TULIPIA: Study to Assess the Efficacy and Safety of Repeated Administration of BIM 23A760 in Patients With Acromegaly
Sponsor
Ipsen (Industry)
Overall Status
Terminated
CT.gov ID
NCT00994214
Collaborator
(none)
109
23
4
16
4.7
0.3
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the efficacy of repeated subcutaneous (under the skin) injections at different doses of BIM 23A760 on growth hormone and insulin-like growth factor-1 levels in patients with acromegaly after 6 months of treatment.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
109 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II, Open, Randomised, Parallel Group, Noncomparative Multicentre Study to Assess the Efficacy and Safety of Repeated Subcutaneous (S.C.) Administration of Different Doses of BIM 23A760 in Acromegalic Patients
Study Start Date
:
Oct 1, 2009
Actual Primary Completion Date
:
Feb 1, 2011
Actual Study Completion Date
:
Feb 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: BIM 23A760 1 mg
|
Drug: BIM 23A760
Subcutaneous injections of BIM23A760 once a week. Until progression or unacceptable toxicity develops.
|
| Experimental: BIM 23A760 2 mg
|
Drug: BIM 23A760
Subcutaneous injections of BIM23A760 once a week. Until progression or unacceptable toxicity develops.
|
| Experimental: BIM 23A760 4 mg
|
Drug: BIM 23A760
Subcutaneous injections of BIM23A760 once a week. Until progression or unacceptable toxicity develops.
|
| Experimental: BIM 23A760 6 mg
|
Drug: BIM 23A760
Subcutaneous injections of BIM23A760 once a week. Until progression or unacceptable toxicity develops.
|
Outcome Measures
Primary Outcome Measures
- Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 [At Month 6]
Secondary Outcome Measures
- Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 [At Month 3]
- Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 [At Month 1]
- Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6 [0-3 hr on Baseline (Day 1) and Months 1, 3 and 6]
Percentage change from Baseline at month X = (Mean GH at month X - Mean GH at baseline) x 100 / Mean GH at baseline
- Changes in IGF-1 [Baseline (Day 1) and Month 6]
- Percentage Change in Ring Finger Circumference [Baseline (Day 1) and Month 6]
Percentage change from Baseline at month X = (Ring finger circumference at month X - ring finger circumference at baseline) x 100 / ring finger circumference at baseline.
- Number of Subjects Reported Adverse Events During the Study [Up to Visit 10 (An average of 6.5 Months)]
For summaries of intensity and causality, individual patients may be reported in more than one category. In the event of multiple episodes of AEs being reported by the same patient during the study, the maximum intensity (severe > moderate > mild) and the most serious causality (related > not related) have been chosen. TEAE (Treatment emergent adverse event) are reported by Maximum Dose Received in Each Part of the Study.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
IGF-1 ≥1.3 x upper limit normal (ULN)
-
Nadir serum GH concentration ≥0.4 ng/mL in an oral glucose tolerance test (OGTT)
-
Patient must have documentation supporting the diagnosis of acromegaly, including elevated GH and/or insulin-like growth factor-1 (IGF-1) levels.
Exclusion Criteria:
-
The patient has received long acting somatostatin analogues within 6 months of study entry
-
The patient has undergone radiotherapy at any time prior to study entry
-
The time between pituitary surgery (if any) and study entry is less than 6 weeks
-
The patient suffers from macroadenoma with visual field defects due to chiasmatic compression
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pituitary Center | Los Angeles | California | United States | 90048 |
| 2 | Massachusetts General Hospital / Neuroendocrine Unit | Boston | Massachusetts | United States | 02114 |
| 3 | Oregon University, Dept. of Endocrinology and Neurosurgery | Portland | Oregon | United States | 97239 |
| 4 | UZ Leuven | Leuven | Belgium | 3000 | |
| 5 | Centre Hospitalier Universitaire de Liège | Liège | Belgium | B-4000 | |
| 6 | Hospital Universitário Clementino Fraga Filho | Rio de Janeiro | Brazil | 21941-913 | |
| 7 | Hospital das Clínicas de São Paulo | Sao Paulo | Brazil | 05403-0000 | |
| 8 | University Hospital Olomouc, Clinic of Internal Medicine | Olomouc | Czechia | 775 20 | |
