Abortion in First TrimesterPhase 3DexMabNCT03480009
Dextromethorphan as a Novel Non-opioid Adjunctive Agent for Pain Control in Medication Abortion
A Phase 3 study testing Dextromethorphan Hydrobromide, Avicel PH101 (Microcrystalline Cellulose NF) for Compounding and Oxycodone in people with Abortion in First Trimester, run by Study Investigator-Sponsor at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abortion in First Trimester
- What is being tested?
- Dextromethorphan Hydrobromide, Avicel PH101 (Microcrystalline Cellulose NF) for Compounding and Oxycodone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Jul 2018to 30 Jun 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women aged 18 and over
- Willing to give voluntary consent
- English-speaking
- Eligible for medication abortion per Planned Parenthood of Western Pennsylvania protocol
- Self-reported reliable cellular phone access for the duration of study participation
- Able to receive and reply to a "test" text at time of consent
- Willing to comply with the study protocol
Who cannot join
- Use of selective serotonin reuptake inhibitors or monoamine oxidase inhibitors due to risk of Serotonin Syndrome
- Allergy to any component of the medication abortion regimen or study drug
- Has any other condition that, in the opinion of the investigator, would preclude informed consent, make study participation unsafe, complicate the interpretation of the study outcome data, or otherwise interfere with achieving the study objectives
- Anticipated use of dextromethorphan during study period
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Center for Family Planning Research, Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213
Planned Parenthood of Western Pennsylvania
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Dextromethorphan as a Novel Non-opioid Adjunctive Agent for Pain Control in Medication Abortion: a Randomized Controlled Trial
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).
Read the detailed description
Medication abortion using mifepristone and misoprostol is common, accounting for nearly one-third of abortions in the United States in 2014. Although women generally tolerate medical abortion well, pain and bleeding are common and expected side effects. Up to a quarter of women rate their pain as severe during their procedure. Pain management for medical abortion is challenging given that the most acute pain occurs at home rather than under the supervision of medical professionals. Currently there is insufficient evidence to recommend an optimal regimen for pain control in medication abortion and there are concerns surrounding narcotic prescribing and the opiate abuse epidemic. This is a four-arm, prospective, double-blind, randomized controlled trial comparing dextromethorphan administration in conjunction with the current standard regimen (NSAIDs and narcotic medication by request- commonly oxycodone or codeine) to the standard regimen alone. Pain will be evaluated by analgesia usage and self-reported pain scores. Investigators will also investigate factors influencing pain and subjective components of the patient narrative. Ideally, a non-opioid adjunct to NSAIDs or narcotics could be used to control pain and significantly curtail or avoid opioid use. Investigators seek to test the efficacy and safety of dextromethorphan as a non-narcotic analgesic for medication abortion.
- Conditions
- Abortion in First Trimester
- Being tested
- Dextromethorphan Hydrobromide, Avicel PH101 (Microcrystalline Cellulose NF) for Compounding, Oxycodone
- Keywords
- medication abortion, dextromethorphan, pain control
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dextromethorphan HydrobromideDrug
Also called Robitussin, Delsym
Dextromethorphan capsule
Avicel PH101 (Microcrystalline Cellulose NF) for CompoundingDrug
Also called Avicel
Placebo capsule
OxycodoneDrug
Also called Tylox, Percodan, OxyContin
Participants may opt for the narcotic receiving arms of the study, before being randomized to dextromethorphan/placebo.
| Study group | Role | What they receive |
|---|---|---|
| Dextromethorphan, opted for narcotic prescription | Experimental | Dextromethorphan hydrobromide and patient opts for narcotics (oxycodone or other standard narcotics) Receives: Drug: Dextromethorphan Hydrobromide; Drug: Oxycodone |
| Placebo, opted for narcotic prescription | Placebo comparator | Avicel PH101 (Microcrystalline Cellulose NF) and patient opts for narcotics (oxycodone or other standard narcotics) Receives: Drug: Avicel PH101 (Microcrystalline Cellulose NF) for Compounding; Drug: Oxycodone |
| Dextromethorphan, declined narcotic prescription | Experimental | Dextromethorphan hydrobromide and patient declines narcotic Receives: Drug: Dextromethorphan Hydrobromide |
| Placebo, declined narcotic prescription | Placebo comparator | Avicel PH101 (Microcrystalline Cellulose NF) for Compounding and patient declines narcotic Receives: Drug: Avicel PH101 (Microcrystalline Cellulose NF) for Compounding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Worst Pain Measurement Via Numeric Rating Scale (NRS-11)
Self-reported pain measurement via text-messaging system during first 24 hours after misoprostol administration. The scale is from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain possible".
Measured: Over 24 hours starting from misoprostol administration
Analgesic Usage During Medication Abortion
Analgesic usage by study arm for women who received dextromethorphan vs. placebo as adjunct to routine pain management during medication abortion; missing data are for participants who did not take the specified pain medication.
