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Trial record 28 of 135 for:    AMITRIPTYLINE

Baclofen-Amitriptyline Hydrochloride-Ketamine Gel in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer

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ClinicalTrials.gov Identifier: NCT00516503
Recruitment Status : Completed
First Posted : August 15, 2007
Results First Posted : August 24, 2017
Last Update Posted : August 24, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Conditions Chronic Myeloproliferative Disorders
Leukemia
Lymphoma
Lymphoproliferative Disorder
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Neurotoxicity
Pain
Unspecified Adult Solid Tumor, Protocol Specific
Interventions Drug: baclofen/amitriptyline/ketamine gel
Other: placebo
Enrollment 208
Recruitment Details  
Pre-assignment Details Two-hundred eight patients were enrolled to this study. Five patients cancelled prior to initiating protocol treatment and were therefore this study was analyzed using 203 remaining patients.
Arm/Group Title Baclofen-amitriptyline Hydrochloride-ketamine Placebo
Hide Arm/Group Description Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Baclofen/amitriptyline/ketamine gel: Applied topically. Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Placebo: Applied topically
Period Title: Overall Study
Started 101 102
Completed 101 102
Not Completed 0 0
Arm/Group Title Baclofen-amitriptyline Hydrochloride-ketamine Placebo Total
Hide Arm/Group Description Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Baclofen/amitriptyline/ketamine gel: Applied topically. Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Placebo: Applied topically Total of all reporting groups
Overall Number of Baseline Participants 101 102 203
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 101 participants 102 participants 203 participants
59.5
(41 to 83)
62
(31 to 86)
61
(31 to 86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants 102 participants 203 participants
Female
66
  65.3%
60
  58.8%
126
  62.1%
Male
35
  34.7%
42
  41.2%
77
  37.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 101 participants 102 participants 203 participants
101 102 203
1.Primary Outcome
Title Total Sensory Neuropathy as Measured by the European Organization for Research and Treatment of Cancer [EORTC] Quality of Life [QLQ] - Chemo-induced Peripheral Neuropathy [CIPN20]
Hide Description The scoring algorithm for the parent instrument, the EORTC QLQ-C30, was applied for linearly converting items and subscales of CIPN-20 to 0–100 scales so that a high score corresponds to better condition or less symptom. The primary analysis was the change in sensory neuropathy subscale of the CIPN-20 from baseline to week 4. The area under the curve (AUC) from baseline to week 4 was calculated for each patient's sensory neuropathy score. The average AUC for the placebo arm was compared to the average AUC for the topical amitriptyline HCl/ baclofen/ ketamine arm using a Wilcoxon rank sum test.
Time Frame From baseline to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
There were 26 participants in the BAK arm and 27 in the placebo arm who did not provide primary endpoint data. In the BAK arm, 11 refused due to experiencing an adverse event and 15 refused for non-specified reasons. In the placebo arm, eight refused due to an adverse event, one patient died, and 18 refused for non-specified reasons.
Arm/Group Title Baclofen-amitriptyline Hydrochloride-ketamine Placebo
Hide Arm/Group Description:
Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Baclofen/amitriptyline/ketamine gel: Applied topically.
Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Placebo: Applied topically
Overall Number of Participants Analyzed 75 75
Mean (Standard Deviation)
Unit of Measure: (units on a scale) * week
61.0  (16.22) 60.9  (17.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Baclofen-amitriptyline Hydrochloride-ketamine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.90
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Motor Neuropathy as Measured by the EORTC QLQ-CIPN20 at Baseline and Week 4
Hide Description The scoring algorithm for the parent instrument, the EORTC QLQ-C30, was applied for linearly converting items and subscales of CIPN-20 to 0–100 scales so that a high score corresponds to better condition or less symptom. The secondary analysis was to compare changes from baseline at 4 weeks for the motor neuropathy subscale of the CIPN-20. To analyze this endpoint, the area under the curve (AUC) from baseline to week 4 was calculated for each patient's motor neuropathy score. The average AUC for the placebo arm was compared to the average AUC for the topical amitriptyline HCl/ baclofen/ ketamine arm using a Wilcoxon rank sum test.
