A Pilot Study of a New MiraLax® Dose Formulation For Use... | NCT00319670

Studies
A Pilot Study of a New MiraLax® Dose Formulation For Use in Constipated Children

NCT00319670

Sponsor

Braintree Laboratories

Status

Completed

Last Update Posted

Feb 7, 2013Estimated

Enrollment

Phase

Phase 4

Conditions

Constipation

Interventions

MiraLax

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Mar 2006

Primary Completion Date

May 2006Actual

Completion Date

Not provided

First Submitted Date

Apr 27, 2006

First Submission Date that Met QC Criteria

Apr 27, 2006

First Posted Date

Apr 27, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 6, 2013

Last Update Posted Date

Feb 7, 2013Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
MiraLax	Drug

Measure	Description	Time Frame
Patient acceptance will be measured by analysis of subjective questionnaire data.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female constipated outpatients between the ages of 4 and 16
Currently taking a dose of less than or equal to 17g of PEG 3350 powder that has been consistent for at least 4 weeks
Current treatment is considered successful - defined as greater than 2 bowel movements per week with no accidents
Are otherwise in good health, as judged by a physical examination
If female and of childbearing potential, patient must be using oral contraceptives, depot contraceptives, intrauterine device, or testifies that she is monogamous with a vasectomized partner, or practices abstinence and will continue to do so during the duration of study
In the investigator's judgment, patient or guardian is mentally competent to sign an instrument of informed consent

Exclusion Criteria:

Patients with heme positive stool at baseline exam
Patients who are impacted at baseline exam
Patients that are not receiving PEG 3350
Patients on PEG 3350 that continue to have problems
Patients with known or suspected perforation or obstruction
Patients with a history of gastric retention, inflammatory bowel disease, bowel resection, or colostomy
Patients with a known history of organic cause for their constipation.
Patients currently using medications known to cause constipation. These include Opiates, antidepressants, SSRI's, antimotility agents and anticholinergics.
Patients who are breastfeeding, pregnant, or intend to become pregnant during the study
Female patients of childbearing potential who refuse a pregnancy test
Patients who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedure
Patients with known allergy to PEG or PEG containing medications
Patients who, within the past 30 days have participated in an investigational clinical study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

16 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Boston	Massachusetts	02115	United States

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Measure	Description	Time Frame
Efficacy will be measured by analysis of patient self-reported BM data.
Adverse events will be monitored and analyzed for safety purposes.