| 9 | General University Hospital, Clinic of Internal Medicine, | Praha | Czechia | 128 08 | |
| 10 | Hôpital Bicêtre | Le Kremlin Bicêtre | France | 94275 Cedex | |
| 11 | Hôpital de la Timone | Marseille | France | 13385 Cedex 05 | |
| 12 | P. Stradins Clinical University Hospital | Riga | Latvia | LV 1002 | |
| 13 | Kaunas Medical University Hospital | Kaunas | Lithuania | LT-50009 | |
| 14 | Vilnius University Hospital "Santariskiu Klinikos" | Vilnius | Lithuania | LT-08661 | |
| 15 | UIM Endocrinología Experimental, Hospital de Especialidades | Mexico City | Mexico | DF | |
| 16 | Insituto Nacional de Neurologia y Neurocirugia | México City | Mexico | 14269 México | |
| 17 | Department of Endocrinology, Erasmus MC | Rotterdam | Netherlands | 3000 CA | |
| 18 | Voivodeship Specialistic Hospital No 3 | Rybnik | Poland | 44-200 | |
| 19 | "C.I. Parhon" National Institute of Endocrinology | Bucharest | Romania | 011863 | |
| 20 | Karolinska University Hospital | Stockholm | Sweden | 171 76 | |
| 21 | Academy of Medical Science of Ukraine, Department of Clinical Endocrinology | Kharkiv | Ukraine | 61002 | |
| 22 | Administration of Medical Services and Rehabilitation of "ARTEM" | Kyiv | Ukraine | 04050 | |
| 23 | National Medical University n.a. M.I.Pirogov | Vinnitsa | Ukraine | 21010 |
Sponsors and Collaborators
- Ipsen
Investigators
- Study Director: Ipsen Medical Director, Ipsen
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Ipsen
ClinicalTrials.gov Identifier:
NCT00994214
Other Study ID Numbers:
- 2-55-52060-003
- 2009-010787-42
First Posted:
Oct 14, 2009
Last Update Posted:
Nov 22, 2019
Last Verified:
Nov 1, 2019
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | This was a multicentre study conducted at 36 investigational sites in 16 countries: Czech Republic, Lithuania, Poland, Romania, Ukraine, Latvia, USA, United Kingdom (UK), Italy, Mexico, Brazil, France, Belgium, Netherlands, Germany and Sweden. |
|---|---|
| Pre-assignment Detail | Screened subjects were 109 and screen failures were 33. Subjects randomised and treated in part A were 76. Subjects completed part A were 21 and subjects entered Part B were 12, excluding 9 subjects, who chose not to continue in part B. No subjects completed the study. |
| Arm/Group Title | Arm A: BIM 23A760 1 mg | Arm B: BIM 23A760 2 mg | Arm C: BIM 23A760 4 mg | Arm D: BIM 23A760 6 mg |
|---|---|---|---|---|
| Arm/Group Description | BIM 23A760 1 mg subcutaneous 24 weekly injections. | BIM 23A760 2 mg subcutaneous 24 weekly injections. | BIM 23A760 4 mg subcutaneous 24 weekly injections. | BIM 23A760 6 mg subcutaneous 24 weekly injections. |
| Period Title: ITT (Intention-to-Treat) - Part A | ||||
| STARTED | 19 | 19 | 18 | 20 |
| COMPLETED | 5 | 6 | 5 | 5 |
| NOT COMPLETED | 14 | 13 | 13 | 15 |
| Period Title: ITT (Intention-to-Treat) - Part A | ||||
| STARTED | 4 | 3 | 2 | 3 |
| Received Maximum Dose of 1mg | 0 | 0 | 0 | 0 |
| Received Maximum Dose of 2mg | 3 | 0 | 0 | 0 |
| Received Maximum Dose of 4mg | 1 | 3 | 0 | 0 |
| Received Maximum Dose of 6mg | 0 | 0 | 2 | 3 |
| COMPLETED | 0 | 0 | 0 | 0 |
| NOT COMPLETED | 4 | 3 | 2 | 3 |
Baseline Characteristics
| Arm/Group Title | Arm A: BIM 23A760 1 mg | Arm B: BIM 23A760 2 mg | Arm C: BIM 23A760 4 mg | Arm D: BIM 23A760 6 mg | Total |
|---|---|---|---|---|---|
| Arm/Group Description | BIM 23A760 1 mg subcutaneous 24 weekly injections. | BIM 23A760 2 mg subcutaneous 24 weekly injections. | BIM 23A760 4 mg subcutaneous 24 weekly injections. | BIM 23A760 6 mg subcutaneous 24 weekly injections.. | Total of all reporting groups |
| Overall Participants | 19 | 19 | 18 | 20 | 76 |
| Age (Years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [Years] |
42.8
(11.3)
|
48.7
(11.2)
|
40.3
(11.3)
|
43.4
(12.9)
|
43.8
(11.9)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
10
52.6%
|
13
68.4%
|
6
33.3%
|
13
65%
|
42
55.3%
|
| Male |
9
47.4%
|
6
31.6%
|
12
66.7%
|
7
35%
|
34
44.7%
|
| Race/Ethnicity, Customized (Number) [Number] | |||||
| Caucasian/White |
17
89.5%
|
14
73.7%
|
13
72.2%
|
18
90%
|
62
81.6%
|
| Multiple race |
2
10.5%
|
5
26.3%
|
5
27.8%
|
2
10%
|
14
18.4%
|
| Region of Enrollment (Number) [Number] | |||||
| Belgium |
1
5.3%
|
1
5.3%
|
0
0%
|
0
0%
|
2
2.6%
|
| Brazil |
1
5.3%
|
1
5.3%
|
3
16.7%
|
5
25%
|
10
13.2%
|
| Czech Republic |
1
5.3%
|
1
5.3%
|
0
0%
|
1
5%
|
3
3.9%
|
| Lithuania |
1
5.3%
|
1
5.3%
|
3
16.7%
|
1
5%
|
6
7.9%
|
| Mexico |
