Status:
COMPLETED
Safety and Tolerability of Oral Polyethylene Glycol (PEG 3350) Solution in Participants With Constipation (MK-8114-003)
Lead Sponsor:
Bayer
Conditions:
Constipation
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 constip...
Detailed Description
This was a randomized, single-blind, placebo-controlled study to evaluate the proportion of participants with abnormalities of the oral mucosa detected by visual examination of the oral cavity in the ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT01885104
Start Date
April 1 2013
End Date
October 1 2013
Last Update
March 11 2015
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