post-dose on day 4	AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure of how much and how long a drug stays in a body.
Primary	Maximum Plasma Concentration at Steady-State (Cmaxss) for Sulfamethoxazole	Assessed over a 24-hour period starting post-dose on day 4	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.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Area Under the Plasma Concentration Versus Time Curve Within a Dosing Interval at Steady-State (AUCss) for Sulfamethoxazole	Assessed over a 24-hour period starting post-dose on day 4	Pharmacokinetic Analysis Set defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set defined as subjects who took at least 1 dose of investigational product and had at least 1 postdose safety assessment.	h*ug/ml	MEAN
PRIMARY	Maximum Plasma Concentration at Steady-State (Cmaxss) for Sulfamethoxazole	Assessed over a 24-hour period starting post-dose on day 4	Pharmacokinetic Analysis Set defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set defined as subjects who took at least 1 dose of investigational product and had at least 1 postdose safety assessment.	ug/ml	MEAN

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Area Under the Plasma Concentration Versus Time Curve Within a Dosing Interval at Steady-State (AUCss) for Sulfamethoxazole	Sulfamethoxazole + MMX Placebo	786	Standard Deviation 169	h*ug/ml
Area Under the Plasma Concentration Versus Time Curve Within a Dosing Interval at Steady-State (AUCss) for Sulfamethoxazole	Sulfamethoxazole + MMX Mesalazine/Mesalamine	909	Standard Deviation 198	h*ug/ml
Maximum Plasma Concentration at Steady-State (Cmaxss) for Sulfamethoxazole	Sulfamethoxazole + MMX Placebo	89.1	Standard Deviation 16.3	ug/ml
Maximum Plasma Concentration at Steady-State (Cmaxss) for Sulfamethoxazole	Sulfamethoxazole + MMX Mesalazine/Mesalamine	100	Standard Deviation 20.2	ug/ml

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
First Intervention	STARTED	Sulfamethoxazole + MMX Placebo First	22
First Intervention	STARTED	Sulfamethoxazole + MMX Mesalazine/Mesalamine First	22
First Intervention	COMPLETED	Sulfamethoxazole + MMX Placebo First	22
First Intervention	COMPLETED	Sulfamethoxazole + MMX Mesalazine/Mesalamine First	21
First Intervention	NOT COMPLETED	Sulfamethoxazole + MMX Placebo First	0
First Intervention	NOT COMPLETED	Sulfamethoxazole + MMX Mesalazine/Mesalamine First	1
Second Intervention	STARTED	Sulfamethoxazole + MMX Placebo First	22
Second Intervention	STARTED	Sulfamethoxazole + MMX Mesalazine/Mesalamine First	21
Second Intervention	COMPLETED	Sulfamethoxazole + MMX Placebo First	21
Second Intervention	COMPLETED	Sulfamethoxazole + MMX Mesalazine/Mesalamine First	21

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events34

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Abdominal discomfort	Gastrointestinal disorders	Sulfamethoxazole + MMX Placebo	1	43	1
other	Abdominal discomfort	Gastrointestinal disorders	Sulfamethoxazole + MMX Mesalazine/Mesalamine	0	44	0
other	Abdominal distension	Gastrointestinal disorders	Sulfamethoxazole + MMX Placebo	0	43	0
other	Abdominal distension	Gastrointestinal disorders	Sulfamethoxazole + MMX Mesalazine/Mesalamine	1	44	1
other	Constipation	Gastrointestinal disorders	Sulfamethoxazole + MMX Placebo	1	43	1
other	Constipation	Gastrointestinal disorders	Sulfamethoxazole + MMX Mesalazine/Mesalamine	2	44	2
other	Diarrhea	Gastrointestinal disorders	Sulfamethoxazole + MMX Placebo	1	43	1
other	Diarrhea	Gastrointestinal disorders	Sulfamethoxazole + MMX Mesalazine/Mesalamine	1	44	1
other	Dry mouth	Gastrointestinal disorders	Sulfamethoxazole + MMX Placebo	0	43	0
other	Dry mouth	Gastrointestinal disorders	Sulfamethoxazole + MMX Mesalazine/Mesalamine	1	44	1

1 to 10 of 34Source ClinicalTrials.gov

See all 34 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Sulfamethoxazole + MMX Placebo
Total, all-cause mortality	Sulfamethoxazole + MMX Mesalazine/Mesalamine
Total, other adverse events	Sulfamethoxazole + MMX Placebo	10	43
Total, other adverse events	Sulfamethoxazole + MMX Mesalazine/Mesalamine	14	44
Total, serious adverse events	Sulfamethoxazole + MMX Placebo	0	43
Total, serious adverse events	Sulfamethoxazole + MMX Mesalazine/Mesalamine	0	44

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
24868146	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Sulfamethoxazole + MMX Placebo vs Sulfamethoxazole + MMX Mesalazine/Mesalamine: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01469637

GET https://conductscience.org/api/trials/v1/NCT01469637/events?page=2

API reference For AI assistants