2
10.5%
|
4
21.1%
|
4
22.2%
|
1
5%
|
11
14.5%
|
| Netherlands |
2
10.5%
|
0
0%
|
0
0%
|
1
5%
|
3
3.9%
|
| Poland |
1
5.3%
|
1
5.3%
|
0
0%
|
0
0%
|
2
2.6%
|
| Romania |
4
21.1%
|
3
15.8%
|
1
5.6%
|
4
20%
|
12
15.8%
|
| Ukraine |
6
31.6%
|
4
21.1%
|
4
22.2%
|
6
30%
|
20
26.3%
|
| France |
0
0%
|
1
5.3%
|
0
0%
|
1
5%
|
2
2.6%
|
| United States |
0
0%
|
2
10.5%
|
1
5.6%
|
0
0%
|
3
3.9%
|
| Latvia |
0
0%
|
0
0%
|
1
5.6%
|
0
0%
|
1
1.3%
|
| Sweden |
0
0%
|
0
0%
|
1
5.6%
|
0
0%
|
1
1.3%
|
| Height (cm) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [cm] |
170.1
(8.1)
|
170.3
(13.2)
|
175.0
(10.1)
|
166.4
(8.6)
|
170.3
(10.4)
|
| Diabetic status at entry (Number) [Number] | |||||
| Diabetic |
2
10.5%
|
1
5.3%
|
2
11.1%
|
2
10%
|
7
9.2%
|
| Non-diabetic |
17
89.5%
|
18
94.7%
|
16
88.9%
|
18
90%
|
69
90.8%
|
| Insulin-like growth factor 1 (IGF-1) (Percentage of ULN(Upper limit of number)) [Median (Full Range) ] | |||||
| Median (Full Range) [Percentage of ULN(Upper limit of number)] |
307
|
315
|
382
|
335
|
333
|
| Growth Hormone (GH) (ng/mL) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [ng/mL] |
16.79
(24.56)
|
20.99
(59.28)
|
28.60
(64.83)
|
26.59
(63.47)
|
23.21
(55.54)
|
| Baseline Prolactin (μg/L) [Mean (Standard Deviation) ] | |||||
| Males (n=A:9,B:6,C:12, D:7, and Total:34) |
11.506
(14.233)
|
34.113
(49.588)
|
41.657
(60.965)
|
83.036
(131.024)
|
40.86
(72.52)
|
| Pre-menopausal female(n=A:4,B:4,C:4,D:7,&Totl:19) |
19.838
(15.247)
|
26.158
(19.798)
|
35.608
(25.536)
|
23.634
(23.778)
|
25.88
(21.94)
|
| Post-menopausal female(n=A:6,B:9,C:2,D:6,&Totl:23) |
8.420
(3.167)
|
16.409
(24.232)
|
7.870
(0.693)
|
25.118
(39.986)
|
15.85
(25.89)
|
| Ring Finger Circumference (mm) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [mm] |
70.2
(5.6)
|
68.5
(6.2)
|
71.2
(4.7)
|
68.4
(6.3)
|
69.53
(5.75)
|
Outcome Measures
| Title | Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 |
|---|---|
| Description | |
| Time Frame | At Month 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intention-to-Treat (ITT) population: All randomized subjects who received at least one dose of study medication. N=Number of subjects attended Month 6 (visit 9). |
| Arm/Group Title | Arm A: BIM 23A760 1 mg | Arm B: BIM 23A760 2 mg | Arm C: BIM 23A760 4 mg | Arm D: BIM 23A760 6 mg |
|---|---|---|---|---|
| Arm/Group Description | BIM 23A760 1 mg subcutaneous 24 weekly injections. | BIM 23A760 2 mg subcutaneous 24 weekly injections. | BIM 23A760 4 mg subcutaneous 24 weekly injections. | BIM 23A760 6 mg subcutaneous 24 weekly injections. |
| Measure Participants | 6 | 7 | 5 | 5 |
| Mean GH ≤2.5 ng/mL and Normalised IGF-1: Yes |
0
|
0
|
0
|
0
|
| Mean GH ≤2.5 ng/mL and Normalised IGF-1: No |
83.3
|
100.0
|
100.0
|
100.0
|
| Missing |
16.7
|
0
|
0
|
0
|
| Title | Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 |
|---|---|
| Description | |
| Time Frame | At Month 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population. N=Number of subjects attended Month 3 (visit 7). |
| Arm/Group Title | Arm A: BIM 23A760 1 mg | Arm B: BIM 23A760 2 mg | Arm C: BIM 23A760 4 mg | Arm D: BIM 23A760 6 mg |
|---|---|---|---|---|
| Arm/Group Description | BIM 23A760 1 mg subcutaneous 24 weekly injections. | BIM 23A760 2 mg subcutaneous 24 weekly injections. | BIM 23A760 4 mg subcutaneous 24 weekly injections. | BIM 23A760 6 mg subcutaneous 24 weekly injections. |
| Measure Participants | 12 | 13 | 12 | 13 |
| Mean GH ≤2.5 ng/mL and Normalised IGF-1: Yes |
0
|
0
|
0
|
7.7
|
| Mean GH ≤2.5 ng/mL and Normalised IGF-1: No |
100
|
100
|
100
|
92.3
|
| Missing |
0
|
0
|
0
|
0
|
| Title | Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 |
|---|---|
| Description | |
| Time Frame | At Month 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population. N=Number of subjects attended Month 1 (visit 5). |
| Arm/Group Title | Arm A: BIM 23A760 1 mg | Arm B: BIM 23A760 2 mg | Arm C: BIM 23A760 4 mg | Arm D: BIM 23A760 6 mg |
|---|---|---|---|---|
| Arm/Group Description | BIM 23A760 1 mg subcutaneous 24 weekly injections. | BIM 23A760 2 mg subcutaneous 24 weekly injections. | BIM 23A760 4 mg subcutaneous 24 weekly injections | BIM 23A760 6 mg subcutaneous 24 weekly injections |
| Measure Participants | 19 | 18 | 18 | 20 |
| Mean GH ≤2.5 ng/mL and Normalised IGF-1: Yes |
5.3
|
0
|
0
|
5.0
|
| Mean GH ≤2.5 ng/mL and Normalised IGF-1: No |
94.7
