Growth Hormone Treatment in Children Born Small for Gestational Age (SGA)
Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT00184717
Collaborator
(none)
98
1
5
64.3
1.5
Study Details
Study Description
Brief Summary
This study is conducted in Japan. The aim of this trial is to assess the efficacy and safety of somatropin in children born small for gestational age (SGA) in Japan.
In the main period, subjects will receive either active treatment for 104 weeks (two dosing regimens) or no treatment for 52 weeks followed by an extension period where subjects who received active treatment for 104 weeks (two years) will continue with the same treatment for further 156 weeks (three years) while those subjects who received no treatment for 52 weeks (one year) will be randomised to receive two dosing regimens for 208 weeks (four years). In total, subjects participate in trial for 260 weeks (five years).
Main period is registered internally at Novo Nordisk as GHLIQUID-1516 while the extension period is registered as GHLIQUID-1517.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
98 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
GHLIQUID-1516: A 104-week, Multi-centre, Randomised, Double-blind, Parallel-group, no Treatment Controlled (Open-label) Trial Investigating the Efficacy and Safety of Two Doses of NN-220 in Subjects With Short Stature Born Small for Gestational Age / GHLIQUID-1517: A Long-term, Multi-centre, Randomised, Controlled, Double-blind, Parallel-group Trial, Investigating the Efficacy and Safety of Two Doses of NN-220 in Subjects With Short Stature Born Small for Gestational Age
Actual Study Start Date
:
Aug 18, 2004
Actual Primary Completion Date
:
Mar 29, 2006
Actual Study Completion Date
:
Dec 28, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 0.033 mg / NN-220 In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime |
Drug: somatropin
0.033 mg/kg/day of NN-220 for s.c. injection in cartridge
|
| Experimental: 0.067 mg / NN-220 In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime |
Drug: somatropin
0.067 mg/kg/day of NN-220 for s.c. injection in cartridge
|
| No Intervention: No treatment No somatropin (NN-220) treatment was given in the 52-week main period. Subjects was re-randomised to recive two dosing regimens (0.033 mg/kg/day or 0.067 mg/kg/day) in the 208-week extension period |
|
| Experimental: No treatment --> 0.033 mg In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period |
Drug: somatropin
0.033 mg/kg/day of NN-220 for s.c. injection in cartridge
|
| Experimental: No treatment --> 0.067 mg In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period |
Drug: somatropin
0.067 mg/kg/day of NN-220 for s.c. injection in cartridge
|
Outcome Measures
Primary Outcome Measures
- Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 260 - Subjects Received NN220 Treatment for 5 Years [Week 0, week 260]
Height SDS for chronological age were derived as follow; {Height - mean (age, sex)}/ SD (age, sex), where mean (age, sex) and SD (age, sex) were mean and SD of height for corresponding chronological age and sex (data of those in 2000). Height SDS was calculated using mean of three height observations at corresponding visit
- Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 208 - Subjects Received NN220 Treatment for 4 Years [Week 0, week 208]
Height SDS for chronological age were derived as follow; {Height - mean (age, sex)}/ SD (age, sex), where mean (age, sex) and SD (age, sex) were mean and SD of height for corresponding chronological age and sex (data of those in 2000). Height SDS was calculated using mean of three height observations at corresponding visit
Secondary Outcome Measures
- Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 5 Years [Weeks 0-260]
Yearly Height velocity SDS for chronological age were summarised and graphically presented
- Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 4 Years [Weeks 0-208]
Yearly Height velocity SDS for chronological age were summarised and graphically presented
- Change in Bone Age (Left Hand X-Ray) at Week 260 - Subjects Received NN220 Treatment for 5 Years [Week 0, week 260]
Bone age is measured as years and months (displayed as xx.x years). Change in Bone age = Bone age at 52*i weeks - Bone age at 52*(i-1) weeks, i=1, 2, ….
- Change in Bone Age (Left Hand X-Ray) at Week 208 - Subjects Received NN220 Treatment for 4 Years [Week 0, week 208]
Bone age is measured as years and months (displayed as xx.x years).Change in Bone age = Bone age at 52*i weeks - Bone age at 52*(i-1) weeks, i=1, 2, ….
