Trial record 7 of 36 for:    vulvodynia

A Trial of Gabapentin in Vulvodynia: Biological Correlates of Response

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by University of Tennessee
Sponsor:
Collaborator:
University of Tennessee Health Science Center
Information provided by (Responsible Party):
Candace Brown, MSN, Pharm.D., University of Tennessee
ClinicalTrials.gov Identifier:
NCT01301001
First received: May 13, 2010
Last updated: October 13, 2014
Last verified: October 2014
  Purpose

The Specific aims of this project are to (1) test the prediction that pain from tampon insertion (primary outcome measure) is lower in PVD patients when treated with gabapentin compared to when treated with placebo. Secondary outcome measures include intercourse pain and 24-hour pain and (2)perform a mechanism-based analysis of gabapentin effectiveness, and to gain insight into the underlying pathophysiology of subtypes of PVD that may lead to more specific treatment options.


Condition Intervention
Vulvodynia
Drug: Gabapentin extended-release

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Controlled Trial of Gabapentin in Vulvodynia: Biological Correlates of Response

Resource links provided by NLM:


Further study details as provided by University of Tennessee:

Primary Outcome Measures:
  • The primary outcome measure of this project are to test the prediction that pain from tampon insertion is lower in PVD patients when treated with gabapentin compared to when treated with placebo. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    The immediate goal is to conduct a multicenter, randomized controlled trial (RCT) of gabapentin treatment for PVD, and which will also provide critical data on a new PVD-testing and response paradigm, as well as on characteristics that may define subtypes of PVD.


Secondary Outcome Measures:
  • The secondary outcome measure is to perform a mechanism-based analysis of gabapentin effectiveness, and to gain insight into the underlying pathophysiology of subtypes of PVD that may lead to more specific treatment options. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    The Long-range goals of this project are to explicate the underlying pathophysiologic mechanisms of PVD, and to use this knowledge to create evidence-based differential diagnoses of subtypes of PVD and to individualize treatments for each subtype.


Estimated Enrollment: 120
Study Start Date: August 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: gabapentin extended-release
This is a 18-week, randomized, double-blind, placebo-controlled, two-treatment, two-period crossover design. A parallel group design was considered but excluded because a crossover design provides the ability to compare several treatment regimens in the same subject and allows for comparison at the individual rather than group level. During the first four weeks of each 8-week treatment period, the dose will be escalated toward a maximal tolerated dose or the target ceiling dose of 3600 mg/d, whichever is reached first.
Drug: Gabapentin extended-release
Titration schedule: Week 0: 600 mg/d; Week 1: 1200 mg/d; Week 2: 1800 mg/d; Week 3: 2400 mg/d; Week 4: 3000 mg/d. If side effects are intolerable or do not diminish within 3-4 days, the AM dose will be decreased by 600 mg, and an increase will be attempted one more time. If this next increase again results in intolerable side effects, the study drug will be decreased to the previous dose (maximal tolerated dose) and continued for the remainder of the study (a minimal dose of 1200 mg/d will be permitted).
Other Name: Gralise
Placebo Comparator: Placebo (sugar pill)
This is a 18-week, randomized, double-blind, placebo-controlled, two-treatment, two-period crossover design. A parallel group design was considered but excluded because a crossover design provides the ability to compare several treatment regimens in the same subject and allows for comparison at the individual rather than group level. During the first four weeks of each 8-week treatment period, the dose will be escalated toward a maximal tolerated dose or the target ceiling dose of 3600 mg/d, whichever is reached first. Matching placebo capsules will be similarly administered. An investigational new drug (IND) application will be filed with the FDA.
Drug: Gabapentin extended-release
Titration schedule: Week 0: 600 mg/d; Week 1: 1200 mg/d; Week 2: 1800 mg/d; Week 3: 2400 mg/d; Week 4: 3000 mg/d. If side effects are intolerable or do not diminish within 3-4 days, the AM dose will be decreased by 600 mg, and an increase will be attempted one more time. If this next increase again results in intolerable side effects, the study drug will be decreased to the previous dose (maximal tolerated dose) and continued for the remainder of the study (a minimal dose of 1200 mg/d will be permitted).
Other Name: Gralise

Detailed Description:

This is a 18-week, randomized, double-blind, placebo-controlled, two-treatment, two-period crossover design, where 120 women between 18 of age and older who report insertional dyspareunia, pain with tampon insertion, and tenderness localized to the vulvar vestibule will be enrolled in the study. Electronically entered daily diaries will be used to determine if pain is lower in PVD subjects when treated with gabapentin (up to 3600 mg/d) compared to when treated with placebo. Biological measurements will include assessment of allodynia and hyperalgesia from capsaicin administration, muscle tension using a vaginal pressure algometer, number of tender points by clinical examination, and changes in blood pressure, pulse and heart rate variability. . The Long-range goals of this project are to explicate the underlying pathophysiologic mechanisms of PVD, and to use this knowledge to create evidence-based differential diagnoses of subtypes of PVD and to individualize treatments for each subtype. The immediate goal is to conduct a multicenter, randomized controlled trial (RCT) of gabapentin treatment for PVD, and which will also provide critical data on a new PVD-testing and response paradigm, as well as on characteristics that may define subtypes of PVD. Gabapentin, an anticonvulsant with analgesic, anxiolytic, and antispasmotic effects, was selected because of its efficacy in treating other neuropathic pain conditions.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Women who are 18 years of age and older, as long as no vaginal atrophy is present. If vaginal atrophy is present, then topical hormone replacement can be provided for a minimum of 6 weeks and then she must be re-screened to be eligible,
  2. Greater than 3 continuous months of insertional (entryway) dyspareunia, pain to touch, or both with tampon insertion (modified 'Friedrich's Criteria', and
  3. an average pain level of "4" or greater on the 11-point tampon test (0 = no pain at all; 10 = worse pain ever) during the 2-week screening period must be exhibited.

