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Main
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Note: This record shows only the 20 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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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00963053 |
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Date of registration:
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17/08/2009 |
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Primary sponsor: |
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Public title:
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VA111913 Dysmenorrhoea Efficacy and Safety Proof of Concept
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Scientific title:
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A Randomised, Double Blind, Placebo Controlled, Multicentre, Cross Over Proof of Concept Study to Investigate the Efficacy and Safety of Pre Emptive Administration of Repeated, Oral Doses of VA111913 TS for the Alleviation of Dysmenorrhoea |
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Date of first enrolment:
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August 2009 |
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Target sample size:
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146 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00963053 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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United Kingdom
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United States
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Contacts
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Name:
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David Bell |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bio-Kinetic Europe Limited |
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Name:
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Vernon Yamashiro |
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Address:
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Telephone:
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Email:
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Affiliation:
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Jean Brown Research |
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Name:
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Louise Taber |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pivotal Research Centers |
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Name:
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Stephen E Daniels |
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Address:
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Telephone:
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Email:
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Affiliation:
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PREMIER RESEARCH GROUP |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Women between 18 and 35 years old
- Not pregnant
- History of primary dysmenorrhoea
- Regular menstrual cycles
- Signed informed consent
Exclusion Criteria:
- Known secondary dysmenorrhoea
- Concomitant use of regular prescription or non prescription medications or herbal
remedies
- Any clinically significant medical history or active disease
- Participation in another clinical study in the last 3 months
- Contraindication to chosen rescue medications or allergy to their constituents
- Other protocol defined eligibility criteria may apply
Age minimum:
18 Years
Age maximum:
35 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Primary Dysmenorrhea
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Intervention(s)
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Drug: VA111913 TS and placebo
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Primary Outcome(s)
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Pain assessed using standard scoring system
[Time Frame: 3 months]
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Secondary Outcome(s)
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Assessment of menstrual bleeding
[Time Frame: 3 months]
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Assessment of treatment effectiveness
[Time Frame: 3 months]
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PK assessments
[Time Frame: 3 months]
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Requirement for rescue medication
[Time Frame: 3 months]
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Safety assessed by laboratory findings, vital signs, ECGs and AEs
[Time Frame: 3 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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