| Trial ID: | L4971 |
| Source ID: | NCT03119584
|
| Associated Drug: |
Linaclotide Or Placebo
|
| Title: |
Efficacy of Linaclotide in Type II Diabetics With Chronic Constipation
|
| Acronym: |
|
| Status: |
ACTIVE_NOT_RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Constipation|Diabete Mellitus
|
| Interventions: |
DRUG: linaclotide or placebo
|
| Outcome Measures: |
Primary: 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., Up to 10 weeks |
|
| Sponsor/Collaborators: |
Sponsor: Texas Tech University Health Sciences Center, El Paso
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
23
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2015-09-01
|
| Completion Date: |
2025-01-30
|
| Results First Posted: |
|
| Last Update Posted: |
2024-02-14
|
| Locations: |
Texas Tech University Health Sciences Center, El Paso, Texas, 79905, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03119584
|
