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

NCT ID: NCT01212445

Last Updated: 2016-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2011-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PEG + E, 13.125 g

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

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

PEG + E, 26.25 g

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

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

PEG + E, 39.375 g

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

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

Interventions

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

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Cork, , Ireland

Countries

Ireland

Related Links

http://www.clinicaltrialsregister.eu/

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

Other Identifiers

2010-021367-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

18129

Identifier Type: -

Identifier Source: org_study_id