Chronic ConstipationPhase 4NCT03119584
Efficacy of Linaclotide in Type II Diabetics With Chronic Constipation
A Phase 4 study of Chronic Constipation and Diabete Mellitus, run by Texas Tech University Health Sciences Center, El Paso at 1 site in United States.
Trial summary
Study includes 5 visits, when all basic clinical information, vital signs, symptoms, and side effects are going to be assessed at each appointment. Patients are going to be assigned by the computer, to receive an active or non-active drug for 14 days in a first phase. The order will be change during the second phase. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Constipation, Diabete Mellitus
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2015to Jan 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type II diabetics.
- Functional Constipation defined by Rome III criteria are as follows: a. At least a 6 months history of constipation.
- Less than three spontaneous bowel movements (SBMs) per week. c. At least 25% of stools are lumpy or hard stools as it is described in Bristol Stool Form Scale (BSFS) less than score of 6.
- Sensation of incomplete evacuation following at least 25% of bowel movements.
- Straining on at least 25% of defecations. f. Sensation of anorectal obstruction/blockage for at least 25% of defecations.
- Note: The above criteria are only applicable to spontaneous bowel movements. Patients who have no spontaneous bowel movements (bowel movements are preceded by laxative intake) are considered constipated and are eligible for this study.
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- For patients' ≥ 50 years of age, normal colonic anatomy as documented by colonoscopy or double-contrast barium enema, performed within the previous 5 years, based on the American Gastroenterological Association guidelines.
- Patients with confirm diagnosis of Diabetic Autonomic Neuropathy based on results of ANX 3.0, real-time ANS monitoring system will be included in this investigation.
- Patients diagnosed with diabetic peripheral neuropathy and/or symptoms of functional gastroduodenal disorders, such as GERD and functional dyspepsia may participate in a study.
Who cannot join
- Pregnancy or lactation
- Subjects unwilling to practice adequate contraception throughout the period of screening through 14 days after study termination.
- Loose or watery stools reported in the absence of laxatives for >25% of BMs during the screening period by using Bristol Stool Form Scale (BSFS).
- Use of laxatives 3 days immediately prior to randomization (except fiber or bulking agents) and chronic laxative use during the trial.
- Patients diagnosed with severe, drug refractory gastroparesis (persistent daily vomiting), currently receiving parenteral feeding (N-G, J-G-Tubes), having history of frequent hospitalizations, or being implanted with gastric neurostimulation system.
- Use of any of the following drugs within 3 days prior randomization and during the trial: a. Prokinetic agents (domperidone, metoclopramide, erythromycin).
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- Medication containing opiates. c. Anti-spasmodic (e.g. Atropine, hyoscamine, scopolamine, glycopyrrolate).
- Hemoglobin A1c>8.2
- Use of illegal drugs.
- Regular consumption of more than 2 drinks of alcohol per day
- Chronic, more than 3/week use of NSAIDs.
- Patients with prolonged straining/push during BMs suggesting severe pelvic floor dysfunction.
- History or current diagnosis of diverticulitis and severe hemorrhoids.
- History of gastric resections, partial colon resection, history of rectocele.
- Existence of any major medical condition such as malignancy, severe renal and liver diseases, which in the decision of PI should be excluded from participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Tech University Health Sciences Center
El Paso, Texas, 79905
About this study
Official title: Efficacy of Linaclotide in Type II Diabetics With Chronic Constipation: A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Trial
Study includes 5 visits, when all basic clinical information, vital signs, symptoms, and side effects are going to be assessed at each appointment.
Patients are going to be assigned by the computer, to receive an active or non-active drug for 14 days in a first phase. The order will be change during the second phase. The 2 weeks break without our medication will separate these phases. A very close observation regarding safety of our subjects will be implemented by study personnel and clinical investigators.
Read the detailed description
The symptoms of chronic constipation are defined as infrequent bowel movements, hard stool, straining during defecation, bloating, abdominal discomfort, and sensation of incomplete evacuation.
Constipation has been reported as a common complication of diabetic neuropathy. A new medication, called linaclotide, was studied on many patients, and it is approved to be on a market for constipated patients. Unfortunately diabetics were not included in these previous studies; hence we designed the project which is going to address the possible benefit of this drug in diabetic population.
- Conditions
- Chronic Constipation, Diabete Mellitus
- Being tested
- linaclotide or placebo
- Keywords
- chronic constipation, diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
linaclotide or placeboDrug
Also called Linzess
| Study group | Role | What they receive |
|---|---|---|
| 1)28days of linaclotide or placebo | Active comparator | patient will be randomized and allocated to one of the treatment arms using computerized generated simple random number in a double-blinded fashion for 28 days of therapy with the study drug, linaclotide or placebo. Patients, and trial personnel involve (other than biostatistician) in this study will not be aware of the group assignments. Patients, treatment providers and staffs will be kept blinded in this study. Receives: Drug: linaclotide or placebo |
| 2)28days of linaclotide or placebo | Active comparator | patient will be randomized and allocated to one of the treatment arms using computerized generated simple random number in a double-blinded fashion for 28 days of therapy with the study drug, linaclotide or placebo. Patients, and trial personnel involve (other than biostatistician) in this study will not be aware of the group assignments. Patients, treatment providers and staffs will be kept blinded in this study. Receives: Drug: linaclotide or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in frequency of bowel movements
The primary outcome measure will indicate improvement in frequency of bowel movements (BMs) or not in a mean of available and recordered spontaneous BM (SBMs) over the 28 day treatment period compared to 28 days of placebo.
