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

NCT02045901 | Terminated Phase 4

• 1 other identifier: PED-301
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 8

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).

Conditions

Morning Sickness

Keywords

Nausea; Vomiting; Pregnancy; Adolescent; Diclegis; Morning; Sickness

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1-Day 15

Secondary Outcomes (1)

• Severity and occurences of maternal adverse events

  Day 1-Day 15

Study Arms (2)

Diclegis

ACTIVE COMPARATOR

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.

Drug: Diclegis

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo (Sugar Pill)

Interventions

Diclegis DRUG

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.

Also known as: Active

Diclegis

Placebo (Sugar Pill) DRUG

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.

Also known as: Vehicle

Placebo

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duchesnay Inc.: lead
• Premier Research: collaborator

Study Sites (8)

Watching Over Mothers and Babies

Tucson, Arizona, 85712, United States

Location

Clinica Del Socorro Medical Group, Inc.

Los Angeles, California, 90011, United States

Location

Futura Research

Norwalk, California, 90650, United States

Location

Medical Professional CR Center

Miami, Florida, 33165, United States

Location

Empire Clinical Research, LLC

Miami Lakes, Florida, 33016, United States

Location

Western Michigan University Homer Stryker M.D. School of Medicine

Kalamazoo, Michigan, 49008, United States

Location

Jersey Shore University Medical Center

Neptune City, New Jersey, 07753, United States

Location

Complete Healthcare for Women

Columbus, Ohio, 43213, United States

Location

MeSH Terms

Conditions

Morning Sickness; Nausea; Vomiting

Interventions

dicyclomine, doxylamine, pyridoxine drug combination; Exercise; Sugars

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Carbohydrates

Study Officials

• Gideon Koren, MD

  Hospital for Sick Children, 555 University Avenue, Toronto ON Canada, M5G-1X8

  PRINCIPAL INVESTIGATOR

• Gary Hankins, MD

  University of Texas Medical Branch, Obstetrics/Gynecology, Route 0587, Galveston Texas USA, 77550-0587

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2014
• First Posted: January 27, 2014
• Study Start: February 1, 2014
• Primary Completion: March 31, 2017
• Study Completion: October 1, 2017
• Last Updated: November 23, 2021

Record last verified: 2021-11

Locations

US (8)