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Double-Blind Randomized Drug for Myofascial Pelvic Pain (ICECAN Trial)

Phase 4
Waitlist Available
Led By Thomas Chelimsky, MD
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women aged between 18 and 80 years old
Healthy controls; Patients diagnosed with Interstitial cystitis/Painful bladder syndrome (IC/BPS) or Myofascial pelvic pain (MPP)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights

ICECAN Trial Summary

This trial will investigate whether changes in the autonomic nervous system contribute to the development of IC/BPS in women.

Eligible Conditions
  • Interstitial Cystitis/Painful Bladder Syndrome
  • Myofascial Pelvic Pain

ICECAN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

ICECAN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Correlation between the change in Autonomic Nervous System Responsiveness (ANS-R) and the change in the connectivity between prefrontal cortex (PFC) and periaqueductal gray (PAG)

ICECAN Trial Design

2Treatment groups
Experimental Treatment
Group I: Double-Blind Randomized PlaceboExperimental Treatment1 Intervention
Participants with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) and/or Myofascial Pelvic Pain (MPP) will be randomized to take 8 weeks of Metoprolol Tartrate Oral Tablet or Placebo Oral Tablet, followed by a 4-Week washout period, and then 8 weeks of Placebo or Metoprolol. This intervention aims at finding if subjects with IC/BPS have higher baseline HR compared to HCs. After 4 weeks baseline, subjects will receive a bottle with capsules containing 25 mg of metoprolol tartrate or placebo distributed in a double-blind manner by each site's investigational pharmacy. Subjects will start at 25 mg once daily and increase to the goal dose of 25 mg 2/day after one week, if HR has not decreased below 55 bpm at rest. Subjects will report daily rest HR for the first week. The subjects will then washout for 4 weeks and enter crossover in similar manner.
Group II: Double-Blind Randomized DrugExperimental Treatment1 Intervention
Participants with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) and/or Myofascial Pelvic Pain (MPP) will be randomized to take 8 weeks of Metoprolol Tartrate Oral Tablet or Placebo Oral Tablet, followed by a 4-Week washout period, and then 8 weeks of Placebo or Metoprolol. This intervention aims at finding if subjects with IC/BPS have higher baseline HR compared to HCs. After 4 weeks baseline, subjects will receive a bottle with capsules containing 25 mg of metoprolol tartrate or placebo distributed in a double-blind manner by each site's investigational pharmacy. Subjects will start at 25 mg once daily and increase to the goal dose of 25 mg 2/day after one week, if HR has not decreased below 55 bpm at rest. Subjects will report daily rest HR for the first week. The subjects will then washout for 4 weeks and enter crossover in similar manner.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metoprolol Tartrate Oral Tablet
2021
Completed Phase 4
~140
Placebo Oral Tablet
2017
Completed Phase 4
~2250

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
607 Previous Clinical Trials
1,162,486 Total Patients Enrolled
Case Western Reserve UniversityOTHER
299 Previous Clinical Trials
260,011 Total Patients Enrolled
1 Trials studying Myofascial Pelvic Pain
200 Patients Enrolled for Myofascial Pelvic Pain
NorthShore University HealthSystemOTHER
132 Previous Clinical Trials
737,780 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~10 spots leftby Mar 2025