VA111913 Dysmenorrhoea Efficacy and Safety Proof of Concept

Completed

• Source

  -

  Public Title	VA111913 Dysmenorrhoea Efficacy and Safety Proof of Concept
  Scientific Title	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
  Acronym	Sorry, not currently available
  Primary Trial Identifying Number	NCT00963053
  Secondary Identifying Number	Sorry, not currently available
  Source of Record	Information obtained from ClinicalTrials.gov on April 14, 2013
  Source of Record URL	http://clinicaltrials.gov/show/NCT00963053
  Date of Registration	2009-08-17
  Date Last Updated	2010-11-15
  Date Record Refreshed on UKCTG	2013-04-16

• Trial

  -

  Research Question	The purpose of the study is to investigate how effective VA111913 is at preventing menstrual pain in women with primary dysmenorrhoea. (from ClinicalTrials.gov)
  Ethics Approval	Sorry, not currently available
  Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  Design Type	Sorry, not currently available
  Design Details	Sorry, not currently available
  Health Condition(s) or Problem	Primary Dysmenorrhea
  Participants Inclusion Criteria	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
  Participants Exclusion Criteria	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
  Participant Sex	Sorry, not currently available
  Participant Age Range	Sorry, not currently available
  Participant Type	Sorry, not currently available
  Target Sample Size	Sorry, not currently available
  Date of First Enrolment	Sorry, not currently available
  Date of Recruitment End	Sorry, not currently available
  Date of End of Follow-up	Sorry, not currently available
  Trial End Date	Sorry, not currently available
  Recruitment Status	Completed
  Overall Trial Status	Sorry, not currently available
  Countries of Recruitment	United States; United Kingdom
  Nation	Northern Ireland
  Location	Belfast
  Interventions	Drug; VA111913 TS and placebo; VA111913 TS twice daily for a maximum of 6 days during one menstrual cycle followed by placebo twice daily for up to a maximum of 6 days during a second menstrual cycle in a cross over design; VA111913 100mg twice daily; Starch pill
  Primary Outcome Measures	Pain assessed using standard scoring system
  Secondary Outcome Measures	Safety assessed by laboratory findings, vital signs, ECGs and AEs; 3 months; Yes; Assessment of treatment effectiveness; 3 months; No; Requirement for rescue medication; 3 months; No; Assessment of menstrual bleeding; 3 months; No; PK assessments; 3 months; No
  Website	Sorry, not currently available

• Results

  -

  Results Reporting	Sorry, not currently available
  Publications	Sorry, not currently available

• Contact

  -

  Contact for Public Queries	David Bell; Stephen E Daniels; Vernon Yamashiro; Louise Taber Principal Investigator; Principal Investigator; Principal Investigator; Principal Investigator Bio-Kinetic Europe Limited; PREMIER RESEARCH GROUP; Jean Brown Research; Pivotal Research Centers
  Contact for Scientific Queries	Sorry, not currently available

• Sponsor

  -

  Study sponsored by	Vantia Ltd
  Study also sponsored by	Sorry, not currently available
  Primary Sponsor Type	Sorry, not currently available
  Secondary Sponsor Type	Sorry, not currently available

• Funder

  -

  Study funded by	Vantia Ltd
  Funder Type	Sorry, not currently available