- Adverse Events - Subjects Received NN220 Treatment for 5 Years [Weeks 0-260]
Occurrence of Adverse Events (AEs) during treatment period (TEAEs), occurrence of possibly/probably related AEs during the treatment period, and occurrence of Serious Adverse Events (SAEs) during the treatment period. An AE is any undesirable medical event occurring to a subject in a clinical trial, whether or not related to the trial product(s). An SAE is an experience that at any dose is fatal, life-threatening, disabling or which results in the patient being hospitalised or, if already in hospital, that hospitalisation is prolonged, or ocurrence of congenital anomaly
- Adverse Events - Subjects Received NN220 Treatment for 4 Years [Weeks 0-208]
Occurrence of Adverse Events (AEs) during treatment period (TEAEs), occurrence of possibly/probably related AEs during the treatment period, and occurrence of Serious Adverse Events (SAEs) during the treatment period. An AE is any undesirable medical event occurring to a subject in a clinical trial, whether or not related to the trial product(s). An SAE is an experience that at any dose is fatal, life-threatening, disabling or which results in the patient being hospitalised or, if already in hospital, that hospitalisation is prolonged, or ocurrence of congenital anomaly
Eligibility Criteria
Criteria
Ages Eligible for Study:
3 Years
to 8 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
For MAIN period (GHLIQUID-1516):
-
Born small for gestational age (SGA) with birth weight and birth length below the 10th percentile for gestational age, and additional either birth length below or equal to -2.0 standard deviation score (SDS) or birth weight below or equal to -2.0 SDS for gestational age
-
Growth failure with height at -2.0 SDS or below for chronological age (CA)
-
Normal growth hormone (GH) production, defined as peak GH level > 10 ng/mL in one GH provocation test
-
For EXTENSION period (GHLIQUID-1517):
-
Subjects who completed the main period
-
Chronological age (CA) for boys at least 4 years, but maximum 11 years
-
Chronological age (CA) for girls at least 4 years, but maximum 10 years
Exclusion Criteria:
-
Subjects with diabetes mellitus
-
Subjects suffering from malignancy
-
Several medical conditions
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novo Nordisk Investigational Site | Tokyo | Japan | 1000005 |
Sponsors and Collaborators
- Novo Nordisk A/S
Investigators
- Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00184717
Other Study ID Numbers:
- GHLIQUID-1517
- JapicCTI-050137
- JapicCTI-050132
- 2017-000914-47
- NCT00184704
First Posted:
Sep 16, 2005
Last Update Posted:
Jul 7, 2017
Last Verified:
Jun 1, 2017
Study Results
Participant Flow
| Recruitment Details | 44 sites in Japan |
|---|---|
| Pre-assignment Detail | Subjects completed the main period and were offered to continue in the extension period. |
| Arm/Group Title | 0.033 mg / NN-220 | 0.067 mg / NN-220 | No Treatment | No Treatment --> 0.033 mg | No Treatment --> 0.067 mg |
|---|---|---|---|---|---|
| Arm/Group Description | In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime | In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime | No somatropin (NN-220) treatment was given in the 52-week main period. Subjects was re-randomised to recive two dosing regimens (0.033 mg/kg/day or 0.067 mg/kg/day) in the 208-week extension period | In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period | In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period |
| Period Title: Main Period (GHLIQUID-1516) | |||||
| STARTED | 39 | 38 | 21 | 0 | 0 |
| Exposed to Trial Drug | 38 | 38 | 21 | 0 | 0 |
| COMPLETED | 36 | 36 | 20 | 0 | 0 |
| NOT COMPLETED | 3 | 2 | 1 | 0 | 0 |
| Period Title: Main Period (GHLIQUID-1516) | |||||
| STARTED | 33 | 33 | 0 | 10 | 10 |
| COMPLETED | 23 | 27 | 0 | 7 | 5 |
| NOT COMPLETED | 10 | 6 | 0 | 3 | 5 |
Baseline Characteristics
| Arm/Group Title | 0.033 mg / NN-220 | 0.067 mg / NN-220 | No Treatment | Total |
|---|---|---|---|---|
| Arm/Group Description | In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime | In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime | No somatropin (NN-220) treatment was given in the 52-week main period. Subjects was re-randomised to recive two dosing regimens (0.033 mg/kg/day or 0.067 mg/kg/day) in the 208-week extension period | Total of all reporting groups |