Time Frame From Baseline to week 4
Hide Outcome Measure Data
Hide Analysis Population Description
There were 26 participants in the BAK arm and 27 in the placebo arm who did not provide primary endpoint data. In the BAK arm, 11 refused due to experiencing an adverse > event and 15 refused for non-specified reasons. In the placebo arm, eight refused due to an > adverse event, one patient died, and 18 refused for non-specified reasons.
Arm/Group Title Baclofen-amitriptyline Hydrochloride-ketamine Placebo
Hide Arm/Group Description:
Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Baclofen/amitriptyline/ketamine gel: Applied topically.
Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Placebo: Applied topically
Overall Number of Participants Analyzed 75 75
Mean (Standard Deviation)
Unit of Measure: (units on a scale)* week
69.2  (17.15) 70.1  (19.48)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Baclofen-amitriptyline Hydrochloride-ketamine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.50
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title Autonomic Symptoms and Functioning as Measured by the EORTC QLQ-CIPN20 at Baseline and Week 4
Hide Description The scoring algorithm for the parent instrument, the EORTC QLQ-C30, was applied for linearly converting items and subscales of CIPN-20 to 0–100 scales so that a high score corresponds to better condition or less symptom. The secondary analysis was to compare changes from baseline at 4 weeks for the autonomic neuropathy subscale of the CIPN-20. To analyze this endpoint, the area under the curve (AUC) from baseline to week 4 was calculated for each patient's motor neuropathy score. The average AUC for the placebo arm was compared to the average AUC for the topical amitriptyline HCl/ baclofen/ ketamine arm using a Wilcoxon rank sum test.
Time Frame Up to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
There were 26 participants in the BAK arm and 27 in the placebo arm who did not provide primary endpoint data. In the BAK arm, 11 refused due to experiencing an adverse event and 15 refused for non-specified reasons. In the placebo arm, eight refused due to an adverse event, one patient died, and 18 refused for non-specified reasons.
Arm/Group Title Baclofen-amitriptyline Hydrochloride-ketamine Placebo
Hide Arm/Group Description:
Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Baclofen/amitriptyline/ketamine gel: Applied topically.
Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Placebo: Applied topically
Overall Number of Participants Analyzed 75 75
Mean (Standard Deviation)
Unit of Measure: (units on a scale)*week
85.0  (15.47) 86.8  (15.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Baclofen-amitriptyline Hydrochloride-ketamine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.50
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Secondary Outcome
Title Mood States and Total Mood Disturbance as Measured by the Profile of Mood States (POMS)
Hide Description Each mood scale (0 - 100, higher is better mood) will be analyzed as an endpoint along with the total mood disturbance score.
Time Frame At 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baclofen-amitriptyline Hydrochloride-ketamine Placebo
Hide Arm/Group Description:
Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Baclofen/amitriptyline/ketamine gel: Applied topically.
Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Placebo: Applied topically
Overall Number of Participants Analyzed 101 102
Mean (Standard Deviation)
Unit of Measure: units on a scale
POMS Tension-Anxiety Subscale 83.2  (17.09) 83.0  (15.73)
POMS VA Subscale 31.1  (18.42) 33.0  (19.61)
POMS Anger-Hostility Score 87.8  (14.48) 87.7  (12.98)
POMS Confusion-Bewilderment 76.9  (17.58) 77.9  (11.75)
POMS Depression-Dejection Score 86.4  (16.09) 85.8  (15.23)
POMS Fatigue-Inertia Score 67.2  (21.69) 63.6  (22.22)
Mean POMS Score 71.5  (13.27) 71.8  (13.14)
5.Secondary Outcome
Title Pain Severity and Interference as Measured by the Brief Pain Inventory (BPI) at Baseline and Week 4
Hide Description Pain severity, defined by the four items addressing worst, least, and average pain and pain right now as measured by the BPI will be analyzed identical to the primary endpoint. Additionally, total pain interference as measured by the BPI will be transformed onto a 0-100 ( higher is less pain) point scale. The area under the curve (AUC) from baseline to week 4 was calculated for each patient's score. The average AUC for the placebo arm and the topical amitriptyline HCl/ baclofen/ ketamine arm are reported.
