ConstipationPhase 4NCT00770432
Study Comparing PEG 3350 Laxative to Placebo in the Treatment of Occasional Constipation (Study CL2007-12)(P08216)
A Phase 4 study testing Polyethylene glycol 3350 in people with Constipation, run by Bayer.
Trial summary
Randomized, placebo-controlled, double blind study. 203 subjects entered the study to compare the effect on occasional constipation of polyethylene glycol 3350 to placebo. Subjects took one of study treatments up to 7 days. Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Constipation
- What is being tested?
- Polyethylene glycol 3350
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 203 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to Jan 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Subjects (or parents/guardians of minors) must demonstrate their willingness to participate (or to have their children/wards participate) in the study and comply with its procedures by signing a written informed consent. Minor subjects must provide written assent.
- Subjects must be 17 years of age or older.
- Subjects must present with a current diagnosis of untreated constipation for 7 days or less based on having signs/symptoms of straining and hard or lumpy stools OR the inability to have a BM within 48 hours prior to randomization into the trial.
- Subjects must be OTC laxative users for the treatment of occasional constipation (defined as using a nonprescription laxative to treat at least 3 episodes of constipation within the last 12 months prior to randomization).
- Subjects must be willing to use study drug for up to 7 days as directed, and must agree to record bowel movement (frequency, consistency, etc.) accurately and consistently in a daily diary, and make two clinic visits.
- Subjects must be otherwise in good health, as determined by physical exam and medical history.
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- Subjects must agree not to use any other products to treat their constipation during the course of the study.
- Subjects must agree not to use any medication known to cause constipation during the course of the study.
- Subjects must agree to maintain a similar diet from the week prior to randomization through end of study.
- Female subjects must be either surgically sterile, 2 years post-menopausal, or they attest that they are using an acceptable method of contraception (including hormonal birth control, IUD, double barrier methods, or vasectomized partner). In females of childbearing potential, the urine pregnancy test (HCG) must be negative at Baseline.
- Subjects must be able to read the diaries in English.
Who cannot join
- Subjects currently under a doctor's care and treatment for constipation.
- Subjects having current constipation episode for more than one week prior to randomization.
- Subjects that have a history of chronic constipation due to any underlying cause (inflammatory bowel disease, etc.).
- Subjects have a history of more than 3 months of constipation in the past year.
- Subjects have severe abdominal pain as the predominant constipation symptom.
- Subjects who have previously used a polyethylene glycol laxative.
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- Subjects who have celiac disease or known gluten sensitivity.
- Subjects who have a history of colorectal cancer, anal abscess, anal fistula, anal fissure, anal stenosis, gastric retention or obstruction, bowel resection, rectocele, or colostomy.
- Subjects with known renal or hepatic insufficiency.
- Subjects with gastrointestinal bleeding or acute infection.
- Subjects with a history of alcohol or drug abuse.
- Subjects with a history of psychiatric disorders.
- Subjects with a history of significant ongoing medical problems, including kidney disease, or who are scheduled for surgical procedures.
- Subjects currently taking or taken within 7 days of randomization a concomitant medication that causes constipation including for example opiates, antidepressants, SSRI's, antimotility agents, and anticholinergics, etc.
- Subjects who plan to use laxatives during the treatment period other than the study medication.
- Subjects who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures.
- Subjects who have participated in an investigational clinical surgical, drug or device study within the past 30 days.
- Subjects who are pregnant or lactating.
- Subjects who are allergic to polyethylene glycol or maltodextrin.
- Subjects who are employed or have immediate family members employed by a company that manufactures laxative products.
About this study
Official title: A Randomized, Placebo-Controlled, Double-Blind, Trial of Polyethylene Glycol 3350 Laxative for the Treatment of Occasional Constipation.
Randomized, placebo-controlled, double blind study. 203 subjects entered the study to compare the effect on occasional constipation of polyethylene glycol 3350 to placebo. Subjects took one of study treatments up to 7 days.
- Conditions
- Constipation
- Being tested
- Polyethylene glycol 3350, Placebo, maltodextrin 500 powder for solution
- Keywords
- Human Experimentation
- 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 3350Drug
Also called MiraLAX®
Polyethylene glycol 3350 powder for solution. Single dose (17 grams in 4 to 8 ounces of beverage) for 7 days.
