Néevo®/NéevoDHA® P.L.U.S. Program (Progress Through Learn... | NCT01358552

Studies
Néevo®/NéevoDHA® P.L.U.S. Program (Progress Through Learning, Understand & Support)

NCT01358552

Sponsor

Pamlab, Inc.

Status

Terminated

Last Update Posted

May 1, 2013Estimated

Enrollment

53Actual

Phase

Not provided

Conditions

Pregnancy

Interventions

Néevo®/ NéevoDHA®

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

Apr 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Insufficient number of participants

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Mar 2012Actual

Completion Date

Mar 2012Actual

First Submitted Date

May 18, 2011

First Submission Date that Met QC Criteria

May 20, 2011

First Posted Date

May 23, 2011Estimated

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

Apr 30, 2013

Last Update Posted Date

May 1, 2013Estimated

Name	Class
InfoMedics, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is an observational study in which patients who have been prescribed Néevo®/NéevoDHA® are invited to participate in surveys about their pregnancy and experiences with Néevo®/NéevoDHA®. The purpose of this study is to increase the understanding of the role of L-methylfolate among patients who are candidates for Néevo®/NéevoDHA®, provide patients with personalized education and support during their pregnancies, and contribute to the overall understanding of the needs and concerns of women facing intermediate- to high-risk pregnancies.

Detailed Description

Surveys used to conduct this study will be administered via telephone or online by InfoMedics, Inc., a company with a system for developing such patient-physician feedback programs. Participating physicians will ask their patients to participate in the program after Néevo®/NéevoDHA® has been prescribed and provide them with a patient brochure containing an introduction to the program and instructions on how to enroll. Patients interested in participating self-enroll, take a brief survey before starting their Néevo®/NéevoDHA® prescription, and then a follow-up survey 4 weeks after they have started taking Néevo®/NéevoDHA®. As patients complete surveys within the study, their physician will receive individualized feedback reports outlining their patient's treatment experience and progress. Patients will also receive a copy of their own reports, to help encourage them to continue taking Néevo®/NéevoDHA® as directed. Patients will also receive educational materials about diet and nutrition during pregnancy.

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

53Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Néevo®/NéevoDHA®		Subjects who have been prescribed Néevo/NéevoDHA® daily.	Other: Néevo®/ NéevoDHA®

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Néevo®/ NéevoDHA®	Other	Néevo®/NéevoDHA® is an orally administered medical food indicated for the dietary management of impaired metabolic processes in women under a doctor's care who face high to intermediate risk pregnancies and are unable to fully metabolize or absorb folic acid. Néevo®/ NéevoDHA® contains L-methylfolate, the biologically active and immediately bioavailable form of folate.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine the safety and tolerability of Néevo®/NéevoDHA® as measured by side effects and compliance	To collect data from patient surveys on the patient utilization and effectiveness of Néevo®/NéevoDHA® in a "real world" setting.	Week 4

Secondary Outcomes

Measure	Description	Time Frame
To determine overall patient satisfaction with Néevo®/NéevoDHA® using a 9-point satisfaction scale		Week 4

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

New Néevo®/NéevoDHA® Start.
Only for women who are pregnant and taking brand name Néevo®/ NéevoDHA® under a physicians care.

Exclusion Criteria:

Patients who are not pregnant.
If participant indicates that she did not get a prescription for Néevo®/ NéevoDHA®, she will not be able to complete the survey(s).
For the follow-up survey, if the participant indicates that she has not been taking Néevo®/NéevoDHA®, she will not be able to complete the survey( (s).

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

39 Years

Standard Ages

Adult

Study Population

Pregnant women who have been prescribed Néevo®/ NéevoDHA®

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Noe Lira, M.D.	Noe Lira, M.D.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Noe Lira, M.D.		Corpus Christi	Texas	78411	United States

Condition Browse Module

MeSH Terms

ID	Term
D000090463	Iron Deficiencies

Ancestor Terms

ID	Term
D019189	Iron Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided