Trial Outcomes & Findings for Levothyroxine Replacement With Liquid Gel Capsules vs Tablets Post-thyroidectomy (NCT NCT02946918)
NCT ID: NCT02946918
Last Updated: 2020-12-01
Results Overview
The target TSH (Thyroid stimulating hormone) range will be 0.1 to 0.5 mU/L. The number of patients in each arm (gelcaps or tablets) who are in this range at the completion of the study (18 weeks) will be assessed and the data compared at completion of the study.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
14 participants
Primary outcome timeframe
18 weeks
Results posted on
2020-12-01
Participant Flow
Participant milestones
| Measure |
Tablets
Patients in this arm will receive levothyroxine tablets (encapsulated for blinding purposes)
Levothyroxine: Patients post-thyroidectomy will receive either levothyroxine in tablet form or in gelcaps
|
Gelcaps
Patients in this arm will receive levothyroxine gelcaps (encapsulated for blinding purposes)
Levothyroxine: Patients post-thyroidectomy will receive either levothyroxine in tablet form or in gelcaps
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
8
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
Tablets
Patients in this arm will receive levothyroxine tablets (encapsulated for blinding purposes)
Levothyroxine: Patients post-thyroidectomy will receive either levothyroxine in tablet form or in gelcaps
|
Gelcaps
Patients in this arm will receive levothyroxine gelcaps (encapsulated for blinding purposes)
Levothyroxine: Patients post-thyroidectomy will receive either levothyroxine in tablet form or in gelcaps
|
|---|---|---|
|
Overall Study
Patient unblinded himself
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
2
|
|
Overall Study
Ran out of study medication
|
0
|
1
|
Baseline Characteristics
Levothyroxine Replacement With Liquid Gel Capsules vs Tablets Post-thyroidectomy
Baseline characteristics by cohort
| Measure |
Tablets
n=6 Participants
Patients in this arm will receive levothyroxine tablets (encapsulated for blinding purposes)
Levothyroxine: Patients post-thyroidectomy will receive either levothyroxine in tablet form or in gelcaps
|
Gelcaps
n=8 Participants
Patients in this arm will receive levothyroxine gelcaps (encapsulated for blinding purposes)
Levothyroxine: Patients post-thyroidectomy will receive either levothyroxine in tablet form or in gelcaps
|
Total
n=14 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
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 weeksThe target TSH (Thyroid stimulating hormone) range will be 0.1 to 0.5 mU/L. The number of patients in each arm (gelcaps or tablets) who are in this range at the completion of the study (18 weeks) will be assessed and the data compared at completion of the study.
Outcome measures
| Measure |
Tablets
n=6 Participants
Patients in this arm will receive levothyroxine tablets (encapsulated for blinding purposes)
Levothyroxine: Patients post-thyroidectomy will receive either levothyroxine in tablet form or in gelcaps
|
Gelcaps
n=8 Participants
Patients in this arm will receive levothyroxine gelcaps (encapsulated for blinding purposes)
Levothyroxine: Patients post-thyroidectomy will receive either levothyroxine in tablet form or in gelcaps
|
|---|---|---|
|
Number of Patients in Each Group at Predefined Target TSH Range at 18 Weeks
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 18 weeksThe number of dose adjustments required to attain TSH target range for each formulation will be tabulated and the data compared at the end of the study
Outcome measures
| Measure |
Tablets
n=6 Participants
Patients in this arm will receive levothyroxine tablets (encapsulated for blinding purposes)
Levothyroxine: Patients post-thyroidectomy will receive either levothyroxine in tablet form or in gelcaps
|
Gelcaps
n=8 Participants
Patients in this arm will receive levothyroxine gelcaps (encapsulated for blinding purposes)
Levothyroxine: Patients post-thyroidectomy will receive either levothyroxine in tablet form or in gelcaps
|
|---|---|---|
|
Mean Number of Dose Adjustments
|
2.0 The number of dose adjustments
Standard Deviation 0.63
|
1.25 The number of dose adjustments
Standard Deviation 1.04
|
SECONDARY outcome
Timeframe: Baseline,18 weeksPopulation: Out of 6 people from the Tablet group, 1 did not complete the second survey. Out of 8 people from the Gelcap group, 3 people did not complete the survey.
Patients will be administered survey (Thyroid-Dependent Quality of Life ) to assess their quality of life (at the beginning of the study and again at study completion). The results of these scores will be tabulated and compared between the two arms. Possible score range from 0 to 450; lower score means improved quality of life.
