CLINICAL TRIALS PROFILE FOR MIRALAX

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.

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.

Clinical Trial Conditions for Miralax

Condition Name

Condition Name for Miralax
Intervention	Trials
Constipation	12
Colonoscopy	4
Crohn's Disease	2

Condition MeSH

Condition MeSH for Miralax
Intervention	Trials
Constipation	14
Fibrosis	3
Crohn Disease	3

Clinical Trial Locations for Miralax

Trials by Country

Trials by Country for Miralax
Location	Trials
United States	65

Trials by US State

Trials by US State for Miralax
Location	Trials
Pennsylvania	7
Illinois	6
New York	4
California	4
Ohio	4

Clinical Trial Progress for Miralax

Clinical Trial Phase

Clinical Trial Phase for Miralax
Clinical Trial Phase	Trials
Phase 4	21
Phase 3	1
Phase 2	4

Clinical Trial Status

Clinical Trial Status for Miralax
Clinical Trial Phase	Trials
Completed	18
Recruiting	9
Terminated	4

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

Sponsor Type

Sponsor Type for Miralax
Sponsor	Trials
Other	42
Industry	7
U.S. Fed	3

MiraLAX: Clinical Trials, Market Analysis, and Projections

Introduction

MiraLAX, a laxative containing the active ingredient polyethylene glycol 3350 (PEG 3350), has been a significant player in the constipation treatment market. Here, we will delve into the clinical trials, market analysis, and projections for this widely used medication.

Clinical Trials and Safety Concerns

Initial Approval and Switch to OTC

MiraLAX was initially approved as a prescription medication but made the transition to an over-the-counter (OTC) product in 2006, marking the first Rx-to-OTC switch in the laxative category in over 30 years[2].

Clinical Studies

Several clinical studies have evaluated the safety and efficacy of MiraLAX. A large, randomized, double-blind, placebo-controlled study involving 304 patients showed that MiraLAX was significantly more effective in treating constipation, with no clinically significant changes in electrolytes or hematology measures. However, gastrointestinal events such as diarrhea, flatulence, and nausea were more frequent in patients taking MiraLAX compared to the placebo group[4].

Long-Term Effects and Neuropsychiatric Symptoms

Despite its efficacy, MiraLAX has faced parental concerns regarding its long-term effects, particularly the potential link to neuropsychiatric symptoms in children. A citizen petition in 2012 urged the FDA to investigate these concerns, but the FDA partially accepted and partially denied the request, citing insufficient evidence for a boxed warning[1].

To address these concerns, researchers at the Children’s Hospital of Philadelphia have been conducting an FDA-grant-funded study to analyze the long-term effects of PEG 3350 in children. This study includes children with various health conditions, such as gastrointestinal issues and preexisting neurological concerns, as well as a control group[1].

Market Analysis

Market Size and Growth

The global laxatives market, which includes MiraLAX, is projected to grow at a Compound Annual Growth Rate (CAGR) of around 6.9% to reach approximately $8.71 billion by 2025. This growth is driven by increasing demand, particularly among the geriatric population and those under palliative care[5].

Market Segmentation

The laxatives market is segmented by route of administration, type, form, and distribution channel. MiraLAX falls under the category of osmotic laxatives, which work by drawing water into the bowel to soften stool. The market is also segmented into oral and rectal routes of administration, with oral being the dominant form for MiraLAX[5].

Distribution and Sales

MiraLAX is widely available in drug stores, grocery stores, and mass merchandisers. The switch from prescription to OTC status in 2006 significantly expanded its market reach. According to FDA data, MiraLAX and its generic equivalents accounted for the largest proportion of dispensed prescriptions for polyethylene glycol 3350 products, especially among the pediatric population[3].

Projections and Future Trends

Market Trends

The laxatives market is expected to see advancements in product development, with a focus on combinatory products involving two or more laxatives. There is also a growing need for more effective and advanced laxatives, particularly for the geriatric population[5].

Competitive Landscape

MiraLAX competes in a market dominated by several key players, including AstraZeneca plc, Boehringer Ingelheim GmbH, Bayer AG, GlaxoSmithKline, and others. The competitive landscape is expected to remain dynamic, with new entrants and existing players continually innovating to capture market share[5].

Regulatory Environment

The regulatory environment remains crucial for MiraLAX and similar products. Ongoing studies and FDA reviews will continue to shape the market and influence consumer confidence. The FDA's decision to fund studies on the long-term effects of PEG 3350 is a significant step in addressing parental concerns and ensuring the safety of the product[1].

Key Takeaways

• Clinical Efficacy: MiraLAX has been shown to be effective in treating constipation with a unique mode of action that works with the body's natural rhythm.
• Safety Concerns: Despite its efficacy, MiraLAX faces concerns over potential neuropsychiatric symptoms in children, prompting ongoing studies.
• Market Growth: The global laxatives market, including MiraLAX, is projected to grow significantly, driven by increasing demand and product innovations.
• Market Segmentation: MiraLAX is part of the osmotic laxatives segment and is widely available through various distribution channels.
• Regulatory Environment: Ongoing FDA-funded studies and regulatory reviews will continue to impact the market and consumer confidence.

FAQs

What is the active ingredient in MiraLAX?

The active ingredient in MiraLAX is polyethylene glycol 3350 (PEG 3350)[2].

When did MiraLAX switch from prescription to OTC status?

MiraLAX switched from prescription to OTC status in 2006[2].

What are the concerns regarding MiraLAX in children?

There are concerns that MiraLAX may be linked to neuropsychiatric symptoms in children, prompting ongoing studies to investigate these effects[1].

How is the global laxatives market expected to grow?

The global laxatives market is projected to grow at a CAGR of around 6.9% to reach approximately $8.71 billion by 2025[5].

What types of laxatives are available in the market?

The market includes osmotic laxatives, stimulant laxatives, stool softener laxatives, and bulk forming laxatives[5].

Who are the key players in the laxatives market?

Key players include AstraZeneca plc, Boehringer Ingelheim GmbH, Bayer AG, GlaxoSmithKline, and others[5].

Sources

1. Healio: Parental concerns over MiraLAX laxative continue to spur closer review.
2. Biospace: Schering-Plough Corporation Enters Licensing Agreement To Market Prescription MiraLAX® Over-The-Counter.
3. FDA: 203595Orig1s000 - accessdata.fda.gov.
4. MiraLAX: Studies and guidelines about OTC laxatives.
5. Businesswire: Global $8.71 Billion Laxatives Market Analysis & Trends to 2025.