Study to Assess the Efficacy and Safety of Repeated Admin... | NCT00994214 | Trialant
NCT00994214
Sponsor
Ipsen
Status
Terminated
Last Update Posted
Nov 22, 2019Actual
Enrollment
109Actual
Phase
Phase 2
Conditions
Acromegaly
Interventions
BIM 23A760
Countries
United States
Belgium
Brazil
Czechia
France
Latvia
Lithuania
Mexico
Netherlands
Poland
Romania
Sweden
Ukraine
Protocol Section
Identification Module
NCT ID
NCT00994214
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
2-55-52060-003
Secondary IDs
ID
Type
Description
Link
2009-010787-42
EudraCT Number
Brief Title
Study to Assess the Efficacy and Safety of Repeated Administration of BIM 23A760 in Patients With Acromegaly
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
Acronym
TULIPIA
Organization
IpsenINDUSTRY
Status Module
Record Verification Date
Nov 2019
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Preliminary data from this study does not support expected inhibition of GH and IGF-1
Expanded Access Info
No
Start Date
Oct 2009
Primary Completion Date
Feb 2011Actual
Completion Date
Feb 2011Actual
First Submitted Date
Oct 13, 2009
First Submission Date that Met QC Criteria
Oct 13, 2009
First Posted Date
Oct 14, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 14, 2015
Results First Submitted that Met QC Criteria
Jan 7, 2016
Results First Posted Date
Feb 10, 2016Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Nov 21, 2019
Last Update Posted Date
Nov 22, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
IpsenINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
Detailed Description
Not provided
Conditions Module
Conditions
Acromegaly
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
109Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
BIM 23A760 1 mg
Experimental
Drug: BIM 23A760
BIM 23A760 2 mg
Experimental
Drug: BIM 23A760
BIM 23A760 4 mg
Experimental
Drug: BIM 23A760
BIM 23A760 6 mg
Experimental
Drug: BIM 23A760
Interventions
Name
Type
Description
Arm Group Labels
Other Names
BIM 23A760
Drug
Subcutaneous injections of BIM23A760 once a week. Until progression or unacceptable toxicity develops.
BIM 23A760 1 mg
BIM 23A760 2 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1
At Month 6
Secondary Outcomes
Measure
Description
Time Frame
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
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
75 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Ipsen Medical Director
Ipsen
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Pituitary Center
Los Angeles
California
90048
United States
Massachusetts General Hospital / Neuroendocrine Unit
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
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.
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.
Percent Change From Baseline in the Mean GH From 0-3 Hours at 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
0-3 hr on Baseline (Day 1) and Months 1, 3 and 6
Changes in IGF-1
Baseline (Day 1) and Month 6
Percentage Change in Ring Finger Circumference
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.
Baseline (Day 1) and Month 6
Number of Subjects Reported Adverse Events During the Study
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.
Up to Visit 10 (An average of 6.5 Months)
Boston
Massachusetts
02114
United States
Oregon University, Dept. of Endocrinology and Neurosurgery
Portland
Oregon
97239
United States
UZ Leuven
Leuven
3000
Belgium
Centre Hospitalier Universitaire de Liège
Liège
B-4000
Belgium
Hospital Universitário Clementino Fraga Filho
Rio de Janeiro
21941-913
Brazil
Hospital das Clínicas de São Paulo
São Paulo
05403-0000
Brazil
University Hospital Olomouc, Clinic of Internal Medicine
Olomouc
775 20
Czechia
General University Hospital, Clinic of Internal Medicine,
Prague
128 08
Czechia
Hôpital Bicêtre
Le Kremlin-Bicêtre
94275 Cedex
France
Hôpital de la Timone
Marseille
13385 Cedex 05
France
P. Stradins Clinical University Hospital
Riga
LV 1002
Latvia
Kaunas Medical University Hospital
Kaunas
LT-50009
Lithuania
Vilnius University Hospital "Santariskiu Klinikos"
Vilnius
LT-08661
Lithuania
UIM Endocrinología Experimental, Hospital de Especialidades
Mexico City
DF
Mexico
Insituto Nacional de Neurologia y Neurocirugia
México
14269 México
Mexico
Department of Endocrinology, Erasmus MC
Rotterdam
3000 CA
Netherlands
Voivodeship Specialistic Hospital No 3
Rybnik
44-200
Poland
"C.I. Parhon" National Institute of Endocrinology
Bucharest
011863
Romania
Karolinska University Hospital
Stockholm
171 76
Sweden
Academy of Medical Science of Ukraine, Department of Clinical Endocrinology
Kharkiv
61002
Ukraine
Administration of Medical Services and Rehabilitation of "ARTEM"
Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1
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).
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.
ITT population. N=Number of subjects attended Month 6 (visit 9).
Number of Subjects Reported Adverse Events During the Study
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.
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.
Posted
Number
Participants
Up to Visit 10 (An average of 6.5 Months)
ID
Title
Description
OG000
Part A: Arm A: BIM 23A760 1 mg
OG001
Part A: Arm B: BIM 23A760 2 mg
OG002
Part A: Arm C: BIM 23A760 4 mg
OG003
Part A: Arm D: BIM 23A760 6 mg
OG004
Overall - Part A
Time Frame
Up to Visit 10 (An average of 6.5 Months)
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.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part A: Arm A: BIM 23A760 1 mg
1
19
11
19
EG001
Part A: Arm B: BIM 23A760 2 mg
2
19
12
19
EG002
Part A: Arm C: BIM 23A760 4 mg
0
18
12
18
EG003
Part A: Arm D: BIM 23A760 6 mg
0
20
15
20
EG004
Overall - Part A
3
76
50
76
EG005
Part B: Arm B: BIM 23A760 2 mg
0
3
0
3
EG006
Part B: Arm C: BIM 23A760 4 mg
0
4
1
4
EG007
Part B: Arm D: BIM 23A760 6 mg
2
5
4
5
EG008
Overall - Part B
2
12
5
12
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Vertigo
Ear and labyrinth disorders
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected18 at risk
EG0030 events0 affected20 at risk
EG0041 events1 affected76 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected12 at risk
Nausea
Gastrointestinal disorders
MedDRA13.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected18 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected18 at risk
EG003
Sinusitis
Infections and infestations
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected18 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA13.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected18 at risk
EG0032 events2 affected20 at risk
EG0043 events3 affected76 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected12 at risk
PANCYTOPENIA
Blood and lymphatic system disorders
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected18 at risk
EG003
VERTIGO
Ear and labyrinth disorders
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected18 at risk
EG003
HYPOTHYROIDISM
Endocrine disorders
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected18 at risk
EG003
EYE IRRITATION
Eye disorders
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected18 at risk
EG003
LACRIMATION INCREASED
Eye disorders
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected18 at risk
EG003
ABDOMINAL PAIN
Gastrointestinal disorders
MedDRA13.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0012 events1 affected19 at risk
EG0021 events1 affected18 at risk
EG003
ABDOMINAL PAIN UPPER
Gastrointestinal disorders
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected18 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected19 at risk
EG0021 events1 affected18 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA13.1
Systematic Assessment
EG0003 events2 affected19 at risk
EG0011 events1 affected19 at risk
EG00210 events1 affected18 at risk
EG003
FLATULENCE
Gastrointestinal disorders
MedDRA13.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0011 events1 affected19 at risk
EG0022 events2 affected18 at risk
EG003
GASTROINTESTINAL PAIN
Gastrointestinal disorders
MedDRA13.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected18 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA13.1
Systematic Assessment
EG0002 events2 affected19 at risk
EG0013 events2 affected19 at risk
EG0023 events2 affected18 at risk
EG003
PROCTALGIA
Gastrointestinal disorders
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected18 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected19 at risk
EG0021 events1 affected18 at risk
EG003
ADMINISTRATION SITE REACTION
General disorders
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected18 at risk
EG003
APPLICATION SITE ERYTHEMA
General disorders
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected18 at risk
EG003
APPLICATION SITE INDURATION
General disorders
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected18 at risk
EG003
ASTHENIA
General disorders
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected18 at risk
EG003
FATIGUE
General disorders
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected18 at risk
EG003
HYPERTHERMIA
General disorders
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected18 at risk
EG003
INJECTION SITE ERYTHEMA
General disorders
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0014 events2 affected19 at risk
EG00215 events1 affected18 at risk
EG003
INJECTION SITE INDURATION
General disorders
MedDRA13.1
Systematic Assessment
EG0002 events2 affected19 at risk
EG0014 events2 affected19 at risk
EG0025 events4 affected18 at risk
EG003
INJECTION SITE INFLAMMATION
General disorders
MedDRA13.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected18 at risk
EG003
INJECTION SITE NODULE
General disorders
MedDRA13.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0011 events1 affected19 at risk
EG0024 events2 affected18 at risk
EG003
INJECTION SITE PAIN
General disorders
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected19 at risk
EG0026 events2 affected18 at risk
EG003
INJECTION SITE PRURITUS
General disorders
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0014 events2 affected19 at risk
EG00216 events3 affected18 at risk
EG003
INJECTION SITE RASH
General disorders
MedDRA13.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected18 at risk
EG003
INJECTION SITE REACTION
General disorders
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0014 events2 affected19 at risk
EG0020 events0 affected18 at risk
EG003
INJECTION SITE SWELLING
General disorders
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0012 events1 affected19 at risk
EG0020 events0 affected18 at risk
EG003
OEDEMA PERIPHERAL
General disorders
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected18 at risk
EG003
CYSTITIS
Infections and infestations
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected18 at risk
EG003
FUNGAL SKIN INFECTION
Infections and infestations
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected18 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA13.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected18 at risk
EG003
SINUSITIS
Infections and infestations
MedDRA13.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected18 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected18 at risk
EG003
CONCUSSION
Injury, poisoning and procedural complications
