VA111913 Dysmenorrhoea Efficacy and Safety Proof of Concept - Full Text View

Purpose

The purpose of the study is to investigate how effective VA111913 is at preventing menstrual pain in women with primary dysmenorrhoea.

Condition	Intervention	Phase
Primary Dysmenorrhea	Drug: VA111913 TS and placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Menstruation

U.S. FDA Resources

Further study details as provided by Vantia Ltd:

Primary Outcome Measures:

Pain assessed using standard scoring system [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety assessed by laboratory findings, vital signs, ECGs and AEs [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Assessment of treatment effectiveness [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Requirement for rescue medication [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Assessment of menstrual bleeding [ Time Frame: 3 months ] [ Designated as safety issue: No ]
PK assessments [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment:	146
Study Start Date:	August 2009
Study Completion Date:	November 2010
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: VA111913 100mg twice daily	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
Placebo Comparator: Starch pill	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

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

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00963053

Locations

United States, Arizona
Pivotal Research Centers
Peoria, Arizona, United States, 85381
United States, Texas
Premier Research Group
Austin, Texas, United States, 78705
United States, Utah
Jean Brown Research
Salt Lake City, Utah, United States, 84124
United Kingdom
Bio-Kinetic Europe Limited
Belfast, United Kingdom, BT2 7BA

Sponsors and Collaborators

Vantia Ltd

Investigators

Principal Investigator:	David Bell	Bio-Kinetic Europe Limited
Principal Investigator:	Stephen E Daniels	PREMIER RESEARCH GROUP
Principal Investigator:	Vernon Yamashiro	Jean Brown Research
Principal Investigator:	Louise Taber	Pivotal Research Centers

More Information

No publications provided

Responsible Party:	Dr Stephen Daniels / Executive Medical Director, Premier Research Group
ClinicalTrials.gov Identifier:	NCT00963053 History of Changes
Other Study ID Numbers:	913-002
Study First Received:	August 17, 2009
Last Updated:	November 15, 2010
Health Authority:	United States: Food and Drug Administration United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Vantia Ltd:

dysmenorrhoea
dysmenorrhea
pain
pre-emptive

Additional relevant MeSH terms:

Dysmenorrhea
Menstruation Disturbances
Pathologic Processes

Pelvic Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on June 17, 2013