| Overall Participants | 35 | 34 | 15 | 84 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
5.46
(1.37)
|
5.15
(1.2)
|
5.09
(1.37)
|
5.27
(1.3)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
11
31.4%
|
14
41.2%
|
8
53.3%
|
33
39.3%
|
| Male |
24
68.6%
|
20
58.8%
|
7
46.7%
|
51
60.7%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
35
100%
|
34
100%
|
15
100%
|
84
100%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
35
100%
|
34
100%
|
15
100%
|
84
100%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| White |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | ||||
| Japan |
35
100%
|
34
100%
|
15
100%
|
84
100%
|
| Height (cm) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [cm] |
96.19
(8.48)
|
94.57
(7.28)
|
94.42
(8.48)
|
95.22
(7.96)
|
| Body weight (kg) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [kg] |
13.31
(2.55)
|
12.62
(1.81)
|
12.47
(2.93)
|
12.88
(2.36)
|
Outcome Measures
| Title | Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 260 - Subjects Received NN220 Treatment for 5 Years |
|---|---|
| Description | Height SDS for chronological age were derived as follow; {Height - mean (age, sex)}/ SD (age, sex), where mean (age, sex) and SD (age, sex) were mean and SD of height for corresponding chronological age and sex (data of those in 2000). Height SDS was calculated using mean of three height observations at corresponding visit |
| Time Frame | Week 0, week 260 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity |
| Arm/Group Title | 0.033 mg / NN-220 | 0.067 mg / NN-220 | No Treatment --> 0.033 mg | No Treatment --> 0.067 mg |
|---|---|---|---|---|
| Arm/Group Description | In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime | In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime | In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period | In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period |
| Measure Participants | 28 | 29 | 0 | 0 |
| Week 0 |
-2.9488
(0.6368)
|
-2.9047
(0.6718)
|
||
| Week 260 |
1.2066
(0.1102)
|
2.0247
(0.1083)
|
| Title | Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 208 - Subjects Received NN220 Treatment for 4 Years |
|---|---|
| Description | Height SDS for chronological age were derived as follow; {Height - mean (age, sex)}/ SD (age, sex), where mean (age, sex) and SD (age, sex) were mean and SD of height for corresponding chronological age and sex (data of those in 2000). Height SDS was calculated using mean of three height observations at corresponding visit |
| Time Frame | Week 0, week 208 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity |
| Arm/Group Title | 0.033 mg / NN-220 | 0.067 mg / NN-220 | No Treatment --> 0.033 mg | No Treatment --> 0.067 mg |
|---|---|---|---|---|
| Arm/Group Description | In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime | In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime | In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period | In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period |
| Measure Participants | 0 | 0 | 7 | 8 |
| Week 0 |
-2.9603
(0.6689)
|
-2.7481
(0.3524)
|
||
| Week 208 |
1.0997
(0.2453)
|
1.9151
(0.2275)
|
| Title | Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 5 Years |
|---|---|
| Description | Yearly Height velocity SDS for chronological age were summarised and graphically presented |
| Time Frame | Weeks 0-260 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity |
| Arm/Group Title | 0.033 mg / NN-220 | 0.067 mg / NN-220 | No Treatment --> 0.033 mg | No Treatment --> 0.067 mg |
|---|---|---|---|---|
| Arm/Group Description | In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime | In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime | In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period | In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period |
| Measure Participants | 31 | 34 | 0 | 0 |
| Baseline, n=31, 34 |
-1.6299
(0.9738)
|
-2.0303
(1.4527)
|
||
| Week 52, n=29, 34 |
2.4717
(1.9848)
|
4.7875
(1.9365)
|
||
| Week 104, n=29, 32 |
1.1344
(1.2782)
|
2.8877
(1.1272)
|
||
| Week 156, n=25, 29 |
0.8015
(1.0583)
|
2.1641
(1.5929)
|
||
| Week 208, n=25, 28 |
0.3991
(1.3006)
|
1.4724
(1.8696)
|
||
| Week 260, n=23, 27 |
0.4612
(2.1558)
|
0.7973
(2.1822)
|
| Title | Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 4 Years |