Measured: Over 24 hours
Secondary outcomes (2)
Mean Pain Scores Via Numeric Rating Scale (NRS-11)
Marginal mean pain scores via Numeric Rating Scale (NRS-11) over 24 hours. The scale is from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain possible".
Measured: Marginal mean pain scores over 24 hours
Number of Participants With Pain Control Satisfaction Via 4-pt Likert Scale
Overall satisfaction with pain control, "4" being - "Very good" and "1" being "Very bad"
Measured: 24 hours after misoprostol administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start28 Jul 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Abortion in First TrimesterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Study Investigator-Sponsor
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Planning
- Responsible party
- Sponsor-investigator, Study Investigator-Sponsor, University of Pittsburgh
- Investigators
- Principal Investigator, MD MPH, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03480009
- Sponsor's protocol ID
- STUDY19020221
- Acronym
- DexMab
- Status last verified
- Jul 2020
- First submitted
- 15 Feb 2018
- Last updated
- 6 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Penney G. Treatment of pain during medical abortion. Contraception. 2006 Jul;74(1):45-7. doi: 10.1016/j.contraception.2006.03.002. Epub 2006 May 6.
PubMed 16781260Weinbroum AA, Rudick V, Paret G, Ben-Abraham R. The role of dextromethorphan in pain control. Can J Anaesth. 2000 Jun;47(6):585-96. doi: 10.1007/BF03018952.
PubMed 10875724Ilkjaer S, Nielsen PA, Bach LF, Wernberg M, Dahl JB. The effect of dextromethorphan, alone or in combination with ibuprofen, on postoperative pain after minor gynaecological surgery. Acta Anaesthesiol Scand. 2000 Aug;44(7):873-7. doi: 10.1034/j.1399-6576.2000.440715.x.
PubMed 10939702Christie A, Dagfinrud H, Dale O, Schulz T, Hagen KB. Collection of patient-reported outcomes;--text messages on mobile phones provide valid scores and high response rates. BMC Med Res Methodol. 2014 Apr 16;14:52. doi: 10.1186/1471-2288-14-52.
PubMed 24735061Practice bulletin no. 143: medical management of first-trimester abortion. Obstet Gynecol. 2014 Mar;123(3):676-692. doi: 10.1097/01.AOG.0000444454.67279.7d.
PubMed 24553166Ferguson GP, Achilles SL, Meyn LA, Krajewski CM, Chappell CA, Vinekar K, Chen BA. Dextromethorphan as a novel nonopioid adjunctive agent for pain control with medication abortion: A randomized controlled trial. Contraception. 2023 Feb;118:109908. doi: 10.1016/j.contraception.2022.10.010. Epub 2022 Nov 2.
PubMed 36332661
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dextromethorphan as a Novel Non-opioid Adjunctive Agent for Pain Control in Medication Abortion: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03480009
- Acronym / sponsor ID
- DexMab / STUDY19020221
- Conditions
- Abortion in First Trimester
- Keywords
- medication abortion, dextromethorphan, pain control
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Study Investigator-SponsorUniversity, hospital or other
- Collaborators
- Society of Family Planning
- Study start
- 28 Jul 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 27 Mar 2018 (actual)
- Results
- Posted 6 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Medication abortion using mifepristone and misoprostol is common, accounting for nearly one-third of abortions in the United States in 2014. Although women generally tolerate medical abortion well, pain and bleeding are common and expected side effects. Up to a quarter of women rate their pain as severe during their procedure. Pain management for medical abortion is challenging given that the most acute pain occurs at home rather than under the supervision of medical professionals. Currently there is insufficient evidence to recommend an optimal regimen for pain control in medication abortion and there are concerns surrounding narcotic prescribing and the opiate abuse epidemic. This is a four-arm, prospective, double-blind, randomized controlled trial comparing dextromethorphan administration in conjunction with the current standard regimen (NSAIDs and narcotic medication by request- commonly oxycodone or codeine) to the standard regimen alone. Pain will be evaluated by analgesia usage and self-reported pain scores. Investigators will also investigate factors influencing pain and subjective components of the patient narrative. Ideally, a non-opioid adjunct to NSAIDs or narcotics could be used to control pain and significantly curtail or avoid opioid use. Investigators seek to test the efficacy and safety of dextromethorphan as a non-narcotic analgesic for medication abortion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Dextromethorphan, opted for narcotic prescription | Experimental | Drug: Dextromethorphan Hydrobromide, Drug: OxycodoneDextromethorphan hydrobromide and patient opts for narcotics (oxycodone or other standard narcotics) |
