A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adolescent Subjects

Inclusion Criteria:

- Male or female subjects at between 12-17 years of age

- Weight more than 40 kg (88 lbs.).

- Constipated, defined by the following criteria

1. 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

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

3. There are insufficient criteria for irritable bowel syndrome - 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 12 weeks 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 (hormonal birth control, intrauterine device, double-barrier method, depot
contraceptive, sterilized, or abstinence)

- 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 3

- 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 the study medication

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

- 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