Trial Outcomes & Findings for Effect of Exercise in OI (NCT NCT00770484)

NCT ID: NCT00770484

Last Updated: 2016-08-05

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 12 participants
• Primary outcome timeframe: Over approximately 30 minutes, within 2 hours of receiving each intervention.
• Results posted on: 2016-08-05

Participant Flow

Participant milestones

Measure	Propranolol Then Placebo Active treatment Propranolol then Placebo: Propanolol 20 mg, given orally within 1 hour prior to exercising	Placebo Then Propranolol Placebo Treatment Placebo then Propranolol: Placebo, matching pill given orally within 1 hour prior to exercising
Overall Study STARTED	8	4
Overall Study COMPLETED	7	4
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Propranolol Then Placebo Active treatment Propranolol then Placebo: Propanolol 20 mg, given orally within 1 hour prior to exercising	Placebo Then Propranolol Placebo Treatment Placebo then Propranolol: Placebo, matching pill given orally within 1 hour prior to exercising
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Effect of Exercise in OI

Baseline characteristics by cohort

Measure	Propranolol Then Placebo n=8 Participants Active treatment Propranolol then Placebo: Propanolol 20 mg, given orally within 1 hour prior to exercising	Placebo Then Propranolol n=4 Participants Placebo Treatment Placebo then Propranolol: Placebo, matching pill given orally within 1 hour prior to exercising	Total n=12 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	31 Years STANDARD_DEVIATION 3 • n=5 Participants	32 Years STANDARD_DEVIATION 2 • n=7 Participants	32 Years STANDARD_DEVIATION 3 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	4 participants n=7 Participants	12 participants n=5 Participants

PRIMARY outcome

Timeframe: Over approximately 30 minutes, within 2 hours of receiving each intervention.

Outcome measures

Measure	Propranolol n=11 Participants Active treatment Propranolol then Placebo: Propanolol 20 mg, given orally within 1 hour prior to exercising	Placebo n=11 Participants Placebo Treatment Placebo then Propranolol: Placebo, matching pill given orally within 1 hour prior to exercising
Maximal Oxygen Consumption Capacity (VO2 Max)	27.6 mL/kg/min Standard Error 1	24.5 mL/kg/min Standard Error 0.7

Adverse Events

Propranolol Then Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Then Propranolol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Italo Biaggioni, MD., Professor of Medicine and Pharmacology

Vanderbilt University

Phone: (615) 936-3420

Email: italo.biaggioni@vanderbilt.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place