Summary:
Efficacy of Linaclotide in Type II Diabetics with Chronic
Constipation:
A Randomized, Double- Blind, Placebo- Controlled, and Cross- Over Trail
Purpose of this study
The main purpose of this study is to find out if 4 weeks of treatment with Linaclotide (study drug) will help your symptoms of chronic constipation as compared with 4 weeks duration with a placebo (non-active drug) in patients diagnosed with Type II Diabetes.
Inclusion criteria
Ages 18-70 men and women
Type II diabetics
At least 6 month history of constipation
Exclusion criteria
- Pregnant/ lactating
- Diarrhea
- Use of laxatives 3 days immediately prior to randomization
- Use of illegal drugs
- History or current diagnosis of diverticulitis and sever hemorrhoids
- History of gastric resections, partial colon resection, history of rectocele
- Existence of any major medical condition such as malignancy, severe renal and liver disease.
Study Duration- totally up to 3 months
- Up to 3 weeks of screening prior to randomization
- 8 weeks of treatment starting at randomization
- 2 weeks of washout period, where not medication is taken between treatment phases
Benefits
It is anticipated that by using the study drug it may benefit diabetic patients with chronic constipation. Many other patients who suffer with similar infrequent bowel movements as a complication of their diabetes could be helped with Linaclotide treatment also.
There is a possible compensation for your time and travel.