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected18 at risk
EG003
WOUND
Injury, poisoning and procedural complications
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0012 events1 affected19 at risk
EG0020 events0 affected18 at risk
EG003
ALANINE AMINOTRANSFERASE INCREASED
Investigations
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0012 events2 affected19 at risk
EG0020 events0 affected18 at risk
EG003
ASPARTATE AMINOTRANSFERASE INCREASED
Investigations
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0012 events2 affected19 at risk
EG0020 events0 affected18 at risk
EG003
BLOOD AMYLASE INCREASED
Investigations
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected18 at risk
EG003
BLOOD GLUCOSE INCREASED
Investigations
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected18 at risk
EG003
BLOOD PRESSURE DECREASED
Investigations
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected19 at risk
EG0023 events2 affected18 at risk
EG003
BLOOD PRESSURE DIASTOLIC INCREASED
Investigations
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected18 at risk
EG003
BLOOD THYROID STIMULATING HORMONE DECREASED
Investigations
MedDRA13.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected18 at risk
EG003
RED BLOOD CELLS URINE POSITIVE
Investigations
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected18 at risk
EG003
TRI-IODOTHYRONINE FREE INCREASED
Investigations
MedDRA13.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected18 at risk
EG003
WHITE BLOOD CELL COUNT DECREASED
Investigations
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected18 at risk
EG003
WHITE BLOOD CELLS URINE POSITIVE
Investigations
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected18 at risk
EG003
HYPERCHOLESTEROLAEMIA
Metabolism and nutrition disorders
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected18 at risk
EG003
HYPERGLYCAEMIA
Metabolism and nutrition disorders
MedDRA13.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected18 at risk
EG003
IMPAIRED FASTING GLUCOSE
Metabolism and nutrition disorders
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected18 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected18 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected18 at risk
EG003
MUSCULOSKELETAL CHEST PAIN
Musculoskeletal and connective tissue disorders
MedDRA13.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected18 at risk
EG003
MYALGIA
Musculoskeletal and connective tissue disorders
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected18 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected18 at risk
EG003
RHEUMATOID ARTHRITIS
Musculoskeletal and connective tissue disorders
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected18 at risk
EG003
SYNOVITIS
Musculoskeletal and connective tissue disorders
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected18 at risk
EG003
ACOUSTIC NEURITIS
Nervous system disorders
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected18 at risk
EG003
CARPAL TUNNEL SYNDROME
Nervous system disorders
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected18 at risk
EG003
DIZZINESS
Nervous system disorders
MedDRA13.1
Systematic Assessment
EG0002 events2 affected19 at risk
EG0011 events1 affected19 at risk
EG0021 events1 affected18 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected19 at risk
EG0022 events1 affected18 at risk
EG003
HYPOAESTHESIA
Nervous system disorders
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected18 at risk
EG003
PARAESTHESIA
Nervous system disorders
MedDRA13.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected18 at risk
EG003
PRESYNCOPE
Nervous system disorders
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected18 at risk
EG003
SYNCOPE
Nervous system disorders
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected18 at risk
EG003
TRIGEMINAL NEURALGIA
Nervous system disorders
MedDRA13.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected18 at risk
EG003
INSOMNIA
Psychiatric disorders
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected18 at risk
EG003
POLLAKIURIA
Renal and urinary disorders
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected18 at risk
EG003
MENSTRUATION DELAYED
Reproductive system and breast disorders
MedDRA13.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected18 at risk
EG003
OROPHARYNGEAL PAIN
Respiratory, thoracic and mediastinal disorders
MedDRA13.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected18 at risk
EG003
RESPIRATORY DISORDER
Respiratory, thoracic and mediastinal disorders
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected18 at risk
EG003
ERYTHEMA
Skin and subcutaneous tissue disorders
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected19 at risk
EG0022 events1 affected18 at risk
EG003
HYPERHIDROSIS
Skin and subcutaneous tissue disorders
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected18 at risk
EG003
HYPERKERATOSIS
Skin and subcutaneous tissue disorders
MedDRA13.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected18 at risk
EG003
PRURITUS
Skin and subcutaneous tissue disorders
MedDRA13.1
Systematic Assessment
EG0002 events1 affected19 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected18 at risk
EG003
HYPOTENSION
Vascular disorders
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected19 at risk
EG0024 events3 affected18 at risk
EG003
ORTHOSTATIC HYPOTENSION
Vascular disorders
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected18 at risk
EG003
PERIPHERAL COLDNESS
Vascular disorders
MedDRA13.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected18 at risk
EG003
PHLEBITIS
Vascular disorders
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected18 at risk
EG003
GASTRITIS
Gastrointestinal disorders
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected18 at risk
EG003
CHOLELITHIASIS
Hepatobiliary disorders
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected18 at risk
EG003
CYTOLYTIC HEPATITIS
Hepatobiliary disorders
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected18 at risk
EG003
BLOOD PRESSURE INCREASED
Investigations
MedDRA13.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected18 at risk
EG003
The study was terminated prematurely due to lack of efficacy.