A Study of MD-7246 to Treat Abdominal Pain in Patients Wi... | NCT03931785

Status Module

Name	Class
Allergan Sales, LLC	INDUSTRY

Label	Type	Description	Intervention Names
MD-7246 300 μg	Experimental	1 MD-7246 300-μg oral tablet and 3 matching placebo oral tablets	Drug: MD-7246 Drug: Placebo
MD-7246 600 μg	Experimental	2 MD-7246 300-μg oral tablets and 2 matching placebo oral tablets	Drug: MD-7246 Drug: Placebo
MD-7246 1200 μg	Experimental	4 MD-7246 300-μg oral tablets	Drug: MD-7246
Placebo	Placebo Comparator	4 matching placebo oral tablets	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
MD-7246	Drug	Oral tablet	MD-7246 1200 μg MD-7246 300 μg MD-7246 600 μg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Abdominal Pain at Its Worst on a NRS Through the Treatment Period	Abdominal pain is measured daily in an eDiary, using an 11-point NRS, where 0 is anchored with "no abdominal pain" and 10 is anchored with "worst possible abdominal pain." The postbaseline weekly abdominal pain score is the average of the non-missing daily abdominal pain at its worst scores during a week (Weeks 1-12) if there are at least 4 daily scores entered into the eDiary during the week. Weekly change from baseline was calculated for each week as the weekly score minus the baseline score. Mixed model repeated measures (MMRM) results are based on a repeated measures analysis with treatment, analysis week, and treatment-by-week interaction as fixed effects and baseline as covariate. An unstructured covariance structure was used to model intra-subject correlation with subjects as a random effect. Baseline is derived from the eDiary data collected daily in the Pretreatment Period, specifically the period of time from 14 days before randomization up to the time of randomization.	Baseline, up to Week 12 (end of the Treatment Period)
Percentage of Participants Who Were 6/12 Week Abdominal Pain 30% Change Responders	A 6/12 Week Abdominal Pain 30% Responder was a participant who had a decrease from baseline of ≥30% in the weekly abdominal pain score for that week for at least 6 out of the 12 weeks of the Treatment Period; for any week, a participant with < 4 daily abdominal pain scores available was considered a non-responder for that week. Abdominal pain is measured daily in an eDiary, using an 11-point NRS, where 0 is anchored with "no abdominal pain" and 10 is anchored with "worst possible abdominal pain." The postbaseline weekly abdominal pain score is the average of the non-missing daily abdominal pain at its worst scores during a week (Weeks 1-12) if there are at least 4 daily scores entered into the eDiary during the week.	Baseline through Week 12

Eligibility Module

Name	Affiliation	Role
Wilmin Bartolini, PhD	Ironwood Pharmaceuticals, Inc.	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Research Associates		Huntsville	Alabama	35801	United States
Elite Clinical Studies

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	4 matching placebo oral tablets once daily (QD) for 12 weeks
FG001	MD-7246 300 μg	1 MD-7246 300-μg oral tablet and 3 matching placebo oral tablets QD for 12 weeks

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 29, 2019	Feb 19, 2021

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00043.4± 13.12 BG00145.0± 14.04 BG00242.2± 14.38 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00066 BG00163 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00024 BG00123 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Caucasian

Title	Measurements
	BG00072 BG00169 BG002

Abdominal Pain at Its Worst at Each Week on a Numerical Rating Scale (NRS)

Abdominal pain is measured daily in an electronic diary (eDiary), using an 11-point NRS, where 0 is anchored with "no abdominal pain" and 10 is anchored with "worst possible abdominal pain." Baseline is derived from the eDiary data collected daily in the Pretreatment Period, specifically the period of time from 14 days before randomization up to the time of randomization.

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG0006.22± 1.236 BG001

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline in Abdominal Pain at Its Worst on a NRS Through the Treatment Period

Abdominal pain is measured daily in an eDiary, using an 11-point NRS, where 0 is anchored with "no abdominal pain" and 10 is anchored with "worst possible abdominal pain." The postbaseline weekly abdominal pain score is the average of the non-missing daily abdominal pain at its worst scores during a week (Weeks 1-12) if there are at least 4 daily scores entered into the eDiary during the week. Weekly change from baseline was calculated for each week as the weekly score minus the baseline score.

Mixed model repeated measures (MMRM) results are based on a repeated measures analysis with treatment, analysis week, and treatment-by-week interaction as fixed effects and baseline as covariate. An unstructured covariance structure was used to model intra-subject correlation with subjects as a random effect.

Baseline is derived from the eDiary data collected daily in the Pretreatment Period, specifically the period of time from 14 days before randomization up to the time of randomization.

Modified Intent-to-Treat (mITT) Population: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at Baseline and during the treatment period.

