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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2007-001139-71-IT |
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Date of registration:
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16/10/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of ABT-894, Duloxetine and Placebo in Subjects with Diabetic Neuropathic Pain - ND
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Scientific title:
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A Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of ABT-894, Duloxetine and Placebo in Subjects with Diabetic Neuropathic Pain - ND |
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Date of first enrolment:
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27/11/2007 |
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Target sample size:
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275 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-001139-71 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: yes
Other: no
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Phase:
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Countries of recruitment
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France
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Germany
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Italy
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
Look at Synopsis Main Inclusion Criteria (1-12)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Look at Synopsis:Main Exclusion Criteria(1-18)
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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diabetic neuropathic pain
MedDRA version: 9.1
Level: LLT
Classification code 10054095
Term: Neuropathic pain
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Intervention(s)
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Product Name: ABT-894
Product Code: ABT-894
Pharmaceutical Form: Capsule, hard
CAS Number: 876170-44-4
Current Sponsor code: A-422894.112
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Trade Name: CYMBALTA
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Duloxetine hydrochloride
CAS Number: 136434-34-9
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 60-
Product Name: ABT-894
Product Code: ABT-894
Pharmaceutical Form: Capsule, hard
CAS Number: 876170-44-4
Current Sponsor code: A-422894.112
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: ABT-894
Product Code: ABT-894
Pharmaceutical Form: Capsule, hard
CAS Number: 876170-44-4
Current Sponsor code: A-422894.112
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Main Objective: The primary objective of this study is to compare the analgesic efficacy and safety of ABT?894 (1 mg, 2 mg, and 4 mg capsules) administered twice daily (BID), to placebo in the treatment of diabetic neuropathic pain (DNP). Duloxetine 60 mg administered once daily (QD) will be assessed for assay sensitivity.
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Primary end point(s): The primary efficacy measure will be weekly mean of 24-hour Average Pain Score (abbreviated as 24-hour average pain score) measured by the 11-point Likert Scale and calculated from subject's daily diary.
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Secondary Objective: To explore the pharmacokinetic and pharmacogenetic characteristics of ABT-894 in the Diabetic Neuropathic Pain population
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Secondary ID(s)
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2007-001139-71-FR
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M06-850
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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