Claim Your New User Special: Get your second month free ▶ Second Month Free

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Moodys
Boehringer Ingelheim
Express Scripts
Johnson and Johnson
McKinsey

Last Updated: May 27, 2022

CLINICAL TRIALS PROFILE FOR MIRALAX


✉ Email this page to a colleague

« Back to Dashboard

505(b)(2) Clinical Trials for Miralax

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT04380090 ↗ Post-Operative Constipation Following Total Knee Arthroplasty Completed The Cleveland Clinic Phase 2 2020-02-20 Postoperative constipation, defined as no fully satisfying bowel movement within the first three postoperative days, is a common occurrence with some researchers estimating that between 41 and 85% of postoperative patients experience symptoms. Causes include intraoperative medications, postoperative opioid analgesics, decreased mobility, and decreased oral intake. Constipation significantly impacts quality of life following surgery. Current standard of care for preventing postoperative constipation for patients having a single total knee arthroplasty at Cleveland Clinic is discharge on postoperative day one with either a prescription to be filled for docusate sodium (brand name Colace┬«) 100 mg to be taken two times a day by mouth for twenty eight days or the filled prescription, plus discharge instructions on ways to avoid and treat constipation. Research results show that docusate sodium is ineffective for preventing postoperative constipation in orthopedic surgery patients, and anecdotal reports confirm this finding. The proposed study uses a 2-group non-equivalent cohort design to evaluate the effect of one standard dose (17 grams) of an over-the-counter osmotic laxative (propylene glycol (PEG 3350), brand name Miralax) by mouth prior to discharge to the current standard of care. The primary outcome measure is whether patients report of a fully satisfying, normal for them, bowel movement within the first three postoperative days. Patient reported data will be collected by phone call four to seven days following surgery. Pertinent patient characteristics will be abstracted from the electronic medical record. The sample will consist of patients over twenty years old having a single total knee arthroplasty by Drs. Stearns, Molloy, or Murray who are admitted to unit 5D at Cleveland Clinic Lutheran Hospital postoperatively. Intent to treat analysis will be performed using logistic and linear regression models, adjusting for differences between groups on patient and surgical characteristics. Based on use of a two-sided Pearson chi-square test with 80% power and significance level of 0.05, 49 patients per group are required to detect a 25% decrease in constipation rate. To account for attrition we will over sample by 50% for a total of 74 per group or 148 total participants.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Miralax

