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A Multiple-Dose Study to Evaluate Skin Irritation and Sensitization of Teriparatide Administered Transdermally in Healthy Postmenopausal Women

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ClinicalTrials.gov Identifier: NCT01250145
Recruitment Status : Completed
First Posted : November 30, 2010
Results First Posted : October 23, 2012
Last Update Posted : October 23, 2012
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Osteoporosis, Postmenopausal
Interventions Drug: LY333334
Drug: Placebo
Enrollment 251
Recruitment Details  
Pre-assignment Details  
Arm/Group Title LY333334 + Placebo: Part A LY333334 + Placebo: Part B
Hide Arm/Group Description

Part A:

Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days

Part B:

Induction phase: Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks

Rest phase: 2 weeks with no patch application

Challenge phase: 80 microgram active patch given once for at least 6 hours

Period Title: Overall Study
Started 41 210
Completed 39 205
Not Completed 2 5
Reason Not Completed
Adverse Event             2             1
Withdrawal by Subject             0             4
Arm/Group Title LY333334 + Placebo: Part A LY333334 + Placebo: Part B Total
Hide Arm/Group Description

Part A:

Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days

Part B:

Induction phase: Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks

Rest phase: 2 weeks with no patch application

Challenge phase: 80 microgram active patch given once for at least 6 hours

Total of all reporting groups
Overall Number of Baseline Participants 41 210 251
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants 210 participants 251 participants
60.2  (8.1) 59.9  (6.7) 59.9  (7.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 210 participants 251 participants
Female
41
 100.0%
210
 100.0%
251
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 210 participants 251 participants
American Indian or Alaska Native
0
   0.0%
1
   0.5%
1
   0.4%
Asian
1
   2.4%
4
   1.9%
5
   2.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   2.4%
0
   0.0%
1
   0.4%
White
38
  92.7%
201
  95.7%
239
  95.2%
More than one race
1
   2.4%
4
   1.9%
5
   2.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 41 participants 210 participants 251 participants
United States 41 33 74
Germany 0 103 103
United Kingdom 0 74 74
1.Primary Outcome
Title Part A - Cumulative Skin Irritation by Draize Score
Hide Description Number of evaluation points (patches) showing defined Draize score. Erythema and edema were used to determine skin irritation. Score 0 = No Erythema/Edema; Score 1 = Very slight Erythema/Edema (barely perceptible); Score 2 = Well defined Erythema/Edema (edges of area well defined by definite raising); Score 3 = Moderate to Severe Erythema/Edema (raised approximately 1 millimeter [mm]).
Time Frame Day 1 through Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who entered the study and received patches are included in the analysis.
Arm/Group Title Part A: Active Patch - Prior to Patch Application Part A: Active Patch - 1 Hour Post Patch Removal Part A: Active Patch - 24 Hours Post Patch Application Part A: Placebo Patch - Prior to Patch Application Part A: Placebo Patch - 1 Hour Post Patch Removal Part A: Placebo Patch - 24 Hours Post Patch Application
Hide Arm/Group Description:
Part A: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores prior to patch application.
Part A: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores 1 hour after patch removal.
Part A: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores 24 hours after patch application.
Part A: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores prior to patch application.
Part A: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores 1 hour after patch removal.
Part A: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores 24 hours after patch application.
Overall Number of Participants Analyzed 41 41 41 41 41 41
Overall Number of Units Analyzed
Type of Units Analyzed: Patches
888 890 887 888 890 887
Measure Type: Number
Unit of Measure: patches with Draize scores
Erythema: Score 0 299 40 146 390 69 205
Erythema: Score 1 523 674 633 452 713 601
Erythema: Score 2 65 176 106 45 108 79
Erythema: Score 3 1 0 2 1 0 2
Edema: Score 0 604 113 370 716 298 539
Edema: Score 1 270 600 454 166 511 322
Edema: Score 2 13 175 62 5 80 26
Edema: Score 3 1 1 1 1 0 0
2.Primary Outcome
Title Part B - Skin Irritation and Sensitization by Draize Score
Hide Description Number of evaluation points (patches) showing defined Draize score. Erythema and edema were used to determine skin irritation and sensitization. Score 0 = No Erythema/Edema; Score 1 = Very slight Erythema/Edema (barely perceptible); Score 2 = Well defined Erythema/Edema (edges of area well defined by definite raising); Score 3 = Moderate to Severe Erythema/Edema (raised approximately 1 mm); Score 4 = Severe Edema (raised more than 1 mm and extending beyond area of exposure).
Time Frame Days 1 - 19 and 34 - 37
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who entered the study and received patches are included in the analysis.
Arm/Group Title Part B: Active Patch - Prior to Patch Application Part B: Active Patch - 1 Hour Post Patch Removal Part B: Active Patch - 24 Hours Post Patch Application Part B: Placebo Patch - Prior to Patch Application Part B: Placebo Patch - 1 Hour Post Patch Removal Part B: Placebo Patch - 24 Hours Post Patch Application
Hide Arm/Group Description:
Part B: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks. Scores prior to patch application.
Part B: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks. Scores 1 hour after patch removal.
Part B: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks. Scores 24 hours after patch application.
Part B: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks. Scores prior to patch application.
Part B: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks. Scores 1 hour after patch removal.
Part B: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks. Scores 24 hours after patch application.
Overall Number of Participants Analyzed 210 210 210 210 210 210
Overall Number of Units Analyzed
Type of Units Analyzed: Patches
2479 2479 2474 2474 2474 2469
Measure Type: Number
Unit of Measure: patches with Draize scores
Erythema: Score 0 1399 122 436 1525 271 784
Erythema: Score 1 1050 1503 1899 924 1698 1578
Erythema: Score 2 30 840 138 25 495 107
Erythema: Score 3 0 14 1 0 10 0
Edema: Score 0 2280 930 1759 2330 1572 2014
Edema: Score 1 197 1141 661 143 766 435
Edema: Score 2 2 399 53 1 136 19
Edema: Score 3 0 5 1 0 0 1
Edema: Score 4 0 4 0 0 0 0
3.Secondary Outcome
Title Part A - Patch Adhesion Score
Hide Description Number of patches with adhesion score. Score 0 = ≥90% adhered (essentially no lift off the skin); Score 1= ≥75% to <90% adhered (some edges only lifting off the skin); Score 2 = ≥50% to <75% adhered (less than half of the patch lifting off the skin); Score 3 = >0% to <50% adhered but not detached (more than half of the patch lifting off the skin without falling off); Score 4 = 0% adhered - patch detached (patch completely off the skin).
Time Frame Day 1 through Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received a patch.
Arm/Group Title Active Patch Placebo Patch
Hide Arm/Group Description:
Part A: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days
Part A: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days
Overall Number of Participants Analyzed 41 41
Overall Number of Units Analyzed
Type of Units Analyzed: Patches
889 889
Measure Type: Number
Unit of Measure: patches with adhesive score
Score 0 879 882
Score 1 8 7
Score 2 1 0
Score 3 0 0
Score 4 1 0
4.Secondary Outcome
Title Part B - Patch Adhesion Score
Hide Description Number of patches with adhesion score. Score 0 = ≥90% adhered (essentially no lift off the skin); Score 1= ≥75% to <90% adhered (some edges only lifting off the skin); Score 2 = ≥50% to <75% adhered (less than half of the patch lifting off the skin); Score 3 = >0% to <50% adhered but not detached (more than half of the patch lifting off the skin without falling off); Score 4 = 0% adhered - patch detached (patch completely off the skin).
Time Frame Days 1 - 19 and 34 - 37
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received a patch.
Arm/Group Title Active Patch Placebo Patch
Hide Arm/Group Description:

Part B: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks.

Rest phase: 2 weeks with no patch application

Challenge phase: 80 microgram active patch given once for at least 6 hours

Part B: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks.

Rest phase: 2 weeks with no patch application

Challenge phase: placebo patch given once for at least 6 hours

Overall Number of Participants Analyzed 210 210
Overall Number of Units Analyzed
Type of Units Analyzed: Patches
2683 2678
Measure Type: Number
Unit of Measure: patches with adhesive score
Score 0 2608 2608
Score 1 40 31
Score 2 13 17
Score 3 9 17
Score 4 13 5
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LY333334 + Placebo: Part A LY333334 + Placebo: Part B
Hide Arm/Group Description

Part A:

Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days

Part B:

Induction phase: Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks

Rest phase: 2 weeks with no patch application

Challenge phase: 80 microgram active patch given once for at least 6 hours

All-Cause Mortality
LY333334 + Placebo: Part A LY333334 + Placebo: Part B
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
LY333334 + Placebo: Part A LY333334 + Placebo: Part B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/41 (0.00%)      2/210 (0.95%)    
Gastrointestinal disorders     
Gastrooesophageal reflux disease  1  0/41 (0.00%)  0 1/210 (0.48%)  1
Injury, poisoning and procedural complications     
Wrist fracture  1  0/41 (0.00%)  0 1/210 (0.48%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LY333334 + Placebo: Part A LY333334 + Placebo: Part B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   31/41 (75.61%)      157/210 (74.76%)    
Gastrointestinal disorders     
Nausea  1  0/41 (0.00%)  0 17/210 (8.10%)  18
Constipation  1  8/41 (19.51%)  9 0/210 (0.00%)  0
General disorders     
Application site erythema  1  0/41 (0.00%)  0 31/210 (14.76%)  79
Application site pain  1  4/41 (9.76%)  6 12/210 (5.71%)  19
Application site pruritus  1  11/41 (26.83%)  25 33/210 (15.71%)  88
Fatigue  1  0/41 (0.00%)  0 13/210 (6.19%)  13
Application site erosion  1  8/41 (19.51%)  11 0/210 (0.00%)  0
Application site vesicles  1  3/41 (7.32%)  4 0/210 (0.00%)  0
Nasal congestion  1  3/41 (7.32%)  3 0/210 (0.00%)  0
Infections and infestations     
Nasopharyngitis  1  0/41 (0.00%)  0 11/210 (5.24%)  11
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/41 (0.00%)  0 12/210 (5.71%)  14
Nervous system disorders     
Headache  1  5/41 (12.20%)  9 53/210 (25.24%)  74
Respiratory, thoracic and mediastinal disorders     
Cough  1  3/41 (7.32%)  3 13/210 (6.19%)  17
Vascular disorders     
Hot flush  1  3/41 (7.32%)  3 0/210 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01250145     History of Changes
Other Study ID Numbers: 13764
I2Y-EW-GHFO ( Other Identifier: Eli Lilly and Company )
First Submitted: November 29, 2010
First Posted: November 30, 2010
Results First Submitted: September 21, 2012
Results First Posted: October 23, 2012
Last Update Posted: October 23, 2012