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Trial record 82 of 135 for:    AMITRIPTYLINE

Novel Topical Therapies for the Treatment of Genital Pain (Topicals)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02099006
Recruitment Status : Completed
First Posted : March 28, 2014
Results First Posted : July 15, 2016
Last Update Posted : July 15, 2016
Sponsor:
Collaborator:
Mae Stone Goode Foundation
Information provided by (Responsible Party):
Adrienne Bonham, University of Rochester

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Female Genital Diseases
Interventions Drug: Amitriptyline
Drug: Baclofen
Drug: Ketoprofen
Drug: Ketamine
Drug: Loperamide
Drug: Gabapentin
Drug: placebo
Enrollment 9
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Study Participants
Hide Arm/Group Description

Each study subject was sequentially exposed to each of the study drugs and the placebo in a random order. The study is designed as a double blinded, crossover study.

Amitriptyline 2%/ Baclofen 2%: Topical application of the drug at a 2% concentration in combination with 2% Baclofen

Ketoprofen: To be applied topically at a 10% concentration

Ketamine: To be applied topically at a 10% concentration

Loperamide: To be applied topically at a 5% concentration

Gabapentin: To be applied topically at a 6% concentration

Period Title: Overall Study
Started 9
Received Placebo 9
Received Amitriptyline/ Baclofen 7
Received Ketoprofen 3
Received Loperamide 7
Received Ketamine 6
Received Gabapentin 8
Completed 8
Not Completed 1
Arm/Group Title All Study Participants
Hide Arm/Group Description

Each study subject will be sequentially exposed to each of the study drugs and the placebo in a random order. The study is designed as a double blinded, crossover study.

Amitriptyline/ Baclofen: Topical application of the drug at a 2% concentration in combination with 2% Baclofen

Ketoprofen: To be applied topically at a 10% concentration

Ketamine: To be applied topically at a 10% concentration

Loperamide: To be applied topically at a 5% concentration

Gabapentin: To be applied topically at a 6% concentration

Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
<=18 years
0
   0.0%
Between 18 and 65 years
9
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
9
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants
9
1.Primary Outcome
Title Reduction in Daily Genital Pain.
Hide Description Each subject was asked to keep a symptom diary recording her daily genital pain, measured on a 10 point Likert scale. A score of "0" was defined as no pain and a score of "10" was defined as worst imaginable pain. These daily values were collected and a mean pain score for the period of treatment was calculated.
Time Frame 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
For each placebo entry the data is limited to include only those participates who also received the named intervention.
Arm/Group Title Medications Placebo
Hide Arm/Group Description:

Each study subject will be sequentially exposed to each of the study drugs and the placebo in a random order. The study is designed as a double blinded, crossover study.

Amitriptyline: Topical application of the drug at a 2% concentration in combination with 2% Baclofen

Baclofen: Used topically at 2% concentration in combination with 2% amitriptyline

Ketoprofen: To be applied topically at a 10% concentration

Ketamine: To be applied topically at a 10% concentration

Loperamide: To be applied topically at a 5% concentration

Gabapentin: To be applied topically at a 6% concentration

The compounding base alone will be used as a placebo. Each participant will be given each drug and the placebo sequentially in random order.

placebo: Compounding base to be used alone as a placebo

Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
Loperamide 2.4  (1.94) 2.92  (2.3)
Ketamine 3.42  (2.45) 2.77  (2.46)
Gabapentin 3.70  (2.92) 3.41  (2.55)
amtriptyline/baclofen 3.87  (2.74) 3.61  (2.68)
ketoprofen 5.05  (3.34) 5.05  (3.45)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Medications, Placebo
Comments Null hypothesis - that the improvement in daily genital pain would be no different with the daily application of loperamide than with the daily application of a placebo cream.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.30
Comments [Not Specified]
Method t-test, 2 sided
Comments Paired T test
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Medications, Placebo
Comments Null hypothesis - that the improvement in daily genital pain would be no different with the daily application of ketamine than with the daily application of a placebo cream.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.33
Comments [Not Specified]
Method t-test, 2 sided
Comments Paired
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Medications, Placebo
Comments Null hypothesis - that the improvement in daily genital pain would be no different with the daily application of gabapentin than with the daily application of a placebo cream.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.65
Comments [Not Specified]
Method t-test, 2 sided
Comments paired
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Medications, Placebo
Comments Null hypothesis - that the improvement in daily genital pain would be no different with the daily application of amitriptyline and baclofen than with the daily application of a placebo cream.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.25
Comments [Not Specified]
Method t-test, 2 sided
Comments Paired
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Medications, Placebo
Comments Null hypothesis - that the improvement in daily genital pain would be no different with the daily application of ketoprofen than with the daily application of a placebo cream.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments [Not Specified]
Method t-test, 2 sided
Comments Paired
2.Secondary Outcome
Title Reduction in Tampon Test Pain
Hide Description Reduction in the pain, as measured on a 10 point Likert scale, associated with the insertion and removal of a tampon. This is a validated surrogate for pain associated with intercourse. Subjects were asked to insert and remove a tampon each week and report the degree of pain associated with this. A score of "0" was defined as no pain, and a score of "10" was defined as worst imaginable pain.
Time Frame 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
For each placebo entry the data is limited to include only those participates who also received the named intervention.
Arm/Group Title Medications Placebo
Hide Arm/Group Description:

Each study subject will be sequentially exposed to each of the study drugs and the placebo in a random order. The study is designed as a double blinded, crossover study.

Amitriptyline: Topical application of the drug at a 2% concentration in combination with 2% Baclofen

Baclofen: Used topically at 2% concentration in combination with 2% amitriptyline

Ketoprofen: To be applied topically at a 10% concentration

Ketamine: To be applied topically at a 10% concentration

Loperamide: To be applied topically at a 5% concentration

Gabapentin: To be applied topically at a 6% concentration

The compounding base alone will be used as a placebo. Each participant will be given each drug and the placebo sequentially in random order.

placebo: Compounding base to be used alone as a placebo

Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
loperamide 4.71  (2.75) 5.29  (3.21)
ketamine 5.92  (3.56) 5.92  (3.00)
gabapentin 5.125  (3.57) 4.875  (3.19)
ketoprofen 6.17  (3.18) 6.0  (3.46)
amitriptyline/baclofen 5.43  (2.75) 5.36  (3.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Medications, Placebo
Comments Null hypothesis - that the improvement in tampon test pain would be no different with the daily application of loperamide cream than with the daily application of a placebo cream.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.31
Comments [Not Specified]
Method t-test, 2 sided
Comments paired
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Medications, Placebo
Comments Null hypothesis - that the improvement in tampon test pain would be no different with the daily application of ketamine cream than with the daily application of a placebo cream.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1
Comments [Not Specified]
Method t-test, 2 sided
Comments Paired
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Medications, Placebo
Comments Null hypothesis - that the improvement in tampon test pain would be no different with the daily application of gabapentin cream than with the daily application of a placebo cream.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.66
Comments [Not Specified]
Method t-test, 2 sided
Comments Paired
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Medications, Placebo
Comments Null hypothesis - that the improvement in tampon test pain would be no different with the daily application of ketoprofen cream than with the daily application of a placebo cream.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.42
Comments [Not Specified]
Method t-test, 2 sided
Comments Paired
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Medications, Placebo
Comments Null hypothesis - that the improvement in tampon test pain would be no different with the daily application of amitriptyline/baclofen cream than with the daily application of a placebo cream.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.79
Comments [Not Specified]
Method t-test, 2 sided
Comments Paired
Time Frame 1.5 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Medications Placebo
Hide Arm/Group Description

Each study subject will be sequentially exposed to each of the study drugs and the placebo in a random order. The study is designed as a double blinded, crossover study.

Amitriptyline: Topical application of the drug at a 2% concentration in combination with 2% Baclofen

Baclofen: Used topically at 2% concentration in combination with 2% amitriptyline

Ketoprofen: To be applied topically at a 10% concentration

Ketamine: To be applied topically at a 10% concentration

Loperamide: To be applied topically at a 5% concentration

Gabapentin: To be applied topically at a 6% concentration

The compounding base alone will be used as a placebo. Each participant will be given each drug and the placebo sequentially in random order.

placebo: Compounding base to be used alone as a placebo

All-Cause Mortality
Medications Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Medications Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/9 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Medications Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/9 (0.00%) 
The small number of patients recruited left this study underpowered to uncover significant effects with the medications studied.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Adrienne Bonham MD
Organization: University of Rochester
Phone: (585) 273-3314
EMail: adrienne_bonham@urmc.rochester.edu
Layout table for additonal information
Responsible Party: Adrienne Bonham, University of Rochester
ClinicalTrials.gov Identifier: NCT02099006     History of Changes
Other Study ID Numbers: 46905
First Submitted: March 25, 2014
First Posted: March 28, 2014
Results First Submitted: July 14, 2016
Results First Posted: July 15, 2016
Last Update Posted: July 15, 2016