| Placebo, opted for narcotic prescription | Placebo comparator | Drug: Avicel PH101 (Microcrystalline Cellulose NF) for Compounding, Drug: OxycodoneAvicel PH101 (Microcrystalline Cellulose NF) and patient opts for narcotics (oxycodone or other standard narcotics) |
| Dextromethorphan, declined narcotic prescription | Experimental | Drug: Dextromethorphan HydrobromideDextromethorphan hydrobromide and patient declines narcotic |
| Placebo, declined narcotic prescription | Placebo comparator | Drug: Avicel PH101 (Microcrystalline Cellulose NF) for CompoundingAvicel PH101 (Microcrystalline Cellulose NF) for Compounding and patient declines narcotic |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Women aged 18 and over
- Willing to give voluntary consent
- English-speaking
- Eligible for medication abortion per Planned Parenthood of Western Pennsylvania protocol
- Self-reported reliable cellular phone access for the duration of study participation
Key exclusion criteria (4 listed)
- Use of selective serotonin reuptake inhibitors or monoamine oxidase inhibitors due to risk of Serotonin Syndrome
- Allergy to any component of the medication abortion regimen or study drug
- Has any other condition that, in the opinion of the investigator, would preclude informed consent, make study participation unsafe, complicate the interpretation of the study outcome data, or otherwise interfere with achieving the study objectives
- Anticipated use of dextromethorphan during study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dextromethorphan HydrobromideAlso: Robitussin, DelsymDextromethorphan capsule | Drug | Dextromethorphan, declined narcotic prescription, Dextromethorphan, opted for narcotic prescription |
| Avicel PH101 (Microcrystalline Cellulose NF) for CompoundingAlso: AvicelPlacebo capsule | Drug | Placebo, declined narcotic prescription, Placebo, opted for narcotic prescription |
| OxycodoneAlso: Tylox, Percodan, OxyContinParticipants may opt for the narcotic receiving arms of the study, before being randomized to dextromethorphan/placebo. | Drug | Dextromethorphan, opted for narcotic prescription, Placebo, opted for narcotic prescription |
Primary outcome
Worst Pain Measurement Via Numeric Rating Scale (NRS-11)
Time frame: Over 24 hours starting from misoprostol administration
Self-reported pain measurement via text-messaging system during first 24 hours after misoprostol administration. The scale is from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain possible".
Analgesic Usage During Medication Abortion
Time frame: Over 24 hours
Analgesic usage by study arm for women who received dextromethorphan vs. placebo as adjunct to routine pain management during medication abortion; missing data are for participants who did not take the specified pain medication.
2 secondary outcomes
Mean Pain Scores Via Numeric Rating Scale (NRS-11)
Time frame: Marginal mean pain scores over 24 hours
Number of Participants With Pain Control Satisfaction Via 4-pt Likert Scale
Time frame: 24 hours after misoprostol administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16781260Penney G. Treatment of pain during medical abortion. Contraception. 2006 Jul;74(1):45-7. doi: 10.1016/j.contraception.2006.03.002. Epub 2006 May 6.
- Background: PubMed 10875724Weinbroum AA, Rudick V, Paret G, Ben-Abraham R. The role of dextromethorphan in pain control. Can J Anaesth. 2000 Jun;47(6):585-96. doi: 10.1007/BF03018952.
- Background: PubMed 10939702Ilkjaer S, Nielsen PA, Bach LF, Wernberg M, Dahl JB. The effect of dextromethorphan, alone or in combination with ibuprofen, on postoperative pain after minor gynaecological surgery. Acta Anaesthesiol Scand. 2000 Aug;44(7):873-7. doi: 10.1034/j.1399-6576.2000.440715.x.
- Background: PubMed 24735061Christie A, Dagfinrud H, Dale O, Schulz T, Hagen KB. Collection of patient-reported outcomes;--text messages on mobile phones provide valid scores and high response rates. BMC Med Res Methodol. 2014 Apr 16;14:52. doi: 10.1186/1471-2288-14-52.
- Background: PubMed 24553166Practice bulletin no. 143: medical management of first-trimester abortion. Obstet Gynecol. 2014 Mar;123(3):676-692. doi: 10.1097/01.AOG.0000444454.67279.7d.
- Derived from this study: PubMed 36332661Ferguson GP, Achilles SL, Meyn LA, Krajewski CM, Chappell CA, Vinekar K, Chen BA. Dextromethorphan as a novel nonopioid adjunctive agent for pain control with medication abortion: A randomized controlled trial. Contraception. 2023 Feb;118:109908. doi: 10.1016/j.contraception.2022.10.010. Epub 2022 Nov 2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Principal Investigator, MD MPH principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dextromethorphan Hydrobromide, Avicel PH101 (Microcrystalline Cellulose NF) for Compounding and Oxycodone in people with Abortion in First Trimester, run by Study Investigator-Sponsor at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Worst Pain Measurement Via Numeric Rating Scale (NRS-11) (time frame: Over 24 hours starting from misoprostol administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03480009, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2020.