(One tampon will be inserted each week). 4.) Must report pain with the "Tampon Insertion Pain" Test at visit 1

Exclusion Criteria:

  1. Other vulvar conditions, including dermatoses, vulvitis, vulvar papillomatosis, or atrophic vaginitis (presence of a maturation index)
  2. previous vestibulectomy
  3. active vaginal infection (positive Affirm ™ VPIII microbial identification test)
  4. pregnancy or at risk for pregnancy and not using a reliable birth control method for at least 3 months prior to entering the study
  5. any unstable medical condition, including renal impairment (creatinine clearance of ≤60 mL/min, BUN > 30mg/dL, serum creatinine > 2 mg/dL), significant hematological disease (leukopenia [WBC < 3.0 x 10-3µl, leukocytosis [WBC >20.0 x 10-3μl], neutropenia [ABS < 1.50 x 10-3 μl, <20%]), (thrombocytopenia [platelets < 100,000 μl], anemia [HCT < 27%, HBG <8 g/dL, RBC <3 x 10-6]), cardiovascular disease (cardiac conduction disturbance, CHF, hypertension [140/90]), hepatic insufficiency (serum AST, ALT, or ALP ≥ 3 times upper limit of normal), neurological disorder (seizures, syncopal episodes, peripheral neuropathy, severe pain other than that caused by vulvodynia), autoimmune disease, or respiratory illness
  6. psychiatric disorder, including history of major depressive disorder or substance abuse disorder within the past 6 months, a score of > 12 on the depression subscale of the Hospital Anxiety and Depression Scale (HADS), indicting a major depressive episode (35,36), a serious risk of suicide, or lifetime history of psychosis, hypomania or mania
  7. multiple allergies
  8. use of benzodiazepines, opiates, muscle relaxants, tricyclic antidepressants (TCAs), serotonin-norepinephrine reuptake inhibitors (SNRIs) or CNS stimulants (including methylphenidate, amphetamine dextroamphetamine) within 2 weeks of randomization and during the study
  9. use of certain herbal agents within 2 weeks of randomization and during the study, including ginkgo biloba, evening primrose, St. John's Wort, Valerian, kava kava)
  10. topical lidocaine use
  11. Subjects, who are diagnosed with coexisting vaginismus, fibromyalgia and/or interstitial cystitis, must have greater vulvar pain than their coexisting conditions or they will not be eligible for study participation
  12. Subject who have previously taken gabapentin or Lyrica but discontinued the medication due to side effects are not eligible
  13. Subjects with active infections (Candida, BV, trichomonas, chlamydia, GC and HSV via Affirm/culture) must be treated and re-screened to eligible for participation
  14. Subjects with 10% or greater parabasal cells and/or vaginal atrophy can be provided with topical hormone replacement for a minimum of 6 weeks and then must be re-screened to be eligible
  15. Subjects who have had gastric bypass surgery are ineligible for study participation due to drug absorption problems
  16. HPV/abnormal Pap is not exclusionary
  17. Ongoing counseling and/or physical therapy is not exclusionary
  18. Subjects who report signs of mixed Vulvodynia (spontaneous/provoked, localized, generalized) during prescreening will not be excluded
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01301001

Contacts
Contact: Leslie Rawlinson 901-448-6693 lrawlins@uthsc.edu
Contact: Leslie Rawlinson 901-448-1500 lrawlins@uthsc.edu

Locations
United States, New Jersey
Rutgers - Robert Wood Johnson Medical School Recruiting
New Brunswick, New Jersey, United States, 08901-1962
Contact: Gloria A Bachmann, M.D.    732-235-7353    bachmaga@umdnj.edu   
Principal Investigator: Gloria A Bachmann, M.D.         
United States, New York
University of Rochester School of Medicine and Dentistry Active, not recruiting
Rochester, New York, United States, 14642-0002
United States, Tennessee
Clinical Research Center Recruiting
Memphis, Tennessee, United States, 38104
Contact: Candace S Brown, MSN, PharmD    901-412-4341    csbrown@uthsc.edu   
Contact: Leslie A Rawlinson    901-448-6693    lrawlins@uthsc.edu   
Principal Investigator: Candace S Brown, MSN, PharmD         
Sponsors and Collaborators
University of Tennessee
University of Tennessee Health Science Center
Investigators
Principal Investigator: Candace S Brown, MSN, PharmD University of Tennessee Health Science Center
Principal Investigator: David C Foster, M.D. University of Rochester School of Medicine and Dentistry
Principal Investigator: Gloria A Bachmann, M.D. Rutgers - Robert Wood Johnson Medical School
  More Information

Additional Information:
No publications provided

Responsible Party: Candace Brown, MSN, Pharm.D., Professor, Departments of Clinical Pharmacy, Psychiatry and Obstetrics/Gynecology, University of Tennessee
ClinicalTrials.gov Identifier: NCT01301001     History of Changes
Other Study ID Numbers: CSBrown Vulvodynia
Study First Received: May 13, 2010
Last Updated: October 13, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by University of Tennessee:
Vulvodynia

Additional relevant MeSH terms:
Vulvodynia
Genital Diseases, Female
Vulvar Diseases
Gabapentin
Analgesics
Anti-Anxiety Agents
Anti-Dyskinesia Agents
Anticonvulsants
Antimanic Agents
Antiparkinson Agents
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 20, 2014