NCT03029845

Brief Summary

The purpose of the study to evaluate the feasibility of using low dose propranolol for people with fibromyalgia.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 24, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

August 23, 2018

Status Verified

August 1, 2018

Enrollment Period

1.2 years

First QC Date

January 18, 2017

Last Update Submit

August 21, 2018

Conditions

Fibromyalgia Pain

Outcome Measures

Primary Outcomes (1)

  • Change in self-reported measures of clinical pain using Fibromyalgia Impact Questionnaire - Revised (FIQ-R)

    Changes in clinical pain will be measured

    Pre (one week before start taking propranolol or placebo) and Post (immediately following the 14-day trial)

Secondary Outcomes (1)

  • Change in self-reported measures of Fibromyalgia symptoms using Promis Fatigue

    Pre (one week before start taking propranolol or placebo) and Post (immediately following the 14-day trial)

Study Arms (3)

propranolol 1

ACTIVE COMPARATOR

20 mg propranolol twice a day

Drug: Propranolol 1

propranolol 2

ACTIVE COMPARATOR

10 mg propranolol twice a day

Drug: Propranolol 2

Placebo

PLACEBO COMPARATOR

Placebo twice a day

Drug: Placebo

Interventions

Propranolol 1DRUG

Participants will take 20 mg propranolol twice a day for 2 weeks

Also known as: 20 mg propranolol
propranolol 1
Propranolol 2DRUG

Participants will take 10 mg propranolol twice a day for 2 weeks

Also known as: 10 mg propranolol
propranolol 2
PlaceboDRUG

Participants will take placebo twice a day for 2 weeks

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Females with fibromyalgia (both meeting 1990 American College of Rheumatology (ACR) FMS criteria and 2010 ACR FMS criteria) age 18-65 with at least 1 year of symptoms and sedentary (exercising less than 120 min per week).

You may not qualify if:

  • General Health Criteria:
  • Uncontrolled/unstable illnesses (physician diagnosed, self-report)
  • Pregnancy or planning to be pregnant in the next year
  • Having Asthma requiring medication treatment including inhaler
  • Type I diabetes or Type II diabetes requiring medical therapy that can lead to hypoglycemia
  • Having acute pain or neuropathic pain
  • Participation in exercise or psychological treatment studies in the past 2 years
  • Having known serious psychopathology: Psychosis, history of inpatient psychiatric admission in the past year, active suicidal intent, history of self-injurious behaviors in the past year, history of recreational IV drug use, substance abuse history in the past year)
  • Cardiovascular Criteria:
  • Having known cardiovascular diseases (self-report, physician diagnosed)
  • Pacemaker
  • Bradycardia (resting heartrate of less than 55 bpm)
  • Resting diastolic BP \< 55 mmHG or systolic BP\<100 mmHG
  • ECG showing prolonged PR interval \> .2 sec
  • ECG showing irregular PR interval
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Interventions

propranolol mustardPropranolol

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Akiko Okifuji, PhD

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 18, 2017

First Posted

January 24, 2017

Study Start

January 1, 2017

Primary Completion

April 1, 2018

Study Completion

July 1, 2018

Last Updated

August 23, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)