ConstipationPhase 3NCT02292459
Efficacy and Safety of Polyethylene Glycol 3350 (PEG 3350) for Relief of Constipation (MK-8114-005)
A Phase 3 study testing Polyethylene Glycol 3350 Powder for Solution (PEG 3350) and Polyethylene Glycol 4000 Powder for Solution (PEG 4000) in people with Constipation, run by Bayer.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constipation
- What is being tested?
- Polyethylene Glycol 3350 Powder for Solution (PEG 3350) and Polyethylene Glycol 4000 Powder for Solution (PEG 4000)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Dec 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
None listed.
About this study
Official title: 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.
- Conditions
- Constipation
- Being tested
- Polyethylene Glycol 3350 Powder for Solution (PEG 3350), Polyethylene Glycol 4000 Powder for Solution (PEG 4000)
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyethylene Glycol 3350 Powder for Solution (PEG 3350)Drug
Also called VivaLAX
Polyethylene Glycol 4000 Powder for Solution (PEG 4000)Drug
Also called Forlax
| Study group | Role | What they receive |
|---|---|---|
| PEG 3350 | Experimental | 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. Receives: Drug: Polyethylene Glycol 3350 Powder for Solution (PEG 3350) |
| PEG 4000 | Active comparator | 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. Receives: Drug: Polyethylene Glycol 4000 Powder for Solution (PEG 4000) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of bowel movements per week
Measured: Up to 7 days after start of treatment
Secondary outcomes (4)
Time to first bowel movement
Measured: Up to 7 days after start of treatment
Number of participants who experience changes in straining and hard or lumpy stools
Measured: Up to 7 days after start of treatment
Number of participants who experience changes in stool consistency
Measured: Up to 7 days after start of treatment
Number of participants who experience changes in the sensation of stool evacuation
Measured: Up to 7 days after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2014 (estimated)
- Study startDec 2015
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02292459
- Sponsor's protocol ID
- 18128
- Other IDs
- CL2012-15, 8114-005
- Status last verified
- Jul 2015
- First submitted
- 12 Nov 2014
- Last updated
- 16 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02292459
- Acronym / sponsor ID
- 18128
- Conditions
- Constipation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 17 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEG 3350 | Experimental | Drug: Polyethylene Glycol 3350 Powder for Solution (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. |
| PEG 4000 | Active comparator | Drug: Polyethylene Glycol 4000 Powder for Solution (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polyethylene Glycol 3350 Powder for Solution (PEG 3350)Also: VivaLAX | Drug | PEG 3350 |
| Polyethylene Glycol 4000 Powder for Solution (PEG 4000)Also: Forlax | Drug | PEG 4000 |
Primary outcome
Number of bowel movements per week
Time frame: Up to 7 days after start of treatment
4 secondary outcomes
Time to first bowel movement
Time frame: 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
Number of participants who experience changes in stool consistency
Time frame: 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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Polyethylene Glycol 3350 Powder for Solution (PEG 3350) and Polyethylene Glycol 4000 Powder for Solution (PEG 4000) in people with Constipation, run by Bayer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of bowel movements per week (time frame: Up to 7 days after start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2015.