Placebo, maltodextrin 500 powder for solutionOther
Also called MALTRIN® 500 powder for solution
Maltodextrin 500 powder for solution, One single dose (one capful) in any 4 - 8 ounces beverage for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Polyethylene glycol 3350 powder for solution | Active comparator | MiraLAX® (polyethylene glycol 3350 powder for solution) Receives: Drug: Polyethylene glycol 3350 |
| Placebo | Placebo comparator | MALTRIN 500® M500 (maltodextrin 500) Receives: Other: Placebo, maltodextrin 500 powder for solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Complete Resolution at the Final Visit
A resolution was recorded if the participant has no occurrence of two or more consecutive unsuccessful bowel movements for the rest of the study following the first successful bowel movement.
Measured: 24 hours to 3 days after last dose of seven day treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2008 (estimated)
- Study startNov 2007
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00770432
- Sponsor's protocol ID
- 18130
- Other IDs
- CL2007-12, P08216
- Status last verified
- Sep 2018
- First submitted
- 9 Oct 2008
- Last updated
- 2 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
McGraw T. Polyethylene glycol 3350 in occasional constipation: A one-week, randomized, placebo-controlled, double-blind trial. World J Gastrointest Pharmacol Ther. 2016 May 6;7(2):274-82. doi: 10.4292/wjgpt.v7.i2.274.
PubMed 27158544
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Double-Blind, Trial of Polyethylene Glycol 3350 Laxative for the Treatment of Occasional Constipation.
- ClinicalTrials.gov ID
- NCT00770432
- Acronym / sponsor ID
- 18130
- Conditions
- Constipation
- Keywords
- Human Experimentation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 10 Oct 2008 (estimated)
- Results
- Posted 12 Aug 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, placebo-controlled, double blind study. 203 subjects entered the study to compare the effect on occasional constipation of polyethylene glycol 3350 to placebo. Subjects took one of study treatments up to 7 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polyethylene glycol 3350 powder for solution | Active comparator | Drug: Polyethylene glycol 3350MiraLAX® (polyethylene glycol 3350 powder for solution) |
| Placebo | Placebo comparator | Other: Placebo, maltodextrin 500 powder for solutionMALTRIN 500® M500 (maltodextrin 500) |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects (or parents/guardians of minors) must demonstrate their willingness to participate (or to have their children/wards participate) in the study and comply with its procedures by signing a written informed consent. Minor subjects must provide written assent.
- Subjects must be 17 years of age or older.
- Subjects must present with a current diagnosis of untreated constipation for 7 days or less based on having signs/symptoms of straining and hard or lumpy stools OR the inability to have a BM within 48 hours prior to randomization into the trial.
- Subjects must be OTC laxative users for the treatment of occasional constipation (defined as using a nonprescription laxative to treat at least 3 episodes of constipation within the last 12 months prior to randomization).
- Subjects must be willing to use study drug for up to 7 days as directed, and must agree to record bowel movement (frequency, consistency, etc.) accurately and consistently in a daily diary, and make two clinic visits.
Key exclusion criteria (20 listed)
- Subjects currently under a doctor's care and treatment for constipation.
- Subjects having current constipation episode for more than one week prior to randomization.
- Subjects that have a history of chronic constipation due to any underlying cause (inflammatory bowel disease, etc.).
- Subjects have a history of more than 3 months of constipation in the past year.
- Subjects have severe abdominal pain as the predominant constipation symptom.
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 3350Also: MiraLAX®Polyethylene glycol 3350 powder for solution. Single dose (17 grams in 4 to 8 ounces of beverage) for 7 days. | Drug | Polyethylene glycol 3350 powder for solution |
| Placebo, maltodextrin 500 powder for solutionAlso: MALTRIN® 500 powder for solutionMaltodextrin 500 powder for solution, One single dose (one capful) in any 4 - 8 ounces beverage for 7 days. | Other | Placebo |
Primary outcome
Number of Participants With a Complete Resolution at the Final Visit
Time frame: 24 hours to 3 days after last dose of seven day treatment period.
A resolution was recorded if the participant has no occurrence of two or more consecutive unsuccessful bowel movements for the rest of the study following the first successful bowel movement.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27158544McGraw T. Polyethylene glycol 3350 in occasional constipation: A one-week, randomized, placebo-controlled, double-blind trial. World J Gastrointest Pharmacol Ther. 2016 May 6;7(2):274-82. doi: 10.4292/wjgpt.v7.i2.274.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Polyethylene glycol 3350 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 11 inclusion and 20 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: finished, as of the sponsor's last update on 2 Oct 2018. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participants With a Complete Resolution at the Final Visit (time frame: 24 hours to 3 days after last dose of seven day treatment period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00770432, which also lists 1 linked publication.
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 2 Oct 2018.