CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 156 enrolled
Drug / intervention
Dextromethorphan Hydrobromide +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03480009
NCT03480009Phase 3Completed
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Dextromethorphan as a Novel Non-opioid Adjunctive Agent for Pain Control in Medication Abortion: a Randomized Controlled Trial

Study Investigator-Sponsor·interventional·Posted Mar 27, 2018·Updated Aug 6, 2020

In Brief

A Phase 3 clinical trial evaluating Dextromethorphan Hydrobromide, Avicel PH101 (Microcrystalline Cellulose NF) for Compounding, and 1 other intervention for Abortion in First Trimester. Completed, enrolled 156 participants across 2 sites.

Detailed Summary

This study evaluates dextromethorphan as a non-opioid adjunctive medication for pain control during medication abortion. This is double-blinded, four-arm randomized controlled trial enrolling 156 women over a period of 9-12 months: Receiving narcotics+dextromethorphan, narcotics and placebo (microcrystalline cellulose), no narcotics and dextromethorphan and no narcotics and placebo (microcrystalline cellulose).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAbortion in First Trimester
CountriesUnited States
CollaboratorsSociety of Family Planning

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedMar 27, 2018
Enrollment StartJul 28, 2018
Primary CompletionJun 30, 2019
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 8.3 years ago

Interventions

Dextromethorphan Hydrobromidedrug

Dextromethorphan capsule

Avicel PH101 (Microcrystalline Cellulose NF) for Compoundingdrug

Placebo capsule

Oxycodonedrug

Participants may opt for the narcotic receiving arms of the study, before being randomized to dextromethorphan/placebo.