|---|---|
| Description | Yearly Height velocity SDS for chronological age were summarised and graphically presented |
| Time Frame | Weeks 0-208 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity |
| Arm/Group Title | 0.033 mg / NN-220 | 0.067 mg / NN-220 | No Treatment --> 0.033 mg | No Treatment --> 0.067 mg |
|---|---|---|---|---|
| Arm/Group Description | In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime | In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime | In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period | In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period |
| Measure Participants | 0 | 0 | 7 | 8 |
| Baseline, n=7,8 |
0.073
(1.5681)
|
-1.356
(0.708)
|
||
| Week 52, n=7, 8 |
2.1677
(0.61)
|
5.9303
(1.2096)
|
||
| Week 104, n=6, 7 |
1.5268
(1.1715)
|
3.3979
(1.0542)
|
||
| Week 156, n=6, 7 |
1.7617
(2.0956)
|
2.3539
(1.3149)
|
||
| Week 208, n=6, 6 |
0.5475
(1.6055)
|
2.199
(1.5973)
|
| Title | Change in Bone Age (Left Hand X-Ray) at Week 260 - Subjects Received NN220 Treatment for 5 Years |
|---|---|
| Description | Bone age is measured as years and months (displayed as xx.x years). Change in Bone age = Bone age at 52*i weeks - Bone age at 52*(i-1) weeks, i=1, 2, …. |
| Time Frame | Week 0, week 260 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity |
| Arm/Group Title | 0.033 mg / NN-220 | 0.067 mg / NN-220 | No Treatment --> 0.033 mg | No Treatment --> 0.067 mg |
|---|---|---|---|---|
| Arm/Group Description | In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime | In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime | In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period | In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period |
| Measure Participants | 21 | 26 | 0 | 0 |
| Mean (Standard Deviation) [years] |
5.79
(1.05)
|
7.15
(1.05)
|
| Title | Change in Bone Age (Left Hand X-Ray) at Week 208 - Subjects Received NN220 Treatment for 4 Years |
|---|---|
| Description | Bone age is measured as years and months (displayed as xx.x years).Change in Bone age = Bone age at 52*i weeks - Bone age at 52*(i-1) weeks, i=1, 2, …. |
| Time Frame | Week 0, week 208 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity |
| Arm/Group Title | 0.033 mg / NN-220 | 0.067 mg / NN-220 | No Treatment --> 0.033 mg | No Treatment --> 0.067 mg |
|---|---|---|---|---|
| Arm/Group Description | In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime | In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime | In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period | In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period |
| Measure Participants | 0 | 0 | 5 | 6 |
| Mean (Standard Deviation) [years] |
6.54
(1.26)
|
5.6
(1.68)
|
| Title | Adverse Events - Subjects Received NN220 Treatment for 5 Years |
|---|---|
| Description | Occurrence of Adverse Events (AEs) during treatment period (TEAEs), occurrence of possibly/probably related AEs during the treatment period, and occurrence of Serious Adverse Events (SAEs) during the treatment period. An AE is any undesirable medical event occurring to a subject in a clinical trial, whether or not related to the trial product(s). An SAE is an experience that at any dose is fatal, life-threatening, disabling or which results in the patient being hospitalised or, if already in hospital, that hospitalisation is prolonged, or ocurrence of congenital anomaly |
| Time Frame | Weeks 0-260 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity |
| Arm/Group Title | 0.033 mg / NN-220 | 0.067 mg / NN-220 | No Treatment --> 0.033 mg | No Treatment --> 0.067 mg |
|---|---|---|---|---|
| Arm/Group Description | In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime | In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime | In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period | In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period |
| Measure Participants | 31 | 34 | 0 | 0 |
| AEs |
31
|
34
|
||
| AEs possibly/probably related |
9
|
16
|
||
| SAEs |
2
|
4
|
| Title | Adverse Events - Subjects Received NN220 Treatment for 4 Years |
|---|---|