|
100
|
100
|
95.0
|
| Missing |
0
|
0
|
0
|
0
|
| Title | Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6 |
|---|---|
| Description | Percentage change from Baseline at month X = (Mean GH at month X - Mean GH at baseline) x 100 / Mean GH at baseline |
| Time Frame | 0-3 hr on Baseline (Day 1) and Months 1, 3 and 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| N=Number of patients randomised to treatment in IGF-1 <2.5 x upper limit of normal (ULN) stratum and IGF-1 ≥2.5 x ULN stratum. |
| Arm/Group Title | Arm A: BIM 23A760 1 mg | Arm B: BIM 23A760 2 mg | Arm C: BIM 23A760 4 mg | Arm D: BIM 23A760 6 mg |
|---|---|---|---|---|
| Arm/Group Description | BIM 23A760 1 mg subcutaneous 24 weekly injections | BIM 23A760 2 mg subcutaneous 24 weekly injections | BIM 23A760 4 mg subcutaneous 24 weekly injections | BIM 23A760 6 mg subcutaneous 24 weekly injections. |
| Measure Participants | 15 | 15 | 15 | 16 |
| At Month 1: IGF-1<2.5 x ULN |
4.10
(53.03)
|
-0.55
(23.98)
|
-9.92
(71.51)
|
-17.59
(41.82)
|
| At Month 3: IGF-1<2.5 x ULN |
29.26
(45.97)
|
-18.99
(21.36)
|
17.48
(127.97)
|
-28.84
(43.25)
|
| At Month 6: IGF-1<2.5 x ULN |
71.44
(35.97)
|
3.32
(9.09)
|
82.45
(0)
|
-38.21
(27.27)
|
| At Month 1: IGF-1≥2.5 x UL |
-39.20
(30.33)
|
-22.24
(34.72)
|
-10.64
(51.18)
|
-23.63
(39.57)
|
| At Month 3: IGF-1≥2.5 x UL |
-26.14
(39.60)
|
-22.35
(31.71)
|
-7.64
(30.11)
|
-20.53
(42.23)
|
| At Month 6: IGF-1≥2.5 x UL |
-36.15
(45.63)
|
15.28
(82.56)
|
-10.43
(28.90)
|
-19.47
(68.90)
|
| Title | Changes in IGF-1 |
|---|---|
| Description | |
| Time Frame | Baseline (Day 1) and Month 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population |
| Arm/Group Title | Arm A: BIM 23A760 1 mg | Arm B: BIM 23A760 2 mg | Arm C: BIM 23A760 4 mg | Arm D: BIM 23A760 6 mg |
|---|---|---|---|---|
| Arm/Group Description | BIM 23A760 1 mg subcutaneous 24 weekly injections. | BIM 23A760 2 mg subcutaneous 24 weekly injections. | BIM 23A760 4 mg subcutaneous 24 weekly injections. | BIM 23A760 6 mg subcutaneous 24 weekly injections. |
| Measure Participants | 19 | 19 | 18 | 20 |
| Mean (Standard Deviation) [Percentage of ULN] |
-51.30
(136.66)
|
-53.31
(80.57)
|
-40.53
(56.65)
|
-85.91
(95.34)
|
| Title | Percentage Change in Ring Finger Circumference |
|---|---|
| Description | Percentage change from Baseline at month X = (Ring finger circumference at month X - ring finger circumference at baseline) x 100 / ring finger circumference at baseline. |
| Time Frame | Baseline (Day 1) and Month 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population. N=Number of subjects attended Month 6 (visit 9). |
| Arm/Group Title | Arm A: BIM 23A760 1 mg | Arm B: BIM 23A760 2 mg | Arm C: BIM 23A760 4 mg | Arm D: BIM 23A760 6 mg |
|---|---|---|---|---|
| Arm/Group Description | BIM 23A760 1 mg subcutaneous 24 weekly injections. | BIM 23A760 2 mg subcutaneous 24 weekly injections. | BIM 23A760 4 mg subcutaneous 24 weekly injections. | BIM 23A760 6 mg subcutaneous 24 weekly injections. |
| Measure Participants | 6 | 7 | 5 | 5 |
| Mean (Standard Deviation) [Percentage of Change in Ring Finger circ] |
-3.518
(3.688)
|
-1.469
(2.120)
|
-0.678
(2.409)
|
-4.003
(3.367)
|
| Title | Number of Subjects Reported Adverse Events During the Study |
|---|---|
| Description | For summaries of intensity and causality, individual patients may be reported in more than one category. In the event of multiple episodes of AEs being reported by the same patient during the study, the maximum intensity (severe > moderate > mild) and the most serious causality (related > not related) have been chosen. TEAE (Treatment emergent adverse event) are reported by Maximum Dose Received in Each Part of the Study. |
| Time Frame | Up to Visit 10 (An average of 6.5 Months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population Part B: Arm A: BIM 23A760 1 mg- 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received. |
| Arm/Group Title | Part A: Arm A: BIM 23A760 1 mg | Part A: Arm B: BIM 23A760 2 mg | Part A: Arm C: BIM 23A760 4 mg | Part A: Arm D: BIM 23A760 6 mg | Overall - Part A | Part B: Arm B: BIM 23A760 2 mg | Part B: Arm C: BIM 23A760 4 mg | Part B: Arm D: BIM 23A760 6 mg | Overall - Part B |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | |||||||||
| Measure Participants | 19 | 19 | 18 | 20 | 76 | 3 | 4 | 5 | 12 |
| Severe |
0
0%
|
1
5.3%
|
1
5.6%
