Trial Outcomes & Findings for Gene Regulation by Thiazolidinediones (NCT NCT00567593)

NCT ID: NCT00567593

Last Updated: 2016-08-01

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 12 participants
• Primary outcome timeframe: 14 days
• Results posted on: 2016-08-01

Participant Flow

Participant milestones

Measure	Rosiglitazone Rosiglitazone: 8mg tablet once a day for 14 days
Overall Study STARTED	12
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Rosiglitazone Rosiglitazone: 8mg tablet once a day for 14 days
Overall Study Adverse Event	1
Overall Study Physician Decision	1

Baseline Characteristics

Gene Regulation by Thiazolidinediones

Baseline characteristics by cohort

Measure	Rosaglitazone n=12 Participants Rosiglitazone: 8mg tablet once a day for 14 days
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 14 days

Outcome measures

Measure	Rosiglitazone n=10 Participants Rosiglitazone: 8mg tablet once a day for 14 days
PDK4 mRNA Pre-treatment	.776 copies/nL Interval 0.617 to 1.43
PDK4 mRNA Post-treatment	1.30 copies/nL Interval 0.672 to 1.96

Adverse Events

Rosiglitazone

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Rosiglitazone n=12 participants at risk Rosiglitazone: 8mg tablet once a day for 14 days
General disorders fatigue	8.3% 1/12 • Number of events 2 • Adverse events were collected at baseline and during follow-up for up to 30 days after the last administration of study drug.
Gastrointestinal disorders Nausea	25.0% 3/12 • Number of events 5 • Adverse events were collected at baseline and during follow-up for up to 30 days after the last administration of study drug.
General disorders Headache	8.3% 1/12 • Number of events 1 • Adverse events were collected at baseline and during follow-up for up to 30 days after the last administration of study drug.
Gastrointestinal disorders Diarrhea	8.3% 1/12 • Number of events 1 • Adverse events were collected at baseline and during follow-up for up to 30 days after the last administration of study drug.
Skin and subcutaneous tissue disorders pruritis	8.3% 1/12 • Number of events 1 • Adverse events were collected at baseline and during follow-up for up to 30 days after the last administration of study drug.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	8.3% 1/12 • Number of events 1 • Adverse events were collected at baseline and during follow-up for up to 30 days after the last administration of study drug.
Musculoskeletal and connective tissue disorders Tendonitis in R ring finger	8.3% 1/12 • Number of events 2 • Adverse events were collected at baseline and during follow-up for up to 30 days after the last administration of study drug.
Respiratory, thoracic and mediastinal disorders Slight cold	8.3% 1/12 • Number of events 1 • Adverse events were collected at baseline and during follow-up for up to 30 days after the last administration of study drug.

Additional Information

James D. Lewis, MD, MSCE

University of Pennsylvania

Phone: 215-573-5137

Email: lewisjd@mail.med.upenn.edu

Results disclosure agreements

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