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

NCT04216797 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: STUDY2019000291
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Effectiveness of rectal administration versus oral administration in LAS pain management: Visual Analog Scale (VAS)

  Participants will complete weekly electronic Visual Analog Scale (VAS) for pain for 6 weeks while on Physical Therapy only, followed by 4 weeks while taking diazepam (orally or rectally). Participants will be asked to select a number on a scale of 1 to 10, where 1 equals no pain and 10 equals worst pain.

  10 weeks

Secondary Outcomes (3)

• Participant drowsiness while taking diazepam rectally versus orally

  10 weeks

• Participant sleep quality while taking diazepam rectally versus orally: Pittsburg Sleep Quality Index

  10 weeks

• Study Medication Adherence

  4 weeks

Study Arms (2)

Oral Administration

ACTIVE COMPARATOR

10 mg diazepam tablets to be taken orally once daily for 4 weeks.

Drug: Diazepam Tablets

Rectal Administration

ACTIVE COMPARATOR

10 mg diazepam tablets to be taken rectally once daily for 4 weeks.

Drug: Diazepam Tablets

Interventions

Diazepam Tablets DRUG

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

Oral Administration; Rectal Administration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a diagnosis of LAS according to the Rome IV criteria with:
• Chronic or recurrent rectal pain or aching
• Episodes lasting 30 minutes or longer
• Tenderness during traction on the puborectalis
• Patients who agree to undergo pelvic floor PT for six weeks prior to starting the medication treatment.
• Women ≥ 18 years of age. Women of childbearing potential must undergo urine pregnancy testing prior to using the treatment medication.
• Men ≥ 18 years of age.

You may not qualify if:

• Participants who have had pelvic floor surgery or with recent conditions in which rectal suppositories are contraindicated.
• Non-English speaking participants.
• Women who are pregnant or breastfeeding.
• Participants who are cognitively impaired, illiterate, or have a condition in which they are unable to consent for themselves.
• Prisoners.
• Participants allergic to benzodiazepines or have a sensitivity/intolerance to benzodiazepines.
• Participants to which benzodiazepines are contraindicated or are on medications that interact with benzodiazepines.
• Participants with current or history of Diagnostic and Statistical Manual of Mental Disorders (DSM-V) substance use disorder or Participants with a history of evidence of severe illness or any other conditions that would affect absorption or make the patient unsuitable for the study in the opinion of the investigator.
• Participants already receiving medications in the benzodiazepine class within 2 weeks of screening visit for any reasons will be excluded based on increased risk for medication tolerance.
• Participants who have undergone pelvic floor PT within 2 weeks of screening visit.

Sponsors & Collaborators

• Swedish Medical Center: lead

Study Sites (1)

Swedish Medical Center Colon Rectal Clinic

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Levator syndrome

Interventions

Diazepam

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Cecilia A Lynn

  Swedish Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will initially receive 6 weeks of pelvic floor PT. After these six weeks, qualifying participants will be randomized to one of two arms: rectal or oral diazepam administration. Participants will be dispensed 30, 10 mg diazepam tablets to take daily (oral or rectal) for 4 weeks.

Study Record Dates

• First Submitted: December 23, 2019
• First Posted: January 3, 2020
• Study Start: January 9, 2020
• Primary Completion: February 21, 2023
• Study Completion: February 21, 2023
• Last Updated: April 19, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)