| Description | Occurrence of Adverse Events (AEs) during treatment period (TEAEs), occurrence of possibly/probably related AEs during the treatment period, and occurrence of Serious Adverse Events (SAEs) during the treatment period. An AE is any undesirable medical event occurring to a subject in a clinical trial, whether or not related to the trial product(s). An SAE is an experience that at any dose is fatal, life-threatening, disabling or which results in the patient being hospitalised or, if already in hospital, that hospitalisation is prolonged, or ocurrence of congenital anomaly |
| Time Frame | Weeks 0-208 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity |
| Arm/Group Title | 0.033 mg / NN-220 | 0.067 mg / NN-220 | No Treatment --> 0.033 mg | No Treatment --> 0.067 mg |
|---|---|---|---|---|
| Arm/Group Description | In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime | In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime | In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period | In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period |
| Measure Participants | 0 | 0 | 7 | 8 |
| AEs |
7
|
8
|
||
| AEs possibly/probably relate |
1
|
3
|
||
| SAEs |
0
|
1
|
Adverse Events
| Time Frame | The adverse events were collected from Aug 2004 to Dec 2009. | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity. | |||||||
| Arm/Group Title | 0.033 mg / NN-220 | 0.067 mg / NN-220 | 0.033 mg / No Treatment | 0.067 mg / No Treatment | ||||
| Arm/Group Description | ||||||||
All Cause Mortality |
||||||||
| 0.033 mg / NN-220 | 0.067 mg / NN-220 | 0.033 mg / No Treatment | 0.067 mg / No Treatment | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| 0.033 mg / NN-220 | 0.067 mg / NN-220 | 0.033 mg / No Treatment | 0.067 mg / No Treatment | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 12/31 (38.7%) | 11/34 (32.4%) | 1/7 (14.3%) | 2/8 (25%) | ||||
| Congenital, familial and genetic disorders | ||||||||
| Sebaceous naevus | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Eye disorders | ||||||||
| Strabismus | 2/31 (6.5%) | 2 | 1/34 (2.9%) | 2 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Gastrointestinal disorders | ||||||||
| Ileus | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Inguinal hernia | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Infections and infestations | ||||||||
| Bronchitis | 1/31 (3.2%) | 2 | 0/34 (0%) | 0 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Bronchopneumonia | 1/31 (3.2%) | 3 | 0/34 (0%) | 0 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Campylobacter gastroenteritis | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Epstein-Barr virus infection | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Gastroenteritis rotavirus | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Gastroenteritis viral | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/7 (14.3%) | 1 | 1/8 (12.5%) | 1 |
| Impetigo | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/7 (0%) | 0 | 1/8 (12.5%) | 1 |
| Influenza | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Laryngitis | 0/31 (0%) | 0 | 1/34 (2.9%) | 3 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Meningitis aseptic | 0/31 (0%) | 0 | 2/34 (5.9%) | 2 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Mumps | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Otitis media | 0/31 (0%) | 0 | 1/34 (2.9%) | 2 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Pneumonia | 2/31 (6.5%) | 2 | 1/34 (2.9%) | 1 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Pneumonia mycoplasmal | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Postoperative wound infection | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Streptococcal infection | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Tracheobronchitis mycoplasmal | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||
| Humerus fracture | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Joint dislocation | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||
| Torticollis | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Nervous system disorders | ||||||||
| Convulsion | 2/31 (6.5%) | 2 | 0/34 (0%) | 0 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Febrile convulsion | 2/31 (6.5%) | 3 | 0/34 (0%) | 0 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Renal and urinary disorders | ||||||||
| IgA nephropathy | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Reproductive system and breast disorders | ||||||||
| Testicular retraction | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Adenoidal hypertrophy | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/7 (0%) | 0 | 1/8 (12.5%) | 1 |