Measured: Up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start1 Sep 2015
- Primary completionOct 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic ConstipationStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center, El Paso
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irene Sarosiek, Texas Tech University Health Sciences Center, El Paso
- Investigators
- Irene Sarosiek, MD, Principal investigator, Texas Tech University Health Sciences Center- El Paso, Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03119584
- Sponsor's protocol ID
- E15025
- Status last verified
- Mar 2026
- First submitted
- 13 Apr 2017
- Last updated
- 3 Apr 2026
- Results posted
- No
- 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 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Linaclotide in Type II Diabetics With Chronic Constipation: A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Trial
- ClinicalTrials.gov ID
- NCT03119584
- Acronym / sponsor ID
- E15025
- Conditions
- Chronic Constipation, Diabete Mellitus
- Keywords
- chronic constipation, diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences Center, El PasoUniversity, hospital or other
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 18 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study includes 5 visits, when all basic clinical information, vital signs, symptoms, and side effects are going to be assessed at each appointment.
Patients are going to be assigned by the computer, to receive an active or non-active drug for 14 days in a first phase. The order will be change during the second phase. The 2 weeks break without our medication will separate these phases. A very close observation regarding safety of our subjects will be implemented by study personnel and clinical investigators.
Detailed description
The symptoms of chronic constipation are defined as infrequent bowel movements, hard stool, straining during defecation, bloating, abdominal discomfort, and sensation of incomplete evacuation.
Constipation has been reported as a common complication of diabetic neuropathy. A new medication, called linaclotide, was studied on many patients, and it is approved to be on a market for constipated patients. Unfortunately diabetics were not included in these previous studies; hence we designed the project which is going to address the possible benefit of this drug in diabetic population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1)28days of linaclotide or placebo | Active comparator | Drug: linaclotide or placebopatient will be randomized and allocated to one of the treatment arms using computerized generated simple random number in a double-blinded fashion for 28 days of therapy with the study drug, linaclotide or placebo. Patients, and trial personnel involve (other than biostatistician) in this study will not be aware of the group assignments. Patients, treatment providers and staffs will be kept blinded in this study. |
| 2)28days of linaclotide or placebo | Active comparator | Drug: linaclotide or placebopatient will be randomized and allocated to one of the treatment arms using computerized generated simple random number in a double-blinded fashion for 28 days of therapy with the study drug, linaclotide or placebo. Patients, and trial personnel involve (other than biostatistician) in this study will not be aware of the group assignments. Patients, treatment providers and staffs will be kept blinded in this study. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Type II diabetics.
- Functional Constipation defined by Rome III criteria are as follows: a. At least a 6 months history of constipation.
- Note: The above criteria are only applicable to spontaneous bowel movements. Patients who have no spontaneous bowel movements (bowel movements are preceded by laxative intake) are considered constipated and are eligible for this study.
- For patients' ≥ 50 years of age, normal colonic anatomy as documented by colonoscopy or double-contrast barium enema, performed within the previous 5 years, based on the American Gastroenterological Association guidelines.
- Patients with confirm diagnosis of Diabetic Autonomic Neuropathy based on results of ANX 3.0, real-time ANS monitoring system will be included in this investigation.
Key exclusion criteria (15 listed)
- Pregnancy or lactation
- Subjects unwilling to practice adequate contraception throughout the period of screening through 14 days after study termination.
- Loose or watery stools reported in the absence of laxatives for >25% of BMs during the screening period by using Bristol Stool Form Scale (BSFS).
- Use of laxatives 3 days immediately prior to randomization (except fiber or bulking agents) and chronic laxative use during the trial.
- Patients diagnosed with severe, drug refractory gastroparesis (persistent daily vomiting), currently receiving parenteral feeding (N-G, J-G-Tubes), having history of frequent hospitalizations, or being implanted with gastric neurostimulation system.
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 |
|---|---|---|
| linaclotide or placeboAlso: Linzess | Drug | 1)28days of linaclotide or placebo, 2)28days of linaclotide or placebo |
Primary outcome
Improvement in frequency of bowel movements
Time frame: Up to 10 weeks
The primary outcome measure will indicate improvement in frequency of bowel movements (BMs) or not in a mean of available and recordered spontaneous BM (SBMs) over the 28 day treatment period compared to 28 days of placebo.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Irene Sarosiek, MD principal investigator
Texas Tech University Health Sciences Center- El Paso, Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Chronic Constipation and Diabete Mellitus, run by Texas Tech University Health Sciences Center, El Paso 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 9 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 3 Apr 2026. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Improvement in frequency of bowel movements (time frame: Up to 10 weeks). 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 Apr 2026.