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A Multicenter Trial of the Efficacy and Safety of Diclegis® for Nausea and Vomiting of Pregnancy in Pregnant Adolescents (PED-301)

Primary Purpose

Morning Sickness

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Diclegis
Placebo (Sugar Pill)
Sponsored by
Duchesnay Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morning Sickness focused on measuring Nausea, Vomiting, Pregnancy, Adolescent, Diclegis, Morning, Sickness

Eligibility Criteria

12 Years - 17 Years (Child)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. The participant is a pregnant female between the following ages: at least 12 years on the day of recruitment (ie, Day 1) and not yet 18 years on the last day of the study (ie, Day 15).
  2. The participant must provide written informed consent and/or assent to participate in the study, and agrees that she will follow dosing instructions and complete all required study visits.
  3. The participant's entry ultrasound indicates a viable pregnancy and confirms gestational age of the fetus is 7-15 weeks + 0 days at the anticipated time of the first dose of study drug provided that her NVP symptoms began </= 10 weeks gestation. If an ultrasound was performed within 4 weeks of the study entry visit, and results can be obtained, an additional ultrasound is not necessary.
  4. The participant is suffering from NVP and has a PUQE score ≥6.
  5. The participant has not responded to conservative management consisting of dietary/lifestyle advice according to the 2004 ACOG Practice Bulletin.
  6. The participant agrees, if on a multivitamin, to continue on her current dose of multivitamin for the duration of the trial.
  7. The participant does not plan termination of the pregnancy.
  8. On the basis of medical history, physical examination and screening laboratory tests, the participant is judged to be in good health.
  9. The participant must be able to swallow the study drug whole (ie, without splitting, crushing, or chewing the tablets).

Exclusion Criteria:

  1. The investigator confirms the participant's nausea and vomiting is of etiology other than NVP.
  2. The participant has gestational trophoblastic disease or multifetal gestation.
  3. The participant has a condition for which antihistamines, in the opinion of the investigator, are contraindicated (eg, epilepsy, alcoholism, glaucoma, chronic lung disease, urinary retention, and heart block).
  4. The participant has a known hypersensitivity to doxylamine succinate other ethanolamine derivative antihistamines, pyridoxine hydrochloride, or any inactive ingredient in the Diclegis or placebo formulation.
  5. The participant is taking a monoamine oxidase inhibitor.
  6. The participant has used antihistamines, anticholinergics, dopamine antagonists, serotonin antagonists, ginger, or anti-emetic therapy (including acupressure, acupuncture, homeopathic remedies, medical hypnosis, and relief bands) to treat NVP in the previous 48 hours or plans to do so during the study.
  7. The participant is using drugs that have anticholinergic activity (eg, tricyclic antidepressants).
  8. The participant is taking multivitamins containing more than 10 mg of vitamin B6 or plans to do so during the study.
  9. The participant is taking supplementary vitamin B6 in addition to any multivitamin preparation or plans to do so during the study (e.g, total vitamin B6 greater than 10 mg).
  10. The participant is currently drinking any amount of alcohol.
  11. The participant has any condition that might interfere with the conduct of the study, in the opinion of the investigator. For example, Diclegis® should be used with caution in females with asthma, increased intraocular pressure, narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction and urinary bladder-neck obstruction.
  12. The participant is likely to be unable to comply with study procedures because of inadequate cognitive or language skills.
  13. The participant has received an investigational drug within 30 days before enrollment in this study or is scheduled to receive an investigational drug during the course of this study.
  14. The participant is currently breastfeeding.

Sites / Locations

  • Watching Over Mothers and Babies
  • Clinica Del Socorro Medical Group, Inc.
  • Futura Research
  • Empire Clinical Research, LLC
  • Medical Professional CR Center
  • Western Michigan University Homer Stryker M.D. School of Medicine
  • Jersey Shore University Medical Center
  • Complete Healthcare for Women

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Diclegis

Placebo

Arm Description

Participants will be randomized to receive Diclegis or placebo. On Day 1, all participants will take 2 tablets of study drug at bedtime. On Days 2 to 14, participants will take 2 tablets of study drug at bedtime. The minimum dosage will be 2 tablets daily at bedtime, increasing, when indicated, to the maximal dosage of 4 tablets per day on Days 3 to 14.

Participants will be randomized to receive Diclegis or placebo. On Day 1, all participants will take 2 tablets of study drug at bedtime. On Days 2 to 14, participants will take 2 tablets of study drug at bedtime. The minimum dosage will be 2 tablets daily at bedtime, increasing, when indicated, to the maximal dosage of 4 tablets per day on Days 3 to 14.