| Asthma | 1/31 (3.2%) | 1 | 1/34 (2.9%) | 1 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Sleep apnoea syndrome | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Tonsillar disorder | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Tonsillar hypertrophy | 2/31 (6.5%) | 2 | 0/34 (0%) | 0 | 0/7 (0%) | 0 | 1/8 (12.5%) | 1 |
| Skin and subcutaneous tissue disorders | ||||||||
| Dermatitis atopic | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Urticaria | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Vitiligo | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Vascular disorders | ||||||||
| Aortic stenosis | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||
| 0.033 mg / NN-220 | 0.067 mg / NN-220 | 0.033 mg / No Treatment | 0.067 mg / No Treatment | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 31/31 (100%) | 34/34 (100%) | 7/7 (100%) | 8/8 (100%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Iron deficiency anaemia | 2/31 (6.5%) | 2 | 0/34 (0%) | 0 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Lymphadenitis | 1/31 (3.2%) | 1 | 5/34 (14.7%) | 5 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Lymphadenopathy | 0/31 (0%) | 0 | 2/34 (5.9%) | 2 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Congenital, familial and genetic disorders | ||||||||
| Hydrocele | 0/31 (0%) | 0 | 2/34 (5.9%) | 2 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Ear and labyrinth disorders | ||||||||
| Ear pain | 0/31 (0%) | 0 | 3/34 (8.8%) | 4 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Motion sickness | 1/31 (3.2%) | 5 | 2/34 (5.9%) | 2 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Eye disorders | ||||||||
| Astigmatism | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 1/7 (14.3%) | 1 | 1/8 (12.5%) | 1 |
| Conjunctival hyperaemia | 2/31 (6.5%) | 2 | 0/34 (0%) | 0 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Conjunctivitis | 4/31 (12.9%) | 4 | 7/34 (20.6%) | 13 | 0/7 (0%) | 0 | 3/8 (37.5%) | 4 |
| Conjunctivitis allergic | 3/31 (9.7%) | 5 | 5/34 (14.7%) | 7 | 0/7 (0%) | 0 | 2/8 (25%) | 3 |
| Eye pain | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/7 (0%) | 0 | 1/8 (12.5%) | 1 |
| Eyelid oedema | 2/31 (6.5%) | 2 | 0/34 (0%) | 0 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Myopia | 1/31 (3.2%) | 1 | 2/34 (5.9%) | 2 | 1/7 (14.3%) | 1 | 0/8 (0%) | 0 |
| Strabismus | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 1/7 (14.3%) | 1 | 0/8 (0%) | 0 |
| Gastrointestinal disorders | ||||||||
| Abdominal pain | 4/31 (12.9%) | 4 | 2/34 (5.9%) | 3 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Constipation | 6/31 (19.4%) | 8 | 5/34 (14.7%) | 7 | 0/7 (0%) | 0 | 2/8 (25%) | 3 |
| Dental caries | 2/31 (6.5%) | 2 | 6/34 (17.6%) | 7 | 0/7 (0%) | 0 | 2/8 (25%) | 2 |
| Diarrhoea | 2/31 (6.5%) | 3 | 4/34 (11.8%) | 5 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Dyspepsia | 1/31 (3.2%) | 1 | 2/34 (5.9%) | 4 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Enterocolitis | 2/31 (6.5%) | 8 | 1/34 (2.9%) | 1 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Stomatitis | 1/31 (3.2%) | 1 | 3/34 (8.8%) | 4 | 0/7 (0%) | 0 | 1/8 (12.5%) | 1 |
| Toothache | 0/31 (0%) | 0 | 2/34 (5.9%) | 2 | 1/7 (14.3%) | 1 | 1/8 (12.5%) | 2 |
| Vomiting | 7/31 (22.6%) | 7 | 4/34 (11.8%) | 6 | 0/7 (0%) | 0 | 2/8 (25%) | 2 |
| General disorders | ||||||||
| Fatigue | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/7 (0%) | 0 | 1/8 (12.5%) | 5 |
| Pyrexia | 10/31 (32.3%) | 17 | 10/34 (29.4%) | 23 | 0/7 (0%) | 0 | 1/8 (12.5%) | 1 |
| Hepatobiliary disorders | ||||||||
| Hepatic function abnormal | 1/31 (3.2%) | 2 | 2/34 (5.9%) | 2 | 0/7 (0%) | 0 | 2/8 (25%) | 4 |
| Immune system disorders | ||||||||
| Food allergy | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/7 (0%) | 0 | 1/8 (12.5%) | 1 |
| Seasonal allergy | 1/31 (3.2%) | 1 | 1/34 (2.9%) | 1 | 1/7 (14.3%) | 3 | 0/8 (0%) | 0 |
| Infections and infestations | ||||||||
| Acute sinusitis | 1/31 (3.2%) | 1 | 2/34 (5.9%) | 8 | 0/7 (0%) | 0 | 1/8 (12.5%) | 2 |
| Acute tonsillitis | 2/31 (6.5%) | 2 | 4/34 (11.8%) | 11 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Adenoviral conjunctivitis | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/7 (0%) | 0 | 1/8 (12.5%) | 1 |