|
2
10%
|
4
5.3%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| Moderate |
3
15.8%
|
8
42.1%
|
4
22.2%
|
7
35%
|
22
28.9%
|
0
NaN
|
0
NaN
|
3
NaN
|
3
NaN
|
| Mild |
11
57.9%
|
9
47.4%
|
12
66.7%
|
15
75%
|
47
61.8%
|
0
NaN
|
1
NaN
|
1
NaN
|
2
NaN
|
| Related |
7
36.8%
|
8
42.1%
|
10
55.6%
|
11
55%
|
36
47.4%
|
0
NaN
|
0
NaN
|
1
NaN
|
1
NaN
|
| Not Related |
8
42.1%
|
9
47.4%
|
6
33.3%
|
11
55%
|
34
44.7%
|
0
NaN
|
1
NaN
|
3
NaN
|
4
NaN
|
Adverse Events
| Time Frame | Up to Visit 10 (An average of 6.5 Months) | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received. | |||||||||||||||||
| Arm/Group Title | Part A: Arm A: BIM 23A760 1 mg | Part A: Arm B: BIM 23A760 2 mg | Part A: Arm C: BIM 23A760 4 mg | Part A: Arm D: BIM 23A760 6 mg | Overall - Part A | Part B: Arm B: BIM 23A760 2 mg | Part B: Arm C: BIM 23A760 4 mg | Part B: Arm D: BIM 23A760 6 mg | Overall - Part B | |||||||||
| Arm/Group Description | ||||||||||||||||||
All Cause Mortality |
||||||||||||||||||
| Part A: Arm A: BIM 23A760 1 mg | Part A: Arm B: BIM 23A760 2 mg | Part A: Arm C: BIM 23A760 4 mg | Part A: Arm D: BIM 23A760 6 mg | Overall - Part A | Part B: Arm B: BIM 23A760 2 mg | Part B: Arm C: BIM 23A760 4 mg | Part B: Arm D: BIM 23A760 6 mg | Overall - Part B | ||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||||||
Serious Adverse Events |
||||||||||||||||||
| Part A: Arm A: BIM 23A760 1 mg | Part A: Arm B: BIM 23A760 2 mg | Part A: Arm C: BIM 23A760 4 mg | Part A: Arm D: BIM 23A760 6 mg | Overall - Part A | Part B: Arm B: BIM 23A760 2 mg | Part B: Arm C: BIM 23A760 4 mg | Part B: Arm D: BIM 23A760 6 mg | Overall - Part B | ||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/19 (5.3%) | 2/19 (10.5%) | 0/18 (0%) | 0/20 (0%) | 3/76 (3.9%) | 0/3 (0%) | 0/4 (0%) | 2/5 (40%) | 2/12 (16.7%) | |||||||||
| Ear and labyrinth disorders | ||||||||||||||||||
| Vertigo | 0/19 (0%) | 0 | 1/19 (5.3%) | 1 | 0/18 (0%) | 0 | 0/20 (0%) | 0 | 1/76 (1.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| Gastrointestinal disorders | ||||||||||||||||||
| Nausea | 1/19 (5.3%) | 1 | 1/19 (5.3%) | 1 | 0/18 (0%) | 0 | 0/20 (0%) | 0 | 2/76 (2.6%) | 2 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| Gastritis | 0/19 (0%) | 0 | 0/19 (0%) | 0 | 0/18 (0%) | 0 | 0/20 (0%) | 0 | 0/76 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/5 (20%) | 1 | 1/12 (8.3%) | 1 |
| Infections and infestations | ||||||||||||||||||
| Sinusitis | 0/19 (0%) | 0 | 0/19 (0%) | 0 | 0/18 (0%) | 0 | 0/20 (0%) | 0 | 0/76 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/5 (20%) | 1 | 1/12 (8.3%) | 1 |
Other (Not Including Serious) Adverse Events |
||||||||||||||||||
| Part A: Arm A: BIM 23A760 1 mg | Part A: Arm B: BIM 23A760 2 mg | Part A: Arm C: BIM 23A760 4 mg | Part A: Arm D: BIM 23A760 6 mg | Overall - Part A | Part B: Arm B: BIM 23A760 2 mg | Part B: Arm C: BIM 23A760 4 mg | Part B: Arm D: BIM 23A760 6 mg | Overall - Part B | ||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 11/19 (57.9%) | 12/19 (63.2%) | 12/18 (66.7%) | 15/20 (75%) | 50/76 (65.8%) | 0/3 (0%) | 1/4 (25%) | 4/5 (80%) | 5/12 (41.7%) | |||||||||
| Blood and lymphatic system disorders | ||||||||||||||||||
| ANAEMIA | 1/19 (5.3%) | 1 | 0/19 (0%) | 0 | 0/18 (0%) | 0 | 2/20 (10%) | 2 | 3/76 (3.9%) | 3 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| PANCYTOPENIA | 0/19 (0%) | 0 | 1/19 (5.3%) | 1 | 0/18 (0%) | 0 | 0/20 (0%) | 0 | 1/76 (1.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| Ear and labyrinth disorders | ||||||||||||||||||
| VERTIGO | 0/19 (0%) | 0 | 1/19 (5.3%) | 1 | 0/18 (0%) | 0 | 0/20 (0%) | 0 | 1/76 (1.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| Endocrine disorders | ||||||||||||||||||
| HYPOTHYROIDISM | 0/19 (0%) | 0 | 0/19 (0%) | 0 | 0/18 (0%) | 0 | 1/20 (5%) | 1 | 1/76 (1.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| Eye disorders | ||||||||||||||||||
| EYE IRRITATION | 0/19 (0%) | 0 | 0/19 (0%) | 0 | 1/18 (5.6%) | 1 | 0/20 (0%) | 0 | 1/76 (1.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| LACRIMATION INCREASED | 0/19 (0%) | 0 | 0/19 (0%) | 0 | 1/18 (5.6%) | 1 | 0/20 (0%) | 0 | 1/76 (1.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| Gastrointestinal disorders | ||||||||||||||||||
