A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults



Status:Completed
Conditions:Constipation
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:2/1/2017
Start Date:May 2015
End Date:November 2015

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The purpose of this study is to evaluate a daily dose of BLI400 Laxative for safety and
efficacy versus lubiprostone in constipated adults.


Inclusion Criteria:

- Male or female subjects at least 18 years of age

- Constipated, defined by the following adapted ROME II definition:

A. Fewer than 3 spontaneous defecations per week and at least one of the following
symptoms for at least 12 weeks (which need not be consecutive) in the preceding 12 months:

1. Straining during > 25% of defecations

2. Lumpy or hard stools in > 25% of defecations

3. Sensation of incomplete evacuation for > 25% of defecations

B. Loose stools are rarely present without the use of laxatives

C. There are insufficient criteria for IBS - loose (mushy) or watery stool in the absence
of laxative use for more than 25% of bowel movements

Criteria A, B and C must be fulfilled for the last 3 months with symptom onset at least 6
months prior to diagnosis.

- Otherwise in good health, as determined by physical exam and medical history

- If female, and of child-bearing potential, is using an acceptable form of birth
control

- Negative urine pregnancy test at screening, if applicable

- In the Investigator's judgment, subject is mentally competent to provide informed
consent to participate in the study

Exclusion Criteria:

- Subjects with known or suspected ileus, gastrointestinal obstruction, gastric
retention, bowel perforation, toxic colitis, toxic megacolon

- Subjects who have had major surgery 30 days before Visit 1; appendectomy or
cholecystectomy 60 days before Visit 1; abdominal, pelvic, or retroperitoneal surgery
6 months before Visit 1; bariatric surgery or surgery to remove a segment of the GI
tract at any time before Visit 1

- Subjects with hypothyroidism that is being treated and for which the dose of thyroid
hormone has not been stable for at least 6 weeks at the time of Visit 1

- Subjects taking laxatives, enemas or prokinetic agents that refuse to discontinue
these treatments from Visit 1 until after completion of Visit 5

- Subjects who are pregnant or lactating, or intend to become pregnant during the study

- Subjects of childbearing potential who refuse a pregnancy test

- Subjects who are allergic to any study medication component

- Subjects taking narcotic analgesics or other medications known to cause constipation

- Subjects with clinically significant cardiac abnormalities identified at the Visit 1
ECG

- Subjects who, in the opinion of the Investigator, should not be included in the study
for any reason, including inability to follow study procedures

- Subjects who have participated in an investigational clinical, surgical, drug, or
device study within the past 30 days

- Subjects with an active history of drug or alcohol abuse

- Subjects have been hospitalized for a psychiatric condition or have made a suicide
attempt during the 2 years before Visit 1

- Subjects who withdraw consent at any time prior to completion of Visit 1 procedures

- Subjects with known or suspected moderate to severe hepatic insufficiency (Child Pugh
Classes B and C)
We found this trial at
50
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Austin, Texas 78731
1065
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Anaheim, California 92801
1960
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Artesia, California 90701
1968
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Atlanta, Georgia 30328
436
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Austin, Texas 78731
1065
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Brandon, Florida 33511
832
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Brandon, Florida 33511
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Carrolton, Texas 75010
907
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Channelview, Texas 77530
980
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Charlottesville, Virginia 22911
280
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Chattanooga, Tennessee 37421
359
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Chicago, Illinois 60602
274
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Cincinnati, Ohio 45231
94
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Clearwater, Florida 33756
830
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Corona, California 92879
1939
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DeLand, Florida 32720
761
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Hialeah, Florida 33012
987
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Hialeah, Florida 33012
987
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Knoxville, Tennessee 37938
270
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La Mirada, California 90638
1963
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Laguna Hill, California 92653
1955
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Las Vegas, Nevada 89103
1756
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Memphis, Tennessee 38119
503
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Miami, Florida 33144
993
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Miami, Florida 33144
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Miami, Florida 33144
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Miami, Florida 33144
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Miami Lakes, Florida 33016
983
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Miami Springs, Florida 33166
989
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Mobile, Alabama 36688
699
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Monroe, Louisiana 71201
721
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Nashville, Tennessee 37012
332
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New York, New York 10016
442
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Newport News, Virginia 23606
404
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Orange, California 92868
1959
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Orlando, Florida 32801
795
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Orlando, Florida 32801
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Owensboro, Kentucky 42303
267
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Palmetto Bay, Florida 33157
1003
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Plano, Texas 75024
899
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Raleigh, North Carolina 27609
375
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Richland, Washington 99352
1862
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Sacramento, California 95821
2037
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San Diego, California 92103
1951
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Snellville, Georgia 30078
425
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St Petersburg, Florida 33709
839
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Tampa, Florida 33607
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Tucson, Arizona 85712
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West Monroe, Louisiana 71291
722
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West Palm Beach, Florida 33409
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