Outcomes

Primary Outcome Measures

Nausea and Vomiting of Pregnancy Severity from Baseline to Day 15
The primary objective of this study is to compare the efficacy of Diclegis for the treatment of nausea and vomiting of pregnancy (NVP) in pregnant adolescents aged 12 to 17 years with placebo. NVP severity will be compared using the change in PUQE and Global Assessment of Well-being scores from baseline (Day 1) to Day 15 between adolescents randomized to Diclegis and placebo for 14 days.

Secondary Outcome Measures

Severity and occurences of maternal adverse events
The secondary objective of this study is to compare the safety of Diclegis in pregnant adolescents aged 12 to 17 years with placebo by assessing differences in the severity and occurrence of maternal adverse events (AEs).

Full Information

First Posted
January 22, 2014
Last Updated
November 22, 2021
Sponsor
Duchesnay Inc.
Collaborators
Premier Research Group plc
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1. Study Identification

Unique Protocol Identification Number
NCT02045901
Brief Title
A Multicenter Trial of the Efficacy and Safety of Diclegis® for Nausea and Vomiting of Pregnancy in Pregnant Adolescents
Acronym
PED-301
Official Title
A Multicenter Trial of the Efficacy and Safety of Diclegis® for Nausea and Vomiting of Pregnancy in Pregnant Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Terminated
Study Start Date
February 2014 (Actual)
Primary Completion Date
March 31, 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duchesnay Inc.
Collaborators
Premier Research Group plc

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this study is to compare the efficacy of Diclegis for the treatment of nausea and vomiting of pregnancy (NVP) in pregnant adolescents aged 12 to 17 years with placebo. The secondary objective of this study is to compare the safety of Diclegis in pregnant adolescents aged 12 to 17 years with placebo by assessing differences in the severity and occurrence of maternal adverse events (AEs).
Detailed Description
This is a multicenter study in the treatment of NVP that will actively recruit pregnant adolescents from approximately 14-16 study sites in the United States. After obtaining informed consent on Day 1, a medical examination will be conducted to ensure eligibility. Participants will be randomized to receive Diclegis or placebo. On Day 1, all participants will take 2 tablets of study drug at bedtime. On Days 2 to 14, participants will take 2 tablets of study drug at bedtime. The minimum dosage will be 2 tablets daily at bedtime, increasing, when indicated, to the maximal dosage of 4 tablets per day on Days 3 to 14. Participants will be required to complete a diary daily to assess the severity of their NVP by using the validated Pregnancy Unique Quantification of Emesis (PUQE) and to record any AEs experienced; the Global Assessment of Well being scale will be completed only on Days 1, 8 and 15. Participants will receive telephone calls daily to assess whether the current dosing regimen is sufficient at relieving NVP symptoms, to review study procedures, and to address her questions/concerns. Participants will return to the clinic for evaluation on Day 4 (±1 day) and Day 15 (±1 day) for an end of study visit. Eligible participants are those between 12 and 17 years of age, pregnant with a gestational age of 7 to 15 weeks + 0 days, suffering from NVP, with a PUQE score ≥6, and who have not responded to conservative management consisting of dietary/lifestyle advice according to the 2004 American College of Obstetrics and Gynecology (ACOG) Practice Bulletin.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morning Sickness
Keywords
Nausea, Vomiting, Pregnancy, Adolescent, Diclegis, Morning, Sickness

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
131 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diclegis
Arm Type
Active Comparator
Arm Description
Participants will be randomized to receive Diclegis or placebo. On Day 1, all participants will take 2 tablets of study drug at bedtime. On Days 2 to 14, participants will take 2 tablets of study drug at bedtime. The minimum dosage will be 2 tablets daily at bedtime, increasing, when indicated, to the maximal dosage of 4 tablets per day on Days 3 to 14.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will be randomized to receive Diclegis or placebo. On Day 1, all participants will take 2 tablets of study drug at bedtime. On Days 2 to 14, participants will take 2 tablets of study drug at bedtime. The minimum dosage will be 2 tablets daily at bedtime, increasing, when indicated, to the maximal dosage of 4 tablets per day on Days 3 to 14.
Intervention Type
Drug
Intervention Name(s)
Diclegis
Other Intervention Name(s)
Active
Intervention Description
On Day 1, all participants will take 2 tablets of Diclegis at bedtime. On Days 2 to 14, participants will take 2 tablets of Diclegis at bedtime. The minimum dosage will be 2 tablets daily at bedtime, increasing, when indicated, to the maximal dosage of 4 tablets per day on Days 3 to 14.
Intervention Type
Drug
Intervention Name(s)
Placebo (Sugar Pill)
Other Intervention Name(s)
Vehicle
Intervention Description
On Day 1, all participants will take 2 tablets of Placebo at bedtime. On Days 2 to 14, participants will take 2 tablets of Placebo at bedtime. The minimum dosage will be 2 tablets daily at bedtime, increasing, when indicated, to the maximal dosage of 4 tablets per day on Days 3 to 14.
Primary Outcome Measure Information:
Title
Nausea and Vomiting of Pregnancy Severity from Baseline to Day 15
Description
The primary objective of this study is to compare the efficacy of Diclegis for the treatment of nausea and vomiting of pregnancy (NVP) in pregnant adolescents aged 12 to 17 years with placebo. NVP severity will be compared using the change in PUQE and Global Assessment of Well-being scores from baseline (Day 1) to Day 15 between adolescents randomized to Diclegis and placebo for 14 days.
Time Frame
Day 1-Day 15
Secondary Outcome Measure Information:
Title
Severity and occurences of maternal adverse events
Description
The secondary objective of this study is to compare the safety of Diclegis in pregnant adolescents aged 12 to 17 years with placebo by assessing differences in the severity and occurrence of maternal adverse events (AEs).
Time Frame
Day 1-Day 15