| ABDOMINAL PAIN | 1/19 (5.3%) | 1 | 1/19 (5.3%) | 2 | 1/18 (5.6%) | 1 | 3/20 (15%) | 5 | 6/76 (7.9%) | 9 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| ABDOMINAL PAIN UPPER | 0/19 (0%) | 0 | 0/19 (0%) | 0 | 1/18 (5.6%) | 1 | 0/20 (0%) | 0 | 1/76 (1.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| CONSTIPATION | 0/19 (0%) | 0 | 1/19 (5.3%) | 1 | 1/18 (5.6%) | 1 | 2/20 (10%) | 2 | 4/76 (5.3%) | 4 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| DIARRHOEA | 2/19 (10.5%) | 3 | 1/19 (5.3%) | 1 | 1/18 (5.6%) | 10 | 2/20 (10%) | 7 | 6/76 (7.9%) | 21 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| FLATULENCE | 1/19 (5.3%) | 1 | 1/19 (5.3%) | 1 | 2/18 (11.1%) | 2 | 1/20 (5%) | 1 | 5/76 (6.6%) | 5 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| GASTROINTESTINAL PAIN | 1/19 (5.3%) | 1 | 0/19 (0%) | 0 | 0/18 (0%) | 0 | 0/20 (0%) | 0 | 1/76 (1.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| NAUSEA | 2/19 (10.5%) | 2 | 2/19 (10.5%) | 3 | 2/18 (11.1%) | 3 | 2/20 (10%) | 5 | 8/76 (10.5%) | 13 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| PROCTALGIA | 0/19 (0%) | 0 | 1/19 (5.3%) | 1 | 0/18 (0%) | 0 | 0/20 (0%) | 0 | 1/76 (1.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| VOMITING | 0/19 (0%) | 0 | 1/19 (5.3%) | 1 | 1/18 (5.6%) | 1 | 1/20 (5%) | 1 | 3/76 (3.9%) | 3 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| GASTRITIS | 0/19 (0%) | 0 | 0/19 (0%) | 0 | 0/18 (0%) | 0 | 0/20 (0%) | 0 | 0/76 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/5 (20%) | 1 | 1/12 (8.3%) | 1 |
| General disorders | ||||||||||||||||||
| ADMINISTRATION SITE REACTION | 0/19 (0%) | 0 | 0/19 (0%) | 0 | 0/18 (0%) | 0 | 1/20 (5%) | 7 | 1/76 (1.3%) | 7 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| APPLICATION SITE ERYTHEMA | 0/19 (0%) | 0 | 1/19 (5.3%) | 1 | 0/18 (0%) | 0 | 0/20 (0%) | 0 | 1/76 (1.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| APPLICATION SITE INDURATION | 0/19 (0%) | 0 | 0/19 (0%) | 0 | 1/18 (5.6%) | 1 | 1/20 (5%) | 1 | 2/76 (2.6%) | 2 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| ASTHENIA | 0/19 (0%) | 0 | 0/19 (0%) | 0 | 1/18 (5.6%) | 1 | 1/20 (5%) | 1 | 2/76 (2.6%) | 2 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| FATIGUE | 0/19 (0%) | 0 | 0/19 (0%) | 0 | 0/18 (0%) | 0 | 1/20 (5%) | 1 | 1/76 (1.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| HYPERTHERMIA | 0/19 (0%) | 0 | 0/19 (0%) | 0 | 1/18 (5.6%) | 1 | 0/20 (0%) | 0 | 1/76 (1.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| INJECTION SITE ERYTHEMA | 0/19 (0%) | 0 | 2/19 (10.5%) | 4 | 1/18 (5.6%) | 15 | 3/20 (15%) | 10 | 6/76 (7.9%) | 29 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| INJECTION SITE INDURATION | 2/19 (10.5%) | 2 | 2/19 (10.5%) | 4 | 4/18 (22.2%) | 5 | 1/20 (5%) | 2 | 9/76 (11.8%) | 13 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| INJECTION SITE INFLAMMATION | 1/19 (5.3%) | 1 | 0/19 (0%) | 0 | 0/18 (0%) | 0 | 0/20 (0%) | 0 | 1/76 (1.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| INJECTION SITE NODULE | 1/19 (5.3%) | 1 | 1/19 (5.3%) | 1 | 2/18 (11.1%) | 4 | 2/20 (10%) | 6 | 6/76 (7.9%) | 12 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| INJECTION SITE PAIN | 0/19 (0%) | 0 | 0/19 (0%) | 0 | 2/18 (11.1%) | 6 | 2/20 (10%) | 5 | 4/76 (5.3%) | 11 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| INJECTION SITE PRURITUS | 0/19 (0%) | 0 | 2/19 (10.5%) | 4 | 3/18 (16.7%) | 16 | 3/20 (15%) | 7 | 8/76 (10.5%) | 27 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| INJECTION SITE RASH | 1/19 (5.3%) | 1 | 0/19 (0%) | 0 | 0/18 (0%) | 0 | 0/20 (0%) | 0 | 1/76 (1.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| INJECTION SITE REACTION | 0/19 (0%) | 0 | 2/19 (10.5%) | 4 | 0/18 (0%) | 0 | 2/20 (10%) | 9 | 4/76 (5.3%) | 13 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| INJECTION SITE SWELLING | 0/19 (0%) | 0 | 1/19 (5.3%) | 2 | 0/18 (0%) | 0 | 0/20 (0%) | 0 | 1/76 (1.3%) | 2 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| OEDEMA PERIPHERAL | 0/19 (0%) | 0 | 0/19 (0%) | 0 | 0/18 (0%) | 0 | 1/20 (5%) | 1 | 1/76 (1.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| Hepatobiliary disorders | ||||||||||||||||||
| CHOLELITHIASIS | 0/19 (0%) | 0 | 0/19 (0%) | 0 | 0/18 (0%) | 0 | 0/20 (0%) | 0 | 0/76 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/5 (20%) | 1 | 1/12 (8.3%) | 1 |
| CYTOLYTIC HEPATITIS | 0/19 (0%) | 0 | 0/19 (0%) | 0 | 0/18 (0%) | 0 | 0/20 (0%) | 0 | 0/76 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 |
| Infections and infestations | ||||||||||||||||||
