Safety and Tolerability of Oral Polyethylene Glycol (PEG 3350) Solution in Participants With Constipation (MK-8114-003)



Status:Completed
Conditions:Constipation
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:10/3/2013
Start Date:April 2013
End Date:September 2013
Contact:Toll Free Number
Phone:1-888-577-8839

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Evaluation of Oral Tolerance MiraLAX Solution Concentrate in Subjects With Chronic Constipation


The purpose of this study is to compare the safety and tolerability of oral ingestion of PEG
3350 solution concentrate to oral ingestion of a placebo solution concentrate, in
participants with constipation.


Inclusion Criteria:

- ambulatory male or female with no history or current evidence of other conditions or
abnormalities that would affect study results or interfere with participation for
full duration of study

- meets diagnostic criteria for functional constipation. This includes loose stools
that are rarely present without the use of laxatives and 2 or more of the following:
straining during at least 25% of defecations; lumpy or hard stools in at least 25% of
defecations; sensation of incomplete evacuation for at least 25% of defecations;
sensation of anorectal obstruction/blockage for at least 25% of defecations; manual
maneuvers to facilitate at least 25% of defecations [e.g., digital evacuation,
support of the pelvic floor]; and fewer than 3 defecations per week. Criteria for
functional constipation must be fulfilled for last 3 months, with symptom onset at
least 6 months prior to diagnosis.

- continuous or recurrent symptoms for at least 3 months of: abdominal pain or
discomfort, relieved with defecation, or associated with a change in frequency or
consistency of stool, and an irregular pattern of defecation at least 25% of the time
with 3 or more of the following: altered stool frequency, altered stool form (hard or
loose/watery), altered stool passage (straining or urgency, feeling of incomplete
evacuation), passage of mucus, and bloating or abdominal distension

- agrees to not use laxatives other than study medication for the duration of the study
period

- agrees to not use disallowed concomitant medications for the duration of the study

- agrees to maintain a similar diet and level of activity from the period of the
Screening Visit through End of Study

- individuals of reproductive potential must agree to remain abstinent or use (or have
their partner use) 2 acceptable methods of birth control and until 2 weeks after the
last dose of study drug in the last treatment period. Acceptable methods of birth
control include: intrauterine device (IUD), diaphragm with spermicide, contraceptive
sponge, condom, or vasectomy.

Exclusion Criteria:

- abnormal baseline endoscopy and/or an oral exam

- baseline oral exam showing evidence of oral lesions, such as herpes labialis or
aphthous stomatitis, or known self-reported history or current periodontal gum
disease

- history of impaired swallowing or difficulties swallowing foods and liquids

- known, history of, or suspected gastrointenstinal disease, including bowel
perforation, obstruction, fecal impaction; irritable bowel syndrome (IBS), delayed
gastric emptying, gastroparesis, gastroesophageal reflux disease (GERD), gastritis or
peptic ulcer disease (PUD), dehydration, inflammatory bowel disease, bowel resection,
anal fistulas/fissures, colostomy, etc.

- severe or unexplained abdominal pain

- history of or current alcohol or drug abuse

- history of malignancy ≤5 years prior to signing the informed consent, except for
adequately treated basal cell and/or squamous cell skin cancer or in situ cervical
cancer

- history of psychiatric illness requiring medications or hospitalization within the
previous 12 months

- history of concurrent illness that required hospitalization within 4 weeks prior to
Day -1 of the study

- allergies or allergic reactions or intolerance to any of the products used in study

- any degree of renal impairment

- major surgery or clinically significant illness within 4 weeks prior to Day -1 of
Visit 1

- current or recent (within the past 30 days of signing informed consent)
participation in a study with an investigational compound or device

- refusal to agree not to donate eggs or sperm upon the first study drug administration
and thereafter through 90 days after the last study drug administration

- individual is an employee or family member of an employee of the sponsor or clinical
unit where study will be conducted
We found this trial at
3
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Madison, WI
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