Efficacy and Safety of Polyethylene Glycol 3350 (PEG 3350) for Relief of Constipation (MK-8114-005)

July 15, 2015 updated by: Bayer

A Multicenter, Open Label, Non-controlled Phase 3 Clinical Trial of the Efficacy and the Safety for the Relief of Constipation of Polyethylene Glycol 3350

The purpose of this study is to evaluate the complete resolution of constipation in participants taking PEG 3350 compared to those taking PEG 4000, based on analysis of the number of bowel movements from self-reported bowel movement (BM) data. The complete resolution of constipation is defined as the elimination of straining or of hard/lumpy stools.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.
  • willing to use study drug for up to 7 days as directed, and must agree to record bowel movements (frequency, consistency, etc.) accurately and consistently in a daily diary, and make 3 clinic visits.
  • except for constipation, must be otherwise in good health, as determined by physical exam and medical history.
  • agrees not to use any other products (drug, herbal, dietary supplements including fiber, etc.) to treat their constipation during the course of the study.
  • agrees not to use any medication known to cause constipation during the course of the study.
  • agree to maintain a similar diet from the week prior to randomization through the end of the study.
  • females must be either surgically sterile, 2 years post-menopausal, or attest that they are using an acceptable method of contraception (including hormonal birth control, intrauterine device [IUD], double barrier methods, or vasectomized partner).
  • females of childbearing potential must have urine pregnancy test (human chorionic gonadotropin [HCG]) that is negative at Baseline.
  • must be able to read the diaries in Russian.

Exclusion Criteria: - currently under a doctor's care and treatment for constipation.

  • have current constipation episode for more than one week prior to randomization.
  • history of chronic constipation due to any underlying cause (inflammatory bowel disease, etc.).
  • history of more than 3 months of constipation in the past year.
  • have severe abdominal pain as the predominant constipation symptom.
  • had with bowel movement in 48 hours prior to randomization.
  • have celiac disease or known gluten sensitivity.
  • history of colorectal cancer, anal abscess, anal fistula, anal fissure, anal stenosis, gastric retention or obstruction, bowel resection, rectocele, or colostomy.
  • have known renal or hepatic insufficiency.
  • have gastrointestinal bleeding or acute infection.
  • history of alcohol or drug abuse.
  • history of psychiatric disorders.
  • history of significant ongoing medical problems, including kidney disease, or are scheduled for surgical procedures.
  • currently taking or have taken within 7 days of randomization a concomitant medication that causes constipation, including opiates, antidepressants, selective serotonin reuptake inhibitors (SSRIs), antimotility agents, and anticholinergics, etc.
  • plan to use laxatives during the treatment period other than the study medication.
  • have participated in an investigational clinical, surgical, drug or device study within the past 30 days. (Concurrent skin patch testing of cosmetic or suncare products is allowed.)
  • pregnant or lactating.
  • allergic to polyethylene glycol or maltodextrin.
  • employed or have immediate family members employed by a company that manufactures laxative products.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PEG 3350
Participants will receive a 17 g oral dose of 1 sachet of PEG 3350 mixed in 120 to 240 mL of water, once a day, for 7 days.
Drug: Polyethylene Glycol 3350 Powder for Solution (PEG 3350)
Other Names:
  • VivaLAX
Active Comparator: PEG 4000
Participants will receive a 10 to 20 g oral dose of 1 to 2 sachets of PEG 4000 mixed in 120 to 140 mL of water, once a day, for 7 days.
Drug: Polyethylene Glycol 4000 Powder for Solution (PEG 4000)
Other Names:
  • Forlax

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of bowel movements per week
Time Frame: Up to 7 days after start of treatment
Up to 7 days after start of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Time to first bowel movement
Time Frame: Up to 7 days after start of treatment
Up to 7 days after start of treatment
Number of participants who experience changes in straining and hard or lumpy stools
Time Frame: Up to 7 days after start of treatment
Up to 7 days after start of treatment
Number of participants who experience changes in stool consistency
Time Frame: Up to 7 days after start of treatment
Up to 7 days after start of treatment
Number of participants who experience changes in the sensation of stool evacuation
Time Frame: Up to 7 days after start of treatment
Up to 7 days after start of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 12, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 17, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18128
  • CL2012-15 (Other Identifier: Consumer Health Protocol Number)
  • 8114-005 (Other Identifier: Merck)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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