| CYSTITIS | 0/19 (0%) | 0 | 1/19 (5.3%) | 1 | 0/18 (0%) | 0 | 0/20 (0%) | 0 | 1/76 (1.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| FUNGAL SKIN INFECTION | 0/19 (0%) | 0 | 0/19 (0%) | 0 | 0/18 (0%) | 0 | 1/20 (5%) | 1 | 1/76 (1.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| NASOPHARYNGITIS | 1/19 (5.3%) | 1 | 1/19 (5.3%) | 1 | 0/18 (0%) | 0 | 1/20 (5%) | 1 | 3/76 (3.9%) | 3 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| SINUSITIS | 1/19 (5.3%) | 1 | 0/19 (0%) | 0 | 0/18 (0%) | 0 | 1/20 (5%) | 1 | 2/76 (2.6%) | 2 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/5 (20%) | 1 | 1/12 (8.3%) | 1 |
| URINARY TRACT INFECTION | 0/19 (0%) | 0 | 0/19 (0%) | 0 | 0/18 (0%) | 0 | 1/20 (5%) | 1 | 1/76 (1.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||||||||||||
| CONCUSSION | 0/19 (0%) | 0 | 1/19 (5.3%) | 1 | 0/18 (0%) | 0 | 0/20 (0%) | 0 | 1/76 (1.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| WOUND | 0/19 (0%) | 0 | 1/19 (5.3%) | 2 | 0/18 (0%) | 0 | 0/20 (0%) | 0 | 1/76 (1.3%) | 2 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| Investigations | ||||||||||||||||||
| ALANINE AMINOTRANSFERASE INCREASED | 0/19 (0%) | 0 | 2/19 (10.5%) | 2 | 0/18 (0%) | 0 | 0/20 (0%) | 0 | 2/76 (2.6%) | 2 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| ASPARTATE AMINOTRANSFERASE INCREASED | 0/19 (0%) | 0 | 2/19 (10.5%) | 2 | 0/18 (0%) | 0 | 0/20 (0%) | 0 | 2/76 (2.6%) | 2 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| BLOOD AMYLASE INCREASED | 0/19 (0%) | 0 | 1/19 (5.3%) | 1 | 0/18 (0%) | 0 | 0/20 (0%) | 0 | 1/76 (1.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| BLOOD GLUCOSE INCREASED | 0/19 (0%) | 0 | 0/19 (0%) | 0 | 1/18 (5.6%) | 1 | 0/20 (0%) | 0 | 1/76 (1.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| BLOOD PRESSURE DECREASED | 0/19 (0%) | 0 | 0/19 (0%) | 0 | 2/18 (11.1%) | 3 | 0/20 (0%) | 0 | 2/76 (2.6%) | 3 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| BLOOD PRESSURE DIASTOLIC INCREASED | 0/19 (0%) | 0 | 1/19 (5.3%) | 1 | 0/18 (0%) | 0 | 0/20 (0%) | 0 | 1/76 (1.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| BLOOD THYROID STIMULATING HORMONE DECREASED | 1/19 (5.3%) | 1 | 0/19 (0%) | 0 | 0/18 (0%) | 0 | 1/20 (5%) | 1 | 2/76 (2.6%) | 2 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| RED BLOOD CELLS URINE POSITIVE | 0/19 (0%) | 0 | 0/19 (0%) | 0 | 0/18 (0%) | 0 | 1/20 (5%) | 1 | 1/76 (1.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| TRI-IODOTHYRONINE FREE INCREASED | 1/19 (5.3%) | 1 | 0/19 (0%) | 0 | 0/18 (0%) | 0 | 0/20 (0%) | 0 | 1/76 (1.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| WHITE BLOOD CELL COUNT DECREASED | 0/19 (0%) | 0 | 1/19 (5.3%) | 1 | 0/18 (0%) | 0 | 0/20 (0%) | 0 | 1/76 (1.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| WHITE BLOOD CELLS URINE POSITIVE | 0/19 (0%) | 0 | 0/19 (0%) | 0 | 0/18 (0%) | 0 | 1/20 (5%) | 1 | 1/76 (1.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| BLOOD PRESSURE INCREASED | 0/19 (0%) | 0 | 0/19 (0%) | 0 | 0/18 (0%) | 0 | 0/20 (0%) | 0 | 0/76 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/5 (20%) | 1 | 1/12 (8.3%) | 1 |
| Metabolism and nutrition disorders | ||||||||||||||||||
| HYPERCHOLESTEROLAEMIA | 0/19 (0%) | 0 | 0/19 (0%) | 0 | 0/18 (0%) | 0 | 1/20 (5%) | 1 | 1/76 (1.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| HYPERGLYCAEMIA | 1/19 (5.3%) | 1 | 0/19 (0%) | 0 | 0/18 (0%) | 0 | 0/20 (0%) | 0 | 1/76 (1.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| IMPAIRED FASTING GLUCOSE | 0/19 (0%) | 0 | 1/19 (5.3%) | 1 | 0/18 (0%) | 0 | 1/20 (5%) | 2 | 2/76 (2.6%) | 3 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||||||||||||
| ARTHRALGIA | 0/19 (0%) | 0 | 1/19 (5.3%) | 1 | 0/18 (0%) | 0 | 1/20 (5%) | 1 | 2/76 (2.6%) | 2 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| BACK PAIN | 0/19 (0%) | 0 | 0/19 (0%) | 0 | 0/18 (0%) | 0 | 1/20 (5%) | 1 | 1/76 (1.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| MUSCULOSKELETAL CHEST PAIN | 1/19 (5.3%) | 1 | 0/19 (0%) | 0 | 0/18 (0%) | 0 | 0/20 (0%) | 0 | 1/76 (1.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| MYALGIA | 0/19 (0%) | 0 | 0/19 (0%) | 0 | 1/18 (5.6%) | 1 | 0/20 (0%) | 0 | 1/76 (1.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| PAIN IN EXTREMITY | 0/19 (0%) | 0 | 0/19 (0%) | 0 | 1/18 (5.6%) | 1 | 0/20 (0%) | 0 | 1/76 (1.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| RHEUMATOID ARTHRITIS | 0/19 (0%) | 0 | 1/19 (5.3%) | 1 | 0/18 (0%) | 0 | 0/20 (0%) | 0 | 1/76 (1.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| SYNOVITIS | 0/19 (0%) | 0 | 1/19 (5.3%) | 1 | 0/18 (0%) | 0 | 0/20 (0%) | 0 | 1/76 (1.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| Nervous system disorders | ||||||||||||||||||