| Adenovirus infection | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/7 (0%) | 0 | 1/8 (12.5%) | 1 |
| Beta haemolytic streptococcal infection | 4/31 (12.9%) | 5 | 4/34 (11.8%) | 5 | 0/7 (0%) | 0 | 1/8 (12.5%) | 2 |
| Bronchitis | 14/31 (45.2%) | 66 | 15/34 (44.1%) | 66 | 0/7 (0%) | 0 | 6/8 (75%) | 19 |
| Chronic sinusitis | 0/31 (0%) | 0 | 2/34 (5.9%) | 3 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Enteritis infectious | 1/31 (3.2%) | 1 | 2/34 (5.9%) | 2 | 0/7 (0%) | 0 | 1/8 (12.5%) | 1 |
| Enterobiasis | 4/31 (12.9%) | 5 | 0/34 (0%) | 0 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Enterocolitis viral | 0/31 (0%) | 0 | 3/34 (8.8%) | 3 | 0/7 (0%) | 0 | 1/8 (12.5%) | 2 |
| Folliculitis | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/7 (0%) | 0 | 1/8 (12.5%) | 1 |
| Furuncle | 2/31 (6.5%) | 2 | 0/34 (0%) | 0 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Gastroenteritis | 10/31 (32.3%) | 18 | 14/34 (41.2%) | 25 | 0/7 (0%) | 0 | 1/8 (12.5%) | 2 |
| Gastroenteritis viral | 11/31 (35.5%) | 20 | 9/34 (26.5%) | 14 | 0/7 (0%) | 0 | 4/8 (50%) | 8 |
| Herpes simplex | 1/31 (3.2%) | 1 | 2/34 (5.9%) | 3 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Herpes zoster | 0/31 (0%) | 0 | 2/34 (5.9%) | 3 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Hordeolum | 2/31 (6.5%) | 2 | 1/34 (2.9%) | 1 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Impetigo | 6/31 (19.4%) | 9 | 9/34 (26.5%) | 9 | 2/7 (28.6%) | 5 | 1/8 (12.5%) | 2 |
| Infection | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/7 (0%) | 0 | 1/8 (12.5%) | 1 |
| Influenza | 16/31 (51.6%) | 30 | 25/34 (73.5%) | 39 | 6/7 (85.7%) | 7 | 4/8 (50%) | 7 |
| Lymphadenitis bacterial | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/7 (14.3%) | 1 | 0/8 (0%) | 0 |
| Molluscum contagiosum | 2/31 (6.5%) | 2 | 4/34 (11.8%) | 4 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Mumps | 5/31 (16.1%) | 5 | 6/34 (17.6%) | 6 | 1/7 (14.3%) | 1 | 1/8 (12.5%) | 1 |
| Nasopharyngitis | 19/31 (61.3%) | 66 | 27/34 (79.4%) | 212 | 6/7 (85.7%) | 38 | 5/8 (62.5%) | 20 |
| Otitis externa | 2/31 (6.5%) | 2 | 2/34 (5.9%) | 2 | 1/7 (14.3%) | 1 | 2/8 (25%) | 2 |
| Otitis media | 7/31 (22.6%) | 11 | 12/34 (35.3%) | 17 | 1/7 (14.3%) | 11 | 3/8 (37.5%) | 12 |
| Otitis media acute | 4/31 (12.9%) | 13 | 4/34 (11.8%) | 6 | 1/7 (14.3%) | 1 | 1/8 (12.5%) | 2 |
| Parotitis | 1/31 (3.2%) | 1 | 1/34 (2.9%) | 1 | 1/7 (14.3%) | 3 | 0/8 (0%) | 0 |
| Pharyngitis | 8/31 (25.8%) | 46 | 14/34 (41.2%) | 74 | 2/7 (28.6%) | 8 | 3/8 (37.5%) | 9 |
| Pneumonia mycoplasmal | 2/31 (6.5%) | 2 | 1/34 (2.9%) | 1 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Rhinitis | 5/31 (16.1%) | 9 | 6/34 (17.6%) | 9 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Sinusitis | 1/31 (3.2%) | 1 | 5/34 (14.7%) | 9 | 1/7 (14.3%) | 1 | 1/8 (12.5%) | 9 |
| Tonsillitis | 1/31 (3.2%) | 1 | 7/34 (20.6%) | 19 | 1/7 (14.3%) | 1 | 2/8 (25%) | 4 |
| Varicella | 6/31 (19.4%) | 6 | 4/34 (11.8%) | 4 | 0/7 (0%) | 0 | 1/8 (12.5%) | 1 |
| Injury, poisoning and procedural complications | ||||||||
| Arthropod sting | 1/31 (3.2%) | 2 | 2/34 (5.9%) | 2 | 2/7 (28.6%) | 2 | 0/8 (0%) | 0 |
| Chillblains | 1/31 (3.2%) | 1 | 2/34 (5.9%) | 2 | 1/7 (14.3%) | 2 | 0/8 (0%) | 0 |
| Contusion | 1/31 (3.2%) | 1 | 6/34 (17.6%) | 7 | 0/7 (0%) | 0 | 2/8 (25%) | 2 |
| Excoriation | 2/31 (6.5%) | 2 | 3/34 (8.8%) | 4 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Hand fracture | 0/31 (0%) | 0 | 2/34 (5.9%) | 2 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Joint sprain | 0/31 (0%) | 0 | 3/34 (8.8%) | 3 | 1/7 (14.3%) | 1 | 1/8 (12.5%) | 1 |
| Thermal burn | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/7 (0%) | 0 | 1/8 (12.5%) | 1 |
| Wound | 0/31 (0%) | 0 | 2/34 (5.9%) | 2 | 1/7 (14.3%) | 1 | 0/8 (0%) | 0 |
| Investigations | ||||||||
| Alanine aminotransferase increased | 1/31 (3.2%) | 1 | 1/34 (2.9%) | 1 | 1/7 (14.3%) | 2 | 1/8 (12.5%) | 1 |
| Antibody test positive | 0/31 (0%) | 0 | 2/34 (5.9%) | 2 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Aspartate aminotransferase increased | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/7 (14.3%) | 2 | 1/8 (12.5%) | 1 |
| Blood urine present | 0/31 (0%) | 0 | 2/34 (5.9%) | 2 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Neutrophil count decreased | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/7 (0%) | 0 | 1/8 (12.5%) | 1 |