Outcome measures
| Measure |
Tablets
n=5 Participants
Patients in this arm will receive levothyroxine tablets (encapsulated for blinding purposes)
Levothyroxine: Patients post-thyroidectomy will receive either levothyroxine in tablet form or in gelcaps
|
Gelcaps
n=5 Participants
Patients in this arm will receive levothyroxine gelcaps (encapsulated for blinding purposes)
Levothyroxine: Patients post-thyroidectomy will receive either levothyroxine in tablet form or in gelcaps
|
|---|---|---|
|
Change in Mean Patient Quality of Life Score
|
-1.2 score on a scale
Standard Deviation 12.99
|
-29.6 score on a scale
Standard Deviation 48.06
|
SECONDARY outcome
Timeframe: 18 weeksPopulation: Out of 6 people from the Tablet group, 1 did not complete the second survey. Out of 8 people from the Gelcap group, 3 people did not complete the survey.
The Thyroid Treatment Satisfaction Questionnaire Measures the treatment satisfaction. Possible measure 0 to 42; Higher the score, better the outcome (more satisfied the patient)
Outcome measures
| Measure |
Tablets
n=5 Participants
Patients in this arm will receive levothyroxine tablets (encapsulated for blinding purposes)
Levothyroxine: Patients post-thyroidectomy will receive either levothyroxine in tablet form or in gelcaps
|
Gelcaps
n=5 Participants
Patients in this arm will receive levothyroxine gelcaps (encapsulated for blinding purposes)
Levothyroxine: Patients post-thyroidectomy will receive either levothyroxine in tablet form or in gelcaps
|
|---|---|---|
|
Treatment Satisfaction Survey
|
39.2 score on a scale
Standard Deviation 3.70
|
39 score on a scale
Standard Deviation 3
|
Adverse Events
Tablets
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Gelcaps
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tablets
n=6 participants at risk
Patients in this arm will receive levothyroxine tablets (encapsulated for blinding purposes)
Levothyroxine: Patients post-thyroidectomy will receive either levothyroxine in tablet form or in gelcaps
|
Gelcaps
n=8 participants at risk
Patients in this arm will receive levothyroxine gelcaps (encapsulated for blinding purposes)
Levothyroxine: Patients post-thyroidectomy will receive either levothyroxine in tablet form or in gelcaps
|
|---|---|---|
|
Gastrointestinal disorders
GERD
|
16.7%
1/6 • Number of events 1 • 18 weeks (until completion of the study)
All 14 subjects were considered at risk for adverse events
|
0.00%
0/8 • 18 weeks (until completion of the study)
All 14 subjects were considered at risk for adverse events
|
|
Nervous system disorders
anxiety
|
16.7%
1/6 • Number of events 1 • 18 weeks (until completion of the study)
All 14 subjects were considered at risk for adverse events
|
12.5%
1/8 • Number of events 1 • 18 weeks (until completion of the study)
All 14 subjects were considered at risk for adverse events
|
|
Skin and subcutaneous tissue disorders
psoriasis
|
16.7%
1/6 • Number of events 1 • 18 weeks (until completion of the study)
All 14 subjects were considered at risk for adverse events
|
0.00%
0/8 • 18 weeks (until completion of the study)
All 14 subjects were considered at risk for adverse events
|
|
Musculoskeletal and connective tissue disorders
back pain
|
16.7%
1/6 • Number of events 1 • 18 weeks (until completion of the study)
All 14 subjects were considered at risk for adverse events
|
0.00%
0/8 • 18 weeks (until completion of the study)
All 14 subjects were considered at risk for adverse events
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/6 • 18 weeks (until completion of the study)
All 14 subjects were considered at risk for adverse events
|
12.5%
1/8 • Number of events 1 • 18 weeks (until completion of the study)
All 14 subjects were considered at risk for adverse events
|
|
Endocrine disorders
fatigue
|
16.7%
1/6 • Number of events 1 • 18 weeks (until completion of the study)
All 14 subjects were considered at risk for adverse events
|
12.5%
1/8 • Number of events 1 • 18 weeks (until completion of the study)
All 14 subjects were considered at risk for adverse events
|
|
Endocrine disorders
hypocalcemia
|
16.7%
1/6 • Number of events 1 • 18 weeks (until completion of the study)
All 14 subjects were considered at risk for adverse events
|
0.00%
0/8 • 18 weeks (until completion of the study)
All 14 subjects were considered at risk for adverse events
|
|
Skin and subcutaneous tissue disorders
rosacea
|
0.00%
0/6 • 18 weeks (until completion of the study)
All 14 subjects were considered at risk for adverse events
|
12.5%
1/8 • Number of events 1 • 18 weeks (until completion of the study)
All 14 subjects were considered at risk for adverse events
|
Additional Information
Dr. Alex Tessnow-ASSOC PROFESSOR
UT Southwestern Medical Center
Phone: 214/648-3685
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place