| ACOUSTIC NEURITIS | 0/19 (0%) | 0 | 1/19 (5.3%) | 1 | 0/18 (0%) | 0 | 0/20 (0%) | 0 | 1/76 (1.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| CARPAL TUNNEL SYNDROME | 0/19 (0%) | 0 | 1/19 (5.3%) | 1 | 0/18 (0%) | 0 | 0/20 (0%) | 0 | 1/76 (1.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| DIZZINESS | 2/19 (10.5%) | 2 | 1/19 (5.3%) | 1 | 1/18 (5.6%) | 1 | 1/20 (5%) | 2 | 5/76 (6.6%) | 6 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| HEADACHE | 0/19 (0%) | 0 | 0/19 (0%) | 0 | 1/18 (5.6%) | 2 | 3/20 (15%) | 4 | 4/76 (5.3%) | 6 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| HYPOAESTHESIA | 0/19 (0%) | 0 | 1/19 (5.3%) | 1 | 0/18 (0%) | 0 | 0/20 (0%) | 0 | 1/76 (1.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| PARAESTHESIA | 1/19 (5.3%) | 1 | 0/19 (0%) | 0 | 0/18 (0%) | 0 | 0/20 (0%) | 0 | 1/76 (1.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| PRESYNCOPE | 0/19 (0%) | 0 | 1/19 (5.3%) | 1 | 0/18 (0%) | 0 | 0/20 (0%) | 0 | 1/76 (1.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| SYNCOPE | 0/19 (0%) | 0 | 0/19 (0%) | 0 | 1/18 (5.6%) | 1 | 0/20 (0%) | 0 | 1/76 (1.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| TRIGEMINAL NEURALGIA | 1/19 (5.3%) | 1 | 0/19 (0%) | 0 | 0/18 (0%) | 0 | 0/20 (0%) | 0 | 1/76 (1.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| Psychiatric disorders | ||||||||||||||||||
| INSOMNIA | 0/19 (0%) | 0 | 0/19 (0%) | 0 | 0/18 (0%) | 0 | 1/20 (5%) | 1 | 1/76 (1.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| Renal and urinary disorders | ||||||||||||||||||
| POLLAKIURIA | 0/19 (0%) | 0 | 0/19 (0%) | 0 | 1/18 (5.6%) | 1 | 0/20 (0%) | 0 | 1/76 (1.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| Reproductive system and breast disorders | ||||||||||||||||||
| MENSTRUATION DELAYED | 1/19 (5.3%) | 1 | 0/19 (0%) | 0 | 0/18 (0%) | 0 | 0/20 (0%) | 0 | 1/76 (1.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||
| OROPHARYNGEAL PAIN | 1/19 (5.3%) | 1 | 0/19 (0%) | 0 | 0/18 (0%) | 0 | 0/20 (0%) | 0 | 1/76 (1.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| RESPIRATORY DISORDER | 0/19 (0%) | 0 | 0/19 (0%) | 0 | 0/18 (0%) | 0 | 1/20 (5%) | 1 | 1/76 (1.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||||||||||||
| ERYTHEMA | 0/19 (0%) | 0 | 0/19 (0%) | 0 | 1/18 (5.6%) | 2 | 0/20 (0%) | 0 | 1/76 (1.3%) | 2 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| HYPERHIDROSIS | 0/19 (0%) | 0 | 1/19 (5.3%) | 1 | 0/18 (0%) | 0 | 1/20 (5%) | 2 | 2/76 (2.6%) | 3 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| HYPERKERATOSIS | 1/19 (5.3%) | 1 | 0/19 (0%) | 0 | 0/18 (0%) | 0 | 0/20 (0%) | 0 | 1/76 (1.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| PRURITUS | 1/19 (5.3%) | 2 | 0/19 (0%) | 0 | 0/18 (0%) | 0 | 1/20 (5%) | 1 | 2/76 (2.6%) | 3 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| Vascular disorders | ||||||||||||||||||
| HYPOTENSION | 0/19 (0%) | 0 | 1/19 (5.3%) | 1 | 3/18 (16.7%) | 4 | 0/20 (0%) | 0 | 4/76 (5.3%) | 5 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| ORTHOSTATIC HYPOTENSION | 0/19 (0%) | 0 | 0/19 (0%) | 0 | 1/18 (5.6%) | 1 | 0/20 (0%) | 0 | 1/76 (1.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| PERIPHERAL COLDNESS | 1/19 (5.3%) | 1 | 0/19 (0%) | 0 | 0/18 (0%) | 0 | 0/20 (0%) | 0 | 1/76 (1.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
| PHLEBITIS | 0/19 (0%) | 0 | 0/19 (0%) | 0 | 1/18 (5.6%) | 1 | 0/20 (0%) | 0 | 1/76 (1.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 |
Limitations/Caveats
The study was terminated prematurely due to lack of efficacy.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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 | Medical Director, Endocrinology |
|---|---|
| Organization | Ipsen |
| Phone | clinical.trials@ipsen.com |
| clinical.trials@ipsen.com |
Responsible Party:
Ipsen
ClinicalTrials.gov Identifier:
NCT00994214
Other Study ID Numbers:
- 2-55-52060-003
- 2009-010787-42
First Posted:
Oct 14, 2009
Last Update Posted:
Nov 22, 2019
Last Verified:
Nov 1, 2019