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Trial Outcomes & Findings for Docusate/Senna for the Treatment of Diabetic Gastroparesis (NCT NCT03342157)

NCT ID: NCT03342157

Last Updated: 2024-10-03

Results Overview

mGCSI-DD uses 6-point Likert scale from 0 (none) to very severe (5)

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

28 days

Results posted on

2024-10-03

Participant Flow

Recruitment occurred from 11/01/2017 through 05/11/2020 at St Lukes Medical Center utilizing outpatient and inpatient referrals from practitioners.

No enrolled participants were excluded from the study.

Participant milestones

Participant milestones
Measure
High-dose
8.6/50 mg of senna/docusate, oral, twice daily senna/docusate: Stimulant laxative
Low-dose
8.6/50 mg of senna/docusate, oral, once daily senna/docusate: Stimulant laxative
Overall Study
STARTED
1
1
Overall Study
COMPLETED
1
1
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
High-dose
n=1 Participants
8.6/50 mg of senna/docusate, oral, twice daily senna/docusate: Stimulant laxative
Low-dose
n=1 Participants
8.6/50 mg of senna/docusate, oral, once daily senna/docusate: Stimulant laxative
Total
n=2 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=1 Participants
0 Participants
n=1 Participants
0 Participants
n=2 Participants
Age, Categorical
Between 18 and 65 years
1 Participants
n=1 Participants
1 Participants
n=1 Participants
2 Participants
n=2 Participants
Age, Categorical
>=65 years
0 Participants
n=1 Participants
0 Participants
n=1 Participants
0 Participants
n=2 Participants
Age, Continuous
51 years
n=1 Participants
49 years
n=1 Participants
50 years
n=2 Participants
Sex: Female, Male
Female
1 Participants
n=1 Participants
1 Participants
n=1 Participants
2 Participants
n=2 Participants
Sex: Female, Male
Male
0 Participants
n=1 Participants
0 Participants
n=1 Participants
0 Participants
n=2 Participants
Race and Ethnicity Not Collected
—
—
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
United States
1 Participants
n=1 Participants
1 Participants
n=1 Participants
2 Participants
n=2 Participants

PRIMARY outcome

Timeframe: 28 days

Population: Statistical analysis not appropriate on a sample size of 1 patient per arm.

mGCSI-DD uses 6-point Likert scale from 0 (none) to very severe (5)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 days

Population: Statistical analysis not appropriate on a sample size of 1 patient per arm.

Change in the frequency of use of breakthrough medication - daily diary

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 days

Population: Statistical analysis not appropriate on a sample size of 1 patient per arm.

Change in the frequency of bowel movements - daily diary

Outcome measures

Outcome data not reported

Adverse Events

Low-dose

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

High-dose

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Bradley Gose

Advocate Aurora Health

Phone: 414-385-2590

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place