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00319670 ↗ A Pilot Study of a New MiraLax┬« Dose Formulation For Use in Constipated Children Completed Braintree Laboratories Phase 4 2006-03-01 To evaluate patient acceptance of a new MiraLax dose formulation in children currently treated with polyethylene glycol 3350 powder for treatment of constipation.
NCT00467350 ↗ Comparison Trial of Enema vs. PEG 3350 for Constipation Terminated Children's Mercy Hospital Kansas City N/A 2006-12-01 The purpose of this study is to determine if milk and molasses enema or PEG 3350 works better for treatment of fecal impaction in children who are constipated.
NCT00765557 ↗ Randomized, Double-Blinded, Placebo-Controlled Trial of Laxatives for Children With Urge Syndrome Completed Department of Urology Early Phase 1 2007-12-10 HYPOTHESIS: Is MiraLAX an effective treatment of pediatric urinary urge syndrome? OBJECTIVE: Polyethylene glycol (PEG) is common first-line therapy for urinary symptoms despite minimal evidence-based support. We performed a randomized, double-blind, placebo-controlled study of PEG for initial treatment of urinary urge symptoms. SUMMARY: Only patients of investigators and sub-investigators will be recruited for this study. Children with urinary incontinence, urinary frequency, diurnal incontinence, Urinary Tract Infection (UTI) and/or reflux validated by bladder/bowel symptom questionnaire to have Urge Syndrome (US) are eligible for this study. A standardized questionnaire of bowel/bladder activity will be administered and a KUB obtained as standard of care at entry to the study. A standard 1-day voiding diary will be completed at home before beginning therapy. To exclude patients potentially still in the process of toilet training, only subjects 4 years of age and older will be studied. Other exclusion criteria will include known neurological disorders, a diagnosis of attention deficit disorder, bladder symptoms less than 6 months in duration at presentation, other bladder dysfunctions besides US, a history of anorectal malformation and pregnancy. Based upon prior experience that patients with encopresis were not likely to achieve improved stooling with only a few weeks of laxative therapy, they will also be excluded. Those accepted into the study will be randomized to receive either laxative or placebo once daily for one month. Preparation of the laxative and placebo and patient randomization will be performed by the Children's Medical Center Investigational Drug Pharmacist. Premixed study medications will be available at the Urology clinic ready to be dispensed to the patient by the study coordinator after being screened and randomized. Dosage includes children age 4-6 years (8.5 gms) and children 7-10 years (17gms). The medication will be divided into daily doses by the Investigational Pharmacist. Written and verbal instructions, both in English and Spanish, will be provided to the parents/guardian of the subjects. The Investigational Drug Pharmacist will be blinded to all patient data, and physicians and nurses evaluating patients will be blinded to randomization of these patients to laxative versus placebo arms.
NCT00765557 ↗ Randomized, Double-Blinded, Placebo-Controlled Trial of Laxatives for Children With Urge Syndrome Completed University of Texas Southwestern Medical Center Early Phase 1 2007-12-10 HYPOTHESIS: Is MiraLAX an effective treatment of pediatric urinary urge syndrome? OBJECTIVE: Polyethylene glycol (PEG) is common first-line therapy for urinary symptoms despite minimal evidence-based support. We performed a randomized, double-blind, placebo-controlled study of PEG for initial treatment of urinary urge symptoms. SUMMARY: Only patients of investigators and sub-investigators will be recruited for this study. Children with urinary incontinence, urinary frequency, diurnal incontinence, Urinary Tract Infection (UTI) and/or reflux validated by bladder/bowel symptom questionnaire to have Urge Syndrome (US) are eligible for this study. A standardized questionnaire of bowel/bladder activity will be administered and a KUB obtained as standard of care at entry to the study. A standard 1-day voiding diary will be completed at home before beginning therapy. To exclude patients potentially still in the process of toilet training, only subjects 4 years of age and older will be studied. Other exclusion criteria will include known neurological disorders, a diagnosis of attention deficit disorder, bladder symptoms less than 6 months in duration at presentation, other bladder dysfunctions besides US, a history of anorectal malformation and pregnancy. Based upon prior experience that patients with encopresis were not likely to achieve improved stooling with only a few weeks of laxative therapy, they will also be excluded. Those accepted into the study will be randomized to receive either laxative or placebo once daily for one month. Preparation of the laxative and placebo and patient randomization will be performed by the Children's Medical Center Investigational Drug Pharmacist. Premixed study medications will be available at the Urology clinic ready to be dispensed to the patient by the study coordinator after being screened and randomized. Dosage includes children age 4-6 years (8.5 gms) and children 7-10 years (17gms). The medication will be divided into daily doses by the Investigational Pharmacist. Written and verbal instructions, both in English and Spanish, will be provided to the parents/guardian of the subjects. The Investigational Drug Pharmacist will be blinded to all patient data, and physicians and nurses evaluating patients will be blinded to randomization of these patients to laxative versus placebo arms.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Miralax

Condition Name

Condition Name for Miralax
Intervention Trials
Constipation 9
Colonoscopy 4
Cirrhosis 2
Hepatic Encephalopathy 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Miralax
Intervention Trials
Constipation 11
Fibrosis 3
Crohn Disease 3
Brain Diseases 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Miralax

Trials by Country

Trials by Country for Miralax
Location Trials
United States 62
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Miralax
Location Trials
Pennsylvania 7
Illinois 6
New York 4
California 4
Massachusetts 4
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Miralax

Clinical Trial Phase

Clinical Trial Phase for Miralax
Clinical Trial Phase Trials
Phase 4 18
Phase 3 1
Phase 2 4
[disabled in preview] 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Miralax
Clinical Trial Phase Trials
Completed 18
Recruiting 8
Terminated 4
[disabled in preview] 3
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Miralax

Sponsor Name

Sponsor Name for Miralax
Sponsor Trials
Gastroenterology Services, Ltd. 3
Children's Hospital of Philadelphia 3
AstraZeneca 2
[disabled in preview] 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Miralax
Sponsor Trials
Other 39
Industry 7
U.S. Fed 3
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Dow
McKinsey
McKesson
Moodys
Baxter

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.