VA111913 Dysmenorrhoea Efficacy and Safety Proof of Concept
Primary Purpose
Primary Dysmenorrhea
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
VA111913 TS and placebo
Sponsored by
About this trial
This is an interventional treatment trial for Primary Dysmenorrhea focused on measuring dysmenorrhoea, dysmenorrhea, pain, pre-emptive
Eligibility 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
Sites / Locations
- Pivotal Research Centers
- Premier Research Group
- Jean Brown Research
- Bio-Kinetic Europe Limited
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
VA111913 100mg twice daily
Starch pill
Arm Description
Outcomes
Primary Outcome Measures
Pain assessed using standard scoring system
Secondary Outcome Measures
Safety assessed by laboratory findings, vital signs, ECGs and AEs
Assessment of treatment effectiveness
Requirement for rescue medication
Assessment of menstrual bleeding
PK assessments
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00963053
Brief Title
VA111913 Dysmenorrhoea Efficacy and Safety Proof of Concept
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vantia Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to investigate how effective VA111913 is at preventing menstrual pain in women with primary dysmenorrhoea.
Detailed Description
Dysmenorrhoea is suffered by between 50% and 90% of women of child bearing age. Up to 30% of these women are non-responsive to the currently prescribed therapies. As such it represents an area of unmet medical need. VA111913 inhibits vasopressin-induced contractions of human myometrial strips and human myometrial blood vessels in vitro. By this mechanism, it is anticipated that the pain of dysmenorrhoea, a condition in which myometrial tone and contractions are increased and blood flow to the uterus is decreased compared to normal, may be reduced.
Subjects will be dosed with VA111913 TS and placebo in a cross over design during two consecutive menstrual cycles. They will be dosed for up to a maximum of 6 days, beginning 2 days before the onset of menstruation. Subjects will then assess the menstrual pain, bleeding and amount of analgesia required to treat symptoms during each cycle
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Dysmenorrhea
Keywords
dysmenorrhoea, dysmenorrhea, pain, pre-emptive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
146 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VA111913 100mg twice daily
Arm Type
Experimental
Arm Title
Starch pill
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
VA111913 TS and placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Pain assessed using standard scoring system
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Safety assessed by laboratory findings, vital signs, ECGs and AEs
Time Frame
3 months
Title
Assessment of treatment effectiveness
Time Frame
3 months
Title
Requirement for rescue medication
Time Frame
3 months
Title
Assessment of menstrual bleeding
Time Frame
3 months
Title
PK assessments
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Bell
Organizational Affiliation
Bio-Kinetic Europe Limited
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephen E Daniels
Organizational Affiliation
Premier Research Group plc
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vernon Yamashiro
Organizational Affiliation
Jean Brown Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Louise Taber
Organizational Affiliation
Pivotal Research Centers
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pivotal Research Centers
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Premier Research Group
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Jean Brown Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Bio-Kinetic Europe Limited
City
Belfast
ZIP/Postal Code
BT2 7BA
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
VA111913 Dysmenorrhoea Efficacy and Safety Proof of Concept
We'll reach out to this number within 24 hrs