Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00276068
Status:
COMPLETED
Last Update Posted:
2007-11-14
First Post:
2006-01-11
Brief Title:
Vulvar Vestibulitis Clinical Trial Desipramine-Lidocaine
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
Vulvar Vestibulitis Trial Desipramine-Lidocaine
Status:
COMPLETED
Status Verified Date:
2007-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Vulvar Vestibulitis Clinical Trial VVCT a randomized placebo-controlled double blinded clinical trial We will study the clinical efficacy of four medical treatments for vulvar vestibulitis topical lidocaine oral desipramine combined lidocaine and desipramine and placebo cream and capsules Desipramine is a tricyclic antidepressant commonly used by clinicians for treatment of several chronic pain conditions that demonstrates an optimal side effect profile compared to other tricyclic antidepressants Topical lidocaine has also been found to be beneficial for vulvar vestibulitis treatment in small studies It is hypothesized that the combined use of oral desipramine and topical lidocaine will be more therapeutically effective than either one by itself and better than placebo
Detailed Description:
The Vulvar Vestibulitis Clinical Trial VVCT is a randomized placebo-controlled double-blinded clinical trial to study the clinical efficacy of four medical treatments for vulvar vestibulitis 1 topical lidocaine 2 oral desipramine 3 combined lidocaine and desipramine and 4 placebo cream and capsules The duration of study drug will last 12 weeks with post-intervention follow-up at 6 and 12 months We plan to enroll 128 subjects from the university-based clinical program at the University of Rochester URPrimary outcome variable will compare the reported pain of the Tampon Test mean of Weeks -2 -1 and 0 prior to randomization to the reported pain of Tampon Test mean of Weeks 10 11 and 12 The dependent primary outcome variable will be defined as the percent change of mean Tampon test pain of Weeks 10 11 and 12 from Weeks -2 -1 and 0 The primary analysis of this 2X2 factorial design will involve fitting an Analysis of Covariance ANCOVA regression model to the percent change of mean Tampon test pain with the two treatment variables as the predictors while adjusting for the covariate age We will test if the interaction between the two treatments in the ANCOVA model is significant at the 05 level If the interaction effect is not significant it will be dropped from the model and the conclusion will be drawn from the model with main effects only If significant the model with interactions will be adopted SAS PROC GLM will be used in the analysis
In the case of non-significant interaction the primary analysis will be based on the ANCOVA model with main effects of treatments and adjusting for age Since there are two treatments under investigation the primary analysis will use the Bonferroni correction ie will set alpha level of 0025 two-sided to determine statistical significance The significance of the main effect of each treatment will be assessed by t-tests in the ANCOVA model The aim of the primary analysis is to determine whether each treatment is superior to placebo and if both hypotheses hold the double treatment therapy will be most effective under the additive effect assumption of the ANCOVA model The ANCOVA model compares all subjects who receive that treatment with all subjects who do not irrespective of whether they receive the other treatment after adjusting for the other treatment and age of subject and is more powerful in finding individual treatment effects in the study
If interaction between treatments is significant the ANCOVA model with interaction will estimate the treatment effects for each of the four groups This model is able to test all 6 contrasts between the four combinations A hierarchical gatekeeping testing strategy to maintain a family-wise error rate will be adopted as the following the first stage will compare desipramine or lidocaine individually to placebo with multiplicity-adjusted p-values If a significant difference one or both null hypotheses rejected is found for either or both individual agents then the analysis will proceed to the second-stage of hypothesis which will compare the effects of the active desipramineactive lidocaine treatment to the double placebo If a significant difference null hypothesis rejected is found for combined therapy over placebo based on the multiplicity-adjusted p-value then the final tertiary stage of comparison will be performed comparing combined therapy to individual therapy In the hierarchical gatekeeping testing procedures inferences in each stage depend on the acceptance or rejection of null hypotheses in all previously stages and each stage serves as a gatekeeper for the stages later in the sequence In our strategy for the model with significant interaction effect if at least one hypothesis has been rejected then the next stage of hypotheses will be tested and the family-wise error rate is controlled at the 05 level
Secondary analyses will include subset analysis comparison of the double-active treatment group against the others placebo and the single-treatment groups on percent change of mean Tampon test as well as standardized pain measures such as the Brief Pain Inventory and the McGill Pain Questionnaire This is to explore if the active desipramineactive lidocaine treatment has more advantages that may not be shown in the ANCOVA model The secondary analysis is to explore supportive evidence to the primary objective of this trial and no confirmatory conclusions are needed In the secondary analysis confidence intervals and statistical tests are of exploratory nature and no claims are intended
Primary and secondary outcome variables will be analyzed according to a modified intention to treat with last observation carried forward The sample analyzed for the primary outcome will include the first three or fewer pre-randomization Tampon Test measures and the last three or fewer post-randomization Tampon Test measures up to and including study Week 12 The subject sample analyzed for drug safetyside effects will include all subjects who have taken at least one dose of study drug
In the case of non-significant interaction the primary analysis will be based on the ANCOVA model with main effects of treatments and adjusting for age Since there are two treatments under investigation the primary analysis will use the Bonferroni correction ie will set alpha level of 0025 two-sided to determine statistical significance The significance of the main effect of each treatment will be assessed by t-tests in the ANCOVA model The aim of the primary analysis is to determine whether each treatment is superior to placebo and if both hypotheses hold the double treatment therapy will be most effective under the additive effect assumption of the ANCOVA model The ANCOVA model compares all subjects who receive that treatment with all subjects who do not irrespective of whether they receive the other treatment after adjusting for the other treatment and age of subject and is more powerful in finding individual treatment effects in the study
If interaction between treatments is significant the ANCOVA model with interaction will estimate the treatment effects for each of the four groups This model is able to test all 6 contrasts between the four combinations A hierarchical gatekeeping testing strategy to maintain a family-wise error rate will be adopted as the following the first stage will compare desipramine or lidocaine individually to placebo with multiplicity-adjusted p-values If a significant difference one or both null hypotheses rejected is found for either or both individual agents then the analysis will proceed to the second-stage of hypothesis which will compare the effects of the active desipramineactive lidocaine treatment to the double placebo If a significant difference null hypothesis rejected is found for combined therapy over placebo based on the multiplicity-adjusted p-value then the final tertiary stage of comparison will be performed comparing combined therapy to individual therapy In the hierarchical gatekeeping testing procedures inferences in each stage depend on the acceptance or rejection of null hypotheses in all previously stages and each stage serves as a gatekeeper for the stages later in the sequence In our strategy for the model with significant interaction effect if at least one hypothesis has been rejected then the next stage of hypotheses will be tested and the family-wise error rate is controlled at the 05 level
Secondary analyses will include subset analysis comparison of the double-active treatment group against the others placebo and the single-treatment groups on percent change of mean Tampon test as well as standardized pain measures such as the Brief Pain Inventory and the McGill Pain Questionnaire This is to explore if the active desipramineactive lidocaine treatment has more advantages that may not be shown in the ANCOVA model The secondary analysis is to explore supportive evidence to the primary objective of this trial and no confirmatory conclusions are needed In the secondary analysis confidence intervals and statistical tests are of exploratory nature and no claims are intended
Primary and secondary outcome variables will be analyzed according to a modified intention to treat with last observation carried forward The sample analyzed for the primary outcome will include the first three or fewer pre-randomization Tampon Test measures and the last three or fewer post-randomization Tampon Test measures up to and including study Week 12 The subject sample analyzed for drug safetyside effects will include all subjects who have taken at least one dose of study drug
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R01HD040123-03 | NIH | None | httpsreporternihgovquickSearch5R01HD040123-03 |