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The participant is a pregnant female between the following ages: at least 12 years on the day of recruitment (ie, Day 1) and not yet 18 years on the last day of the study (ie, Day 15). The participant must provide written informed consent and/or assent to participate in the study, and agrees that she will follow dosing instructions and complete all required study visits. The participant's entry ultrasound indicates a viable pregnancy and confirms gestational age of the fetus is 7-15 weeks + 0 days at the anticipated time of the first dose of study drug provided that her NVP symptoms began </= 10 weeks gestation. If an ultrasound was performed within 4 weeks of the study entry visit, and results can be obtained, an additional ultrasound is not necessary. The participant is suffering from NVP and has a PUQE score ≥6. The participant has not responded to conservative management consisting of dietary/lifestyle advice according to the 2004 ACOG Practice Bulletin. The participant agrees, if on a multivitamin, to continue on her current dose of multivitamin for the duration of the trial. The participant does not plan termination of the pregnancy. On the basis of medical history, physical examination and screening laboratory tests, the participant is judged to be in good health. The participant must be able to swallow the study drug whole (ie, without splitting, crushing, or chewing the tablets). Exclusion Criteria: The investigator confirms the participant's nausea and vomiting is of etiology other than NVP. The participant has gestational trophoblastic disease or multifetal gestation. The participant has a condition for which antihistamines, in the opinion of the investigator, are contraindicated (eg, epilepsy, alcoholism, glaucoma, chronic lung disease, urinary retention, and heart block). The participant has a known hypersensitivity to doxylamine succinate other ethanolamine derivative antihistamines, pyridoxine hydrochloride, or any inactive ingredient in the Diclegis or placebo formulation. The participant is taking a monoamine oxidase inhibitor. The participant has used antihistamines, anticholinergics, dopamine antagonists, serotonin antagonists, ginger, or anti-emetic therapy (including acupressure, acupuncture, homeopathic remedies, medical hypnosis, and relief bands) to treat NVP in the previous 48 hours or plans to do so during the study. The participant is using drugs that have anticholinergic activity (eg, tricyclic antidepressants). The participant is taking multivitamins containing more than 10 mg of vitamin B6 or plans to do so during the study. The participant is taking supplementary vitamin B6 in addition to any multivitamin preparation or plans to do so during the study (e.g, total vitamin B6 greater than 10 mg). The participant is currently drinking any amount of alcohol. The participant has any condition that might interfere with the conduct of the study, in the opinion of the investigator. For example, Diclegis® should be used with caution in females with asthma, increased intraocular pressure, narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction and urinary bladder-neck obstruction. The participant is likely to be unable to comply with study procedures because of inadequate cognitive or language skills. The participant has received an investigational drug within 30 days before enrollment in this study or is scheduled to receive an investigational drug during the course of this study. The participant is currently breastfeeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gideon Koren, MD
Organizational Affiliation
Hospital for Sick Children, 555 University Avenue, Toronto ON Canada, M5G-1X8
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gary Hankins, MD
Organizational Affiliation
University of Texas Medical Branch, Obstetrics/Gynecology, Route 0587, Galveston Texas USA, 77550-0587
Official's Role
Principal Investigator
Facility Information:
Facility Name
Watching Over Mothers and Babies
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Clinica Del Socorro Medical Group, Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90011
Country
United States
Facility Name
Futura Research
City
Norwalk
State/Province
California
ZIP/Postal Code
90650
Country
United States
Facility Name
Empire Clinical Research, LLC
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Medical Professional CR Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Western Michigan University Homer Stryker M.D. School of Medicine
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49008
Country
United States
Facility Name
Jersey Shore University Medical Center
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Facility Name
Complete Healthcare for Women
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Multicenter Trial of the Efficacy and Safety of Diclegis® for Nausea and Vomiting of Pregnancy in Pregnant Adolescents

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