Diabetic GastroparesisPhase 2NCT03342157
Docusate/Senna for the Treatment of Diabetic Gastroparesis
A Phase 2 study testing senna/docusate in people with Diabetic Gastroparesis, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The aim of the study is to evaluate the efficacy of the stimulant laxative Senokot-S® for the treatment of diabetic gastroparesis. Senokot-S, and its metabolites, are thought to produce peristalsis, drive intraluminal fluid and electrolyte shifts, and have an irritant effect on the gut mucosa. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Gastroparesis
- What is being tested?
- senna/docusate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2018to 17 Aug 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years, male and non-pregnant, non-lactating females
- Diagnosis of type 1 or type 2 diabetes mellitus
- Clinical diagnosis of diabetic gastroparesis
Who cannot join
- Diagnosed idiopathic gastroparesis
- A history or inflammatory bowel disease, such as Crohn's disease or ulcerative colitis
- A history of bowel obstruction, current unexplained abdominal pain, or undiagnosed rectal bleeding
- Gastrointestinal cancer
- Any active cancer
- Prior gastric surgery
Show all 11Show fewer
- End-stage heart disease, liver disease, lung disease
- Known or suspected drug abuse
- Any condition requiring use of daily narcotics
- Concurrent usage of mineral oil or products containing mineral oil
- Current or recent (within the last 3 months) usage of Senokot-S, docusate or senna
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study for the Efficacy and Tolerability of Senokot-S in the Treatment of Diabetic Gastroparesis
The aim of the study is to evaluate the efficacy of the stimulant laxative Senokot-S® for the treatment of diabetic gastroparesis. Senokot-S, and its metabolites, are thought to produce peristalsis, drive intraluminal fluid and electrolyte shifts, and have an irritant effect on the gut mucosa. These complex physiologic mechanisms appear may sufficiently promote stomach emp-tying, and thereby reduce or eliminate the severity of gastroparesis symptoms. In this open label study, participants will be randomized into high and low dose groups to assess for ideal dosing and tolerability. It is the overall goal of this study to select the most promising dose-strength for the treatment of mild through severe gastroparesis.
- Conditions
- Diabetic Gastroparesis
- Being tested
- senna/docusate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
senna/docusateDrug
Also called Senokot-S
Stimulant laxative
| Study group | Role | What they receive |
|---|---|---|
| High-dose | Experimental | 8.6/50 mg of senna/docusate, oral, twice daily Receives: Drug: senna/docusate |
| Low-dose | Experimental | 8.6/50 mg of senna/docusate, oral, once daily Receives: Drug: senna/docusate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Gastroparesis Cardinal Symptom Index-Daily Diary (mGCSI-DD)
mGCSI-DD uses 6-point Likert scale from 0 (none) to very severe (5)
Measured: 28 days
Secondary outcomes (2)
Frequency of Use of Breakthrough Medication
Change in the frequency of use of breakthrough medication - daily diary
Measured: 28 days
Frequency of Bowel Movements
Change in the frequency of bowel movements - daily diary
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start2 Apr 2018
- Primary completion17 Aug 2018
- Study completion17 Aug 2018
Why it stopped: low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetic GastroparesisStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bradley Gose, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03342157
- Sponsor's protocol ID
- 17.120
- Status last verified
- Sep 2020
- First submitted
- 10 Nov 2017
- Last updated
- 3 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for the Efficacy and Tolerability of Senokot-S in the Treatment of Diabetic Gastroparesis
- ClinicalTrials.gov ID
- NCT03342157
- Acronym / sponsor ID
- 17.120
- Conditions
- Diabetic Gastroparesis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 2 Apr 2018 (actual)
- Primary completion
- 17 Aug 2018 (actual)
- Study completion
- 17 Aug 2018 (actual)
- First posted
- 14 Nov 2017 (actual)
- Results
- Posted 23 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to evaluate the efficacy of the stimulant laxative Senokot-S® for the treatment of diabetic gastroparesis. Senokot-S, and its metabolites, are thought to produce peristalsis, drive intraluminal fluid and electrolyte shifts, and have an irritant effect on the gut mucosa. These complex physiologic mechanisms appear may sufficiently promote stomach emp-tying, and thereby reduce or eliminate the severity of gastroparesis symptoms. In this open label study, participants will be randomized into high and low dose groups to assess for ideal dosing and tolerability. It is the overall goal of this study to select the most promising dose-strength for the treatment of mild through severe gastroparesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-dose | Experimental | Drug: senna/docusate8.6/50 mg of senna/docusate, oral, twice daily |
| Low-dose | Experimental | Drug: senna/docusate8.6/50 mg of senna/docusate, oral, once daily |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-75 years, male and non-pregnant, non-lactating females
- Diagnosis of type 1 or type 2 diabetes mellitus
- Clinical diagnosis of diabetic gastroparesis
Key exclusion criteria (11 listed)
- Diagnosed idiopathic gastroparesis
- A history or inflammatory bowel disease, such as Crohn's disease or ulcerative colitis
- A history of bowel obstruction, current unexplained abdominal pain, or undiagnosed rectal bleeding
- Gastrointestinal cancer
- Any active cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| senna/docusateAlso: Senokot-SStimulant laxative | Drug | High-dose, Low-dose |
Primary outcome
Modified Gastroparesis Cardinal Symptom Index-Daily Diary (mGCSI-DD)
Time frame: 28 days
mGCSI-DD uses 6-point Likert scale from 0 (none) to very severe (5)
2 secondary outcomes
Frequency of Use of Breakthrough Medication
Time frame: 28 days
Frequency of Bowel Movements
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Diabetic Gastroparesis
Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
Motility Disorder, Gastroparesis
Recruiting
To Study the Efficacy and Safety of Medtronic 780G Insulin Pump in People With Gastroparesis and Type 1 Diabetes.
Type 1 Diabetes, Gastroparesis Due to Diabetes Mellitus Type I
Active, not recruiting
Impact of Per Oral Pyloromyotomy (POP) on Glycemic Control in Diabetes
Diabetes Mellitus, Gastroparesis With Diabetes Mellitus
Recruiting
Washed Microbiota Transplantation for Diabetic Gastroparesis
Diabetic Gastroparesis
Recruiting
Continuous Glucose Metrics in Patients With Gastroparesis in Type 1 or Type 2 Diabetes
Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bradley Gose, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing senna/docusate in people with Diabetic Gastroparesis, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Gastroparesis Cardinal Symptom Index-Daily Diary (mGCSI-DD) (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024.