| White blood cell count decreased | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/7 (0%) | 0 | 1/8 (12.5%) | 1 |
| White blood cell count increased | 1/31 (3.2%) | 3 | 2/34 (5.9%) | 2 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||
| Hyperinsulinaemia | 0/31 (0%) | 0 | 2/34 (5.9%) | 2 | 1/7 (14.3%) | 1 | 0/8 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthralgia | 1/31 (3.2%) | 3 | 6/34 (17.6%) | 10 | 1/7 (14.3%) | 1 | 0/8 (0%) | 0 |
| Dactylitis | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/7 (0%) | 0 | 1/8 (12.5%) | 1 |
| Pain in extremity | 3/31 (9.7%) | 3 | 3/34 (8.8%) | 7 | 1/7 (14.3%) | 1 | 1/8 (12.5%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Fibromatosis | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/7 (0%) | 0 | 1/8 (12.5%) | 1 |
| Skin papilloma | 4/31 (12.9%) | 4 | 3/34 (8.8%) | 4 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Nervous system disorders | ||||||||
| Convulsion | 2/31 (6.5%) | 4 | 0/34 (0%) | 0 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Febrile convulsion | 2/31 (6.5%) | 3 | 2/34 (5.9%) | 3 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Headache | 4/31 (12.9%) | 4 | 4/34 (11.8%) | 10 | 1/7 (14.3%) | 1 | 0/8 (0%) | 0 |
| Renal and urinary disorders | ||||||||
| Enuresis | 2/31 (6.5%) | 2 | 0/34 (0%) | 0 | 0/7 (0%) | 0 | 1/8 (12.5%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Asthma | 7/31 (22.6%) | 11 | 5/34 (14.7%) | 26 | 1/7 (14.3%) | 1 | 2/8 (25%) | 2 |
| Cough | 2/31 (6.5%) | 2 | 4/34 (11.8%) | 7 | 1/7 (14.3%) | 1 | 1/8 (12.5%) | 1 |
| Epistaxis | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/7 (0%) | 0 | 2/8 (25%) | 4 |
| Oropharyngeal pain | 2/31 (6.5%) | 2 | 0/34 (0%) | 0 | 0/7 (0%) | 0 | 1/8 (12.5%) | 1 |
| Rhinitis allergic | 8/31 (25.8%) | 10 | 8/34 (23.5%) | 21 | 1/7 (14.3%) | 1 | 5/8 (62.5%) | 6 |
| Rhinitis seasonal | 0/31 (0%) | 0 | 1/34 (2.9%) | 2 | 0/7 (0%) | 0 | 1/8 (12.5%) | 6 |
| Rhinorrhoea | 4/31 (12.9%) | 5 | 3/34 (8.8%) | 4 | 0/7 (0%) | 0 | 1/8 (12.5%) | 4 |
| Tonsillar disorder | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/7 (0%) | 0 | 1/8 (12.5%) | 1 |
| Tonsillar hypertrophy | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/7 (0%) | 0 | 1/8 (12.5%) | 1 |
| Upper respiratory tract inflammation | 22/31 (71%) | 147 | 22/34 (64.7%) | 94 | 5/7 (71.4%) | 14 | 6/8 (75%) | 32 |
| Skin and subcutaneous tissue disorders | ||||||||
| Acne | 0/31 (0%) | 0 | 3/34 (8.8%) | 4 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Dermatitis | 0/31 (0%) | 0 | 2/34 (5.9%) | 4 | 0/7 (0%) | 0 | 1/8 (12.5%) | 2 |
| Dermatitis atopic | 3/31 (9.7%) | 3 | 4/34 (11.8%) | 4 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Dermatitis contact | 1/31 (3.2%) | 1 | 2/34 (5.9%) | 2 | 1/7 (14.3%) | 1 | 1/8 (12.5%) | 1 |
| Dry skin | 2/31 (6.5%) | 2 | 2/34 (5.9%) | 2 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Eczema | 9/31 (29%) | 14 | 10/34 (29.4%) | 24 | 2/7 (28.6%) | 2 | 2/8 (25%) | 2 |
| Eczema asteatotic | 2/31 (6.5%) | 2 | 3/34 (8.8%) | 5 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Ingrowing nail | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 1/7 (14.3%) | 1 | 0/8 (0%) | 0 |
| Pruritus | 0/31 (0%) | 0 | 2/34 (5.9%) | 3 | 0/7 (0%) | 0 | 0/8 (0%) | 0 |
| Rash | 0/31 (0%) | 0 | 2/34 (5.9%) | 2 | 1/7 (14.3%) | 1 | 1/8 (12.5%) | 1 |
| Urticaria | 4/31 (12.9%) | 5 | 3/34 (8.8%) | 3 | 1/7 (14.3%) | 1 | 0/8 (0%) | 0 |
| Xeroderma | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/7 (0%) | 0 | 1/8 (12.5%) | 1 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Novo Nordisk acknowledges the Investigator's right to publish the entire results of the trial. Any such scientific paper, presentation, communication or other information concerning the investigation described in this protocol, must be submitted in writing to Novo Nordisk Trial Manager prior to submission for publication/presentation for comments. Comments will be given within four weeks from receipt of the manuscript.
Results Point of Contact
| Name/Title | Public Access to Clinical Trials |
|---|---|
| Organization | Novo Nordisk A/S |
| Phone | |
| clinicaltrials@novonordisk.com |
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00184717
Other Study ID Numbers:
- GHLIQUID-1517
- JapicCTI-050137
- JapicCTI-050132
- 2017-000914-47
- NCT00184704
First Posted:
Sep 16, 2005
Last Update Posted:
Jul 7, 2017
Last Verified:
Jun 1, 2017