Time Frame Up to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baclofen-amitriptyline Hydrochloride-ketamine Placebo
Hide Arm/Group Description:
Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Baclofen/amitriptyline/ketamine gel: Applied topically.
Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Placebo: Applied topically
Overall Number of Participants Analyzed 101 102
Mean (Standard Deviation)
Unit of Measure: units on a scale * week
Worst Pain 58.1  (25.48) 58.7  (27.39)
Least Pain 78.0  (20.28) 77.3  (22.01)
Average Pain 66.4  (21.99) 65.4  (24.55)
BPI Total Interference 76.5  (20.16) 77.3  (21.16)
6.Secondary Outcome
Title Numbness, Tingling, and Pain as Measured by the Peripheral Neuropathy Questionnaire at Baseline and Weekly for 4 Weeks
Hide Description The Peripheral Neuropathy Questionnaire was used to analyze this endpoint. Patient neuropathy symptoms were scored on a 0 - 100 scale (higher score represents less symptomatic). The area under the curve (AUC) from baseline to week 4 was calculated for each patient's score. The average AUC for the placebo arm and the topical amitriptyline HCl/ baclofen/ ketamine arm are reported.
Time Frame Up to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baclofen-amitriptyline Hydrochloride-ketamine Placebo
Hide Arm/Group Description:
Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Baclofen/amitriptyline/ketamine gel: Applied topically.
Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Placebo: Applied topically
Overall Number of Participants Analyzed 101 102
Mean (Standard Deviation)
Unit of Measure: units on a scale * week
172.6  (82.09) 175.7  (85.38)
7.Secondary Outcome
Title Adverse Event Profile of Topical Amitriptyline HCl/ Baclofen/Ketamine > Frequency and Severity of Adverse Events Reported by the Patient in the > Symptom Experience Diary and Evaluated Through Clinical Assessment by NCI CTCAE v3.0
Hide Description Frequency and severity of adverse events reported by patients in weekly diary and evaluated through clinical assessment by NCI CTCAE v3.0. The number of patients reporting grade 3 or higher events are reported in this outcome measure. For a full list of all events, please refer to the Adverse Events section of this report.
Time Frame Up to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients that were assessed for adverse events are used in this analysis.
Arm/Group Title Baclofen-amitriptyline Hydrochloride-ketamine Placebo
Hide Arm/Group Description:
Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Baclofen/amitriptyline/ketamine gel: Applied topically.
Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Placebo: Applied topically
Overall Number of Participants Analyzed 101 102
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 3+ Adverse Event
8
   7.9%
5
   4.9%
Grade 4+ Adverse Event
1
   1.0%
1
   1.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Baclofen-amitriptyline Hydrochloride-ketamine Placebo
Hide Arm/Group Description Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Baclofen/amitriptyline/ketamine gel: Applied topically. Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Placebo: Applied topically
All-Cause Mortality
Baclofen-amitriptyline Hydrochloride-ketamine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Baclofen-amitriptyline Hydrochloride-ketamine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/101 (0.99%)      1/102 (0.98%)    
General disorders     
Disease progression  1  0/101 (0.00%)  0 1/102 (0.98%)  1
Vascular disorders     
Thrombosis  1  1/101 (0.99%)  1 0/102 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Baclofen-amitriptyline Hydrochloride-ketamine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   48/101 (47.52%)      45/102 (44.12%)    
Ear and labyrinth disorders     
Tinnitus  1  0/101 (0.00%)  0 1/102 (0.98%)  1
Gastrointestinal disorders     
Abdominal pain  1  0/101 (0.00%)  0 2/102 (1.96%)  5
Constipation  1  24/101 (23.76%)  62 28/102 (27.45%)  71
Diarrhea  1  1/101 (0.99%)  1 1/102 (0.98%)  1
Dry mouth  1  18/101 (17.82%)  55 23/102 (22.55%)  55
Ileal obstruction  1  0/101 (0.00%)  0 1/102 (0.98%)  1
Nausea  1  1/101 (0.99%)  1 0/102 (0.00%)  0
Small intestinal obstruction  1  0/101 (0.00%)  0 2/102 (1.96%)  4
Stomach pain  1  0/101 (0.00%)  0 0/102 (0.00%)  0
Vomiting  1  1/101 (0.99%)  1 0/102 (0.00%)  0
General disorders     
Edema limbs  1  1/101 (0.99%)  1 1/102 (0.98%)  1
Fatigue  1  1/101 (0.99%)  1 1/102 (0.98%)  1
Pain  1  0/101 (0.00%)  0 0/102 (0.00%)  0
Immune system disorders     
Hypersensitivity  1  0/101 (0.00%)  0 1/102 (0.98%)  1
Infections and infestations     
Bladder infection  1  0/101 (0.00%)  0 0/102 (0.00%)  0
Skin infection  1  1/101 (0.99%)  2 0/102 (0.00%)  0
Injury, poisoning and procedural complications     
Fracture  1  0/101 (0.00%)  0 0/102 (0.00%)  0
Investigations     
Alkaline phosphatase increased  1  0/101 (0.00%)  0 1/102 (0.98%)  1
Aspartate aminotransferase increased  1  0/101 (0.00%)  0 1/102 (0.98%)  1
Platelet count decreased  1  0/101 (0.00%)  0 1/102 (0.98%)  1
Musculoskeletal and connective tissue disorders     
Back pain  1  0/101 (0.00%)  0 0/102 (0.00%)  0
Chest wall pain  1  0/101 (0.00%)  0 0/102 (0.00%)  0
Joint pain  1  1/101 (0.99%)  1 0/102 (0.00%)  0
Pain in extremity  1  1/101 (0.99%)  1 0/102 (0.00%)  0
Nervous system disorders     
Ataxia  1  0/101 (0.00%)  0 1/102 (0.98%)  1
Depressed level of consciousness  1  2/101 (1.98%)  2 2/102 (1.96%)  2
Dizziness  1  0/101 (0.00%)  0 0/102 (0.00%)  0
Neuralgia  1  1/101 (0.99%)  1 0/102 (0.00%)  0
Peripheral sensory neuropathy  1  0/101 (0.00%)  0 2/102 (1.96%)  2
Syncope vasovagal  1  0/101 (0.00%)  0 0/102 (0.00%)  0
Psychiatric disorders     
Anxiety  1  0/101 (0.00%)  0 0/102 (0.00%)  0
Confusion  1  5/101 (4.95%)  5 4/102 (3.92%)  4
Skin and subcutaneous tissue disorders     
Dry skin  1  1/101 (0.99%)  1 0/102 (0.00%)  0
Hand-and-foot syndrome  1  16/101 (15.84%)  26 12/102 (11.76%)  25
Pruritus  1  0/101 (0.00%)  0 0/102 (0.00%)  0
Vascular disorders     
Thrombosis  1  0/101 (0.00%)  0 1/102 (0.98%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10
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: Debra Barton, R.N., Ph.D.
Organization: Mayo Clinic
EMail: Barton.debra@mayo.edu
Layout table for additonal information
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00516503     History of Changes
Other Study ID Numbers: NCCTG-N06CA
NCI-2011-01768 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
CDR0000560732 ( Registry Identifier: PDQ (Physician Data Query) )
First Submitted: August 14, 2007
First Posted: August 15, 2007
Results First Submitted: November 2, 2016
Results First Posted: August 24, 2017
Last Update Posted: August 24, 2017