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline, up to Week 12 (end of the Treatment Period)

ID	Title	Description
OG000	Placebo	4 matching placebo oral tablets once daily (QD) for 12 weeks
OG001	MD-7246 300 μg	1 MD-7246 300-μg oral tablet and 3 matching placebo oral tablets QD for 12 weeks
OG002	MD-7246 600 μg	2 MD-7246 300-μg oral tablets and 2 matching placebo oral tablets QD for 12 weeks
OG003	MD-7246 1200 μg	4 MD-7246 300-μg oral tablets QD for 12 weeks

Units	Counts
Participants	OG00097 OG00197 OG00297 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-2.01± 0.179 OG001-1.93± 0.179 OG002-1.58± 0.182 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		MMRM		0.7467		Least squares (LS) mean difference	0.08			2-Sided	95	-0.42	0.58			MD-7246 minus placebo		Superiority
OG000 OG002		MMRM

Primary

Percentage of Participants Who Were 6/12 Week Abdominal Pain 30% Change Responders

A 6/12 Week Abdominal Pain 30% Responder was a participant who had a decrease from baseline of ≥30% in the weekly abdominal pain score for that week for at least 6 out of the 12 weeks of the Treatment Period; for any week, a participant with < 4 daily abdominal pain scores available was considered a non-responder for that week.

Modified Intent-to-Treat (mITT) Population: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at Baseline and during the treatment period.

Posted

Number

percentage of participants

Baseline through Week 12

ID	Title	Description
OG000	Placebo	4 matching placebo oral tablets once daily (QD) for 12 weeks
OG001	MD-7246 300 μg	1 MD-7246 300-μg oral tablet and 3 matching placebo oral tablets QD for 12 weeks
OG002	MD-7246 600 μg

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0004 affected97 at risk EG0015 affected97 at risk EG0025 affected97 at risk EG0033 affected97 at risk
Headache	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected97 at risk EG0014 affected97 at risk EG0024 affected97 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected97 at risk EG0013 affected97 at risk EG0023 affected97 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0007 affected97 at risk EG0011 affected97 at risk EG0023 affected97 at risk EG003
Influenza	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected97 at risk EG0011 affected97 at risk EG0021 affected97 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected97 at risk EG0011 affected97 at risk EG0023 affected97 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected97 at risk EG0010 affected97 at risk EG0024 affected97 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected97 at risk EG0011 affected97 at risk EG0022 affected97 at risk EG003
Sinusitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected97 at risk EG0011 affected97 at risk EG0020 affected97 at risk EG003
Dizziness	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected97 at risk EG0010 affected97 at risk EG0021 affected97 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected97 at risk EG0012 affected97 at risk EG0021 affected97 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0003 affected97 at risk EG0011 affected97 at risk EG0022 affected97 at risk EG003
Vulvovaginal mycotic infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected97 at risk EG0010 affected97 at risk EG0022 affected97 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected97 at risk EG0012 affected97 at risk EG0020 affected97 at risk EG003
Bronchitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected97 at risk EG0010 affected97 at risk EG0021 affected97 at risk EG003
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected97 at risk EG0012 affected97 at risk EG0020 affected97 at risk EG003
Fatigue	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected97 at risk EG0010 affected97 at risk EG0022 affected97 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected97 at risk EG0012 affected97 at risk EG0021 affected97 at risk EG003
Hypertension	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected97 at risk EG0012 affected97 at risk EG0021 affected97 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected97 at risk EG0010 affected97 at risk EG0022 affected97 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 affected97 at risk EG0010 affected97 at risk EG0022 affected97 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected97 at risk EG0010 affected97 at risk EG0022 affected97 at risk EG003
Bacterial vaginosis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected97 at risk EG0010 affected97 at risk EG0020 affected97 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected97 at risk EG0010 affected97 at risk EG0020 affected97 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected97 at risk EG0010 affected97 at risk EG0020 affected97 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected97 at risk EG0010 affected97 at risk EG0020 affected97 at risk EG003

ID	Term
D015746	Abdominal Pain
D003967	Diarrhea
D043183	Irritable Bowel Syndrome

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D012817	Signs and Symptoms, Digestive
D003109	Colonic Diseases, Functional
D003108	Colonic Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

ID	Title	Description
BG000	Placebo	4 matching placebo oral tablets once daily (QD) for 12 weeks
BG001	MD-7246 300 μg	1 MD-7246 300-μg oral tablet and 3 matching placebo oral tablets QD for 12 weeks
BG002	MD-7246 600 μg	2 MD-7246 300-μg oral tablets and 2 matching placebo oral tablets QD for 12 weeks
BG003	MD-7246 1200 μg	4 MD-7246 300-μg oral tablets QD for 12 weeks
BG004	Total	Total of all reporting groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	4 matching placebo oral tablets once daily (QD) for 12 weeks	97	0	97	27	97
EG001	MD-7246 300 μg	1 MD-7246 300-μg oral tablet and 3 matching placebo oral tablets QD for 12 weeks	97	0	97	28	97
EG002	MD-7246 600 μg	2 MD-7246 300-μg oral tablets and 2 matching placebo oral tablets QD for 12 weeks	97	0	97	42	97
EG003	MD-7246 1200 μg	4 MD-7246 300-μg oral tablets QD for 12 weeks	97	1	97	52	97