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

NCT01885104 | Completed Phase 2 Results

• 3 other identifiers: 18127CL2012-138114-003
• Study Type: interventional
• Target: 65
• Locations: 0 countries
• Sites: N/A

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 constipation.

Conditions

Constipation

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Inflammation of the Oral Mucosa

  Participants underwent visual examination of the oral muscosa at Visit 2 and Visit 3. Measurements were based on 0-3 Likert Scale Scores: 0 = No inflammation (no erythema, no erosion/ulceration); 1 = Mild inflammation (erythema without erosion/ulceration); 2 = Moderate inflammation (erythema with erosion); 3 = Severe inflammation (erythema with ulceration).

  Visit 2 (Day 1) and Visit 3 (Day 17 ± 2 days), up to 19 days after start of treatment

• Number of Participants With Inflammation of the Esophageal Mucosa

  Participants underwent endoscopic examination of the esophageal mucosa at Visit 2 and Visit 3. Measurements were based on 0-3 Likert Scale Scores: 0 = No inflammation (no erythema, no erosion/ulceration); 1 = Mild inflammation (erythema without erosion/ulceration); 2 = Moderate inflammation (erythema with erosion); 3 = Severe inflammation (erythema with ulceration).

  Visit 2 (Day 1) and Visit 3 (Day 17 ± 2 days), up to 19 days after start of treatment

Study Arms (2)

PEG 3350

EXPERIMENTAL

Participants will receive a 17 g dose of PEG 3350 solution concentrate in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, will be provided for use as a rescue medication if a participant has not had a bowel movement for 72 hours after start of treatment.

Drug: Polyethylene Glycol (PEG 3350); Drug: Bisacodyl laxative tablets (rescue medication)

Placebo

PLACEBO COMPARATOR

Participants will receive a 17 g dose of Placebo solution concentrate in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, will be provided for use as a rescue medication if a participant has not had a bowel movement for 72 hours after start of treatment.

Drug: Placebo; Drug: Bisacodyl laxative tablets (rescue medication)

Interventions

Polyethylene Glycol (PEG 3350) DRUG

Oral 17 g dose of PEG 3350 solution concentrate in a volume of approximately 30 mL, once a day, for 14 days.

Also known as: MiraLAX Solution Concentrate

PEG 3350

Placebo DRUG

Oral 17 g dose of Placebo solution concentrate in a volume of approximately 30 mL, once a day, for 14 days.

Placebo

Bisacodyl laxative tablets (rescue medication) DRUG

5.0 mg tablets, 1 to 3 tablets in a single daily dose, to be provided for use as rescue medication if participant has not had bowel movement for 72 hours after start of treatment.

PEG 3350; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Related Publications (1)

• McGraw T. Safety of polyethylene glycol 3350 solution in chronic constipation: randomized, placebo-controlled trial. Clin Exp Gastroenterol. 2016 Jul 15;9:173-80. doi: 10.2147/CEG.S111693. eCollection 2016.

  PMID: 27486340 DERIVED

MeSH Terms

Conditions

Constipation

Interventions

Polyethylene Glycols; polyethylene glycol 3350

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharpe & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2013
• First Posted: June 24, 2013
• Study Start: April 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: October 1, 2013
• Last Updated: March 11, 2015
• Results First Posted: September 25, 2014

Record last verified: 2015-02