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Rectal Versus Oral Diazepam Administration in the Treatment of Levator Ani Syndrome

NCT04216797 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2023-04-19

No results posted yet for this study

Summary

This research involves collecting data about levator ani syndrome (LAS) associated rectal pain and a comparison of diazepam treatment administration routes. The goal of this research is to see if an alternative route of diazepam administration provides sufficient control of LAS discomfort and low sleep quality while minimizing systemic effects of diazepam (drowsiness).

Conditions

  • Levator Ani Syndrome

Interventions

DRUG

Diazepam Tablets

Participants will be randomly assigned to either an oral or rectal administration of once daily 10 mg diazepam tablets for four weeks.

Sponsors & Collaborators

  • Swedish Medical Center

    lead OTHER

Principal Investigators

  • Cecilia A Lynn · Swedish Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-09
Primary Completion
2023-02-21
Completion
2023-02-21
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04216797 on ClinicalTrials.gov