A Phase 4 interventional study of linaclotide or placebo in Chronic Constipation and Diabete Mellitus, sponsored by Texas Tech University Health Sciences Center, El Paso. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-04-03.
Sponsored by Texas Tech University Health Sciences Center, El Paso · Phase 4, Interventional, and Treatment
Among 3,021 studies in Diabetes Mellitus with a site in United States — 288 open to participants now, 389 under way, 12 of them phase 3. Diabetes Mellitus · United States.
Among the 3,021 studies in Diabetes Mellitus with a site in United States, this one is the 1,978th largest by enrollment of the 2,500 interventional ones that give a count, is one of 107 that started in 2015, is one of 215 in phase 4, reaches primary completion later than 83 of the 381 other live ones, and was the 2,027th registered.
8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.
Browse Diabetes Mellitus studies →288 of the 3,021 studies in Diabetes Mellitus with a site in United States are open now. Recruiting first, the newest first:
Bettina Mittendorfer · Sites in United States
Ages 18–100 · Healthy volunteers
University of California, Los Angeles · Sites in United States
Ages 18+
Mayo Clinic · Sites in United States
Ages 18+
Pfizer · Sites in United States
Ages 18+
University of Colorado, Denver · Sites in United States
Ages 14–24
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 651 Diabetes Mellitus studies recruiting now, 357 (55%) set no upper age limit and 198 (30%) stop at 75 or younger; 87 take children under 18; 183 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
3,021 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 262 · Phase 2 371 · Phase 3 340 · Phase 4 215
First in 1976; this study’s year is marked. 107 started in 2015.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 23 is below the median of 80 across 6,023 interventional studies indexed under Diabetes Mellitus.
Median enrollment 82 across the 2,500 interventional studies, 159 across the 499 observational. Of the 2,396 that completed or were terminated, 987 (41%) have results posted.
This tab as a report to print or save as PDF → With an account.
852 of 3,021 have an industry lead sponsor. The 10 most frequent:
Texas Tech University Health Sciences Center, El Paso is the lead sponsor of 43 studies on the registry; 3 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
Texas Tech University Health Sciences Center, El Paso has 4 studies filed under Diabetes Mellitus — fewer than ten, so there is no comparison to draw.
141 of the studies in Diabetes Mellitus with a site in United States that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03982693Phase 3Mt. Sinai Medical Center, MiamiTrial to Assess Chelation Therapy in Critical Limb Ischemia | 2026-12 |
| NCT05174052Phase 3University of OklahomaDapagliflozin in Patients With Atrial Fibrillation (DAPA-AF) | 2027-04 |
| NCT02262832Phase 3National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Compassionate Use of Metreleptin in Previously Treated People With Generalized Lipodystrophy | 2027-07-31 |
| NCT07400653Phase 3PfizerA Study to Learn About the Study Medicine (PF-08653944) in People With Obesity or Overweight and Type 2 Diabetes (T2D) | 2027-10-12 |
| NCT07556354University of Alabama at BirminghamEmpowering Faith-based Communities to Provide Personalized Diabetes Self-management Education and Support (DSMES) in the Magic City | 2026-11 |
Among the 3,021 studies in Diabetes Mellitus with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Functional Constipation defined by Rome III criteria are as follows: a. At least a 6 months history of constipation.
b. 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.
d. Sensation of incomplete evacuation following at least 25% of bowel movements.
e. 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.
Exclusion Criteria:
Use of any of the following drugs within 3 days prior randomization and during the trial: a. Prokinetic agents (domperidone, metoclopramide, erythromycin).
b. Medication containing opiates. c. Anti-spasmodic (e.g. Atropine, hyoscamine, scopolamine, glycopyrrolate).
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: linaclotide or placebo
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.
Drug: linaclotide or placebo
Also known as: Linzess
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.
Time frame: Up to 10 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2015 (actual). Primary completion is estimated for Oct 2026, 133 months after the start.
Of 149 non-industry phase 4 interventional studies under Diabetes Mellitus, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 53. This study's planned 133 months is above that.
Counting every sponsor, half of 197 studies reached it within 24 months; a quarter within 13 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Texas Tech University Health Sciences Center, El Paso