Dose-Finding Trial of Polyethylene Glycol 3350 Laxative Plus Electrolytes for the Treatment of Constipation (Protocol P07515)

NCT01212445 | Completed Phase 2 Results

• 2 other identifiers: 181292010-021367-32
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study was to evaluate the proportion of subjects with a bowel movement (BM) without straining or without hard and/or lumpy stool within the first 24 h of treatment for subjects taking 1 of 3 single doses of Polyethylene Glycol (PEG) plus Electrolytes (PEG+E) (13.125 g, 26.25 g, 39.375 g). The doses specified relate to the doses of PEG. Secondary objectives were measured by analysis of a subject diary and self-reported BM data. The secondary objectives included comparisons of PEG+E doses at 24 h for: BM control; relief of gas; relief of bloating; and relief of abdominal discomfort/cramping. In addition, the proportion of subjects with a BM (without straining and without hard and/or lumpy stool) within the first 24 h of treatment for subjects taking different doses of PEG+E was evaluated for the time to first BM.

Conditions

Constipation

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Successful Bowel Movement (BM) Within 24 Hours of PEG + E Administration

  A successful BM was defined as a BM with no straining or hard/lumpy stools.

  From time of study drug treatment up to 24 hours

Secondary Outcomes (7)

• Number of Participants With Time To First Successful BM In 0 Days Through 0.5 Days, >0.5 Days Through 1.0 Days, or >1.0 Days Through 1.5 Days After PEG+E Administration

  From time of study drug administration up to 3 Days

• Percentage of Participants With Successful BM Within 12 Hours of PEG+E Administration

  From time of study drug treatment up to 12 hours

• Mean Visual Analog Scale (VAS) Rating for BM Control

  From time of study drug treatment up to 24 hours

• Mean VAS Rating for Gas

  From time of study drug treatment up to 24 hours

• Mean VAS Rating for Bloating

  From time of study drug treatment up to 24 hours

Study Arms (3)

PEG + E, 13.125 g

EXPERIMENTAL

Single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time

Drug: PEG 3350 laxative plus electrolytes (PEG + E)/Macrogol (Movicol®, BAY81-8430)

PEG + E, 26.25 g

EXPERIMENTAL

Two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time

Drug: PEG 3350 laxative plus electrolytes (PEG + E)/Macrogol (Movicol®, BAY81-8430)

PEG + E, 39.375 g

EXPERIMENTAL

Three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time

Drug: PEG 3350 laxative plus electrolytes (PEG + E)/Macrogol (Movicol®, BAY81-8430)

Interventions

PEG 3350 laxative plus electrolytes (PEG + E)/Macrogol (Movicol®, BAY81-8430) DRUG

13.125 g of PEG 3350 powder with approximately 0.6 g of electrolytes

PEG + E, 13.125 g; PEG + E, 26.25 g; PEG + E, 39.375 g

Eligibility Criteria

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

You may qualify if:

• A willingness to participate in the study and comply with its procedures
• Must be ambulatory
• Male or female subjects aged 18 years or older who met two or more of the following modified Rome III-based criteria for constipation: (a) straining during at least 25% of defecations; (b) lumpy or hard stools in at least 25% of defecations; (c) sensation of incomplete evacuation for at least 25% of defecation; (d) sensation of anorectal obstruction/blockage for at least 25% of defecations; (e) manual maneuvers to facilitate at least 25% of defecations (eg, digital evacuation, support of the pelvic floor), and (f) fewer than 3 defecations per week
• Criteria fulfilled for the last 3 months with symptom onset at least 6 mo prior to diagnosis
• Had a self reported or documented history of chronic constipation
• Agreed not to use laxatives other than the study treatment from baseline/informed consent to end-of-study
• Agreed to maintain a similar diet from the week before Visit 3 to the end-of-study were to be enrolled
• Additionally required not to use any treatment known to cause constipation during the study (for subjects enrolled after Amendment 1)
• If a female subject, either surgically sterile, 2 years postmenopausal, or using an acceptable method of contraception. Abstinence was not an acceptable method of contraception. Females of childbearing potential had to have a urine pregnancy test (human chorionic gonadotropin \[HCG\]) that was negative at Visit 3
• Be able to read and write in the diaries in English

You may not qualify if:

• Had loose stools without the use of laxatives
• Recurrent abdominal pain
• Known or suspected bowel perforation, obstruction, or fecal impaction; or had gastric retention, inflammatory bowel disease, bowel resection, or colostomy
• Celiac disease or known gluten sensitivity
• Known renal or hepatic insufficiency
• Recent history of alcohol abuse or drug abuse
• History of psychiatric disorders
• History of significant ongoing medical problems or scheduled for surgical procedures
• Subjects who, in the opinion of the Investigator, should not have been included in the study for any reason, including inability to follow study procedures
• Participated in an investigational clinical, surgical, drug or device study within the past 30 days
• Pregnant or lactating
• Allergic to PEG or PEG+E
• Employed by or have immediate family members employed by a company that manufactures laxative products
• Participant or family member of the Investigator or site staff directly involved with this study

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Cork, Ireland

Location

Related Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

MeSH Terms

Conditions

Constipation

Interventions

Electrolytes

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Inorganic Chemicals

Results Point of Contact

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

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Bayer Study Director

  Bayer

  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: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2010
• First Posted: September 30, 2010
• Study Start: October 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: March 15, 2016
• Results First Posted: March 11, 2013

Record last verified: 2016-02

Locations

IE (1)