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Trial record 82 of 434 for:    KETOROLAC

Efficacy and Safety of Intranasal Ketorolac for the Acute Treatment of Migraine

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ClinicalTrials.gov Identifier: NCT00483717
Recruitment Status : Completed
First Posted : June 7, 2007
Results First Posted : September 30, 2016
Last Update Posted : September 30, 2016
Sponsor:
Information provided by (Responsible Party):
Egalet Ltd

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Migraine
Interventions Drug: Ketorolac tromethamine
Drug: Placebo
Enrollment 173
Recruitment Details 5 months and 3 weeks; Medical Centers and Hospitals
Pre-assignment Details  
Arm/Group Title Ketorolac Tromethamine Placebo
Hide Arm/Group Description

Intranasal ketorolac tromethamine

Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)

Intranasal Placebo

Placebo : Intranasal (IN) placebo

Period Title: Overall Study
Started 87 86
Completed 63 65
Not Completed 24 21
Reason Not Completed
Protocol Violation             5             7
Time of dosing missing             1             1
No treatment for migraine             16             13
Lost to Follow-up             1             0
Withdrawal by Subject             1             0
Arm/Group Title Ketorolac Tromethamine Placebo Total
Hide Arm/Group Description

Intranasal ketorolac tromethamine

Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)

Intranasal Placebo

Placebo : Intranasal (IN) placebo

Total of all reporting groups
Overall Number of Baseline Participants 87 86 173
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 86 participants 173 participants
<=18 years
0
   0.0%
2
   2.3%
2
   1.2%
Between 18 and 65 years
87
 100.0%
84
  97.7%
171
  98.8%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 87 participants 86 participants 173 participants
38.2  (11.4) 38.5  (11.6) 38.3  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 86 participants 173 participants
Female
82
  94.3%
76
  88.4%
158
  91.3%
Male
5
   5.7%
10
  11.6%
15
   8.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 87 participants 86 participants 173 participants
Germany 50 48 98
Finland 37 38 75
1.Primary Outcome
Title The Number of Treated Subjects Who Became Pain-free (International Headache Society Grade of 0 = no Pain) by Observation Time Point.
Hide Description Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain
Time Frame 2 hours after dosing
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified ITT
Arm/Group Title Ketorolac Tromethamine Placebo
Hide Arm/Group Description:

Intranasal ketorolac tromethamine

Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)

Intranasal Placebo

Placebo : Intranasal (IN) placebo

Overall Number of Participants Analyzed 68 72
Measure Type: Number
Unit of Measure: participants
12 7
2.Secondary Outcome
Title The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point
Hide Description Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain
Time Frame 0.5 hours post-dosing
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified ITT
Arm/Group Title Ketorolac Tromethamine Placebo
Hide Arm/Group Description:

Intranasal ketorolac tromethamine

Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)

Intranasal Placebo

Placebo : Intranasal (IN) placebo

Overall Number of Participants Analyzed 68 72
Measure Type: Number
Unit of Measure: participants
2 1
3.Secondary Outcome
Title The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point
Hide Description Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain
Time Frame 1 hour post-dosing
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified ITT
Arm/Group Title Ketorolac Tromethamine Placebo
Hide Arm/Group Description:

Intranasal ketorolac tromethamine

Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)

Intranasal Placebo

Placebo : Intranasal (IN) placebo

Overall Number of Participants Analyzed 68 72
Measure Type: Number
Unit of Measure: participants
12 4
4.Secondary Outcome
Title The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point
Hide Description Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain
Time Frame 1.5 hours post-dosing
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified ITT
Arm/Group Title Ketorolac Tromethamine Placebo
Hide Arm/Group Description:

Intranasal ketorolac tromethamine

Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)

Intranasal Placebo

Placebo : Intranasal (IN) placebo

Overall Number of Participants Analyzed 68 72
Measure Type: Number
Unit of Measure: participants
19 6
5.Secondary Outcome
Title The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point
Hide Description Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain
Time Frame 3 hours post-dosing
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified ITT
Arm/Group Title Ketorolac Tromethamine Placebo
Hide Arm/Group Description:

Intranasal ketorolac tromethamine

Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)

Intranasal Placebo

Placebo : Intranasal (IN) placebo

Overall Number of Participants Analyzed 67 72
Measure Type: Number
Unit of Measure: participants
22 10
6.Secondary Outcome
Title The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point
Hide Description Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain
Time Frame 4 hours post-dosing
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified ITT
Arm/Group Title Ketorolac Tromethamine Placebo
Hide Arm/Group Description:

Intranasal ketorolac tromethamine

Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)

Intranasal Placebo

Placebo : Intranasal (IN) placebo

Overall Number of Participants Analyzed 67 72
Measure Type: Number
Unit of Measure: participants
25 11
7.Secondary Outcome
Title The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point
Hide Description Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain
Time Frame 24 hours post-dosing
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified ITT
Arm/Group Title Ketorolac Tromethamine Placebo
Hide Arm/Group Description:

Intranasal ketorolac tromethamine

Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)

Intranasal Placebo

Placebo : Intranasal (IN) placebo

Overall Number of Participants Analyzed 67 72
Measure Type: Number
Unit of Measure: participants
37 18
8.Secondary Outcome
Title The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point
Hide Description Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain
Time Frame 48 hours post-dosing
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified ITT
Arm/Group Title Ketorolac Tromethamine Placebo
Hide Arm/Group Description:

Intranasal ketorolac tromethamine

Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)

Intranasal Placebo

Placebo : Intranasal (IN) placebo

Overall Number of Participants Analyzed 67 72
Measure Type: Number
Unit of Measure: participants
33 15
Time Frame 5 months and 3 weeks
Adverse Event Reporting Description ITT population
 
Arm/Group Title Ketorolac Tromethamine Placebo
Hide Arm/Group Description

Intranasal ketorolac tromethamine

Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)

Intranasal Placebo

Placebo : Intranasal (IN) placebo

All-Cause Mortality
Ketorolac Tromethamine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ketorolac Tromethamine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/69 (1.45%)      0/73 (0.00%)    
Nervous system disorders     
Hypoaesthesia * 1  1/69 (1.45%)  2 0/73 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ketorolac Tromethamine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   53/69 (76.81%)      40/73 (54.79%)    
Gastrointestinal disorders     
Hypoaesthesia oral * 1  5/69 (7.25%)  5 5/73 (6.85%)  5
General disorders     
Fatigue * 1  4/69 (5.80%)  4 3/73 (4.11%)  3
Nervous system disorders     
Dizziness * 1  4/69 (5.80%)  4 3/73 (4.11%)  3
Dysgeusia * 1  1/69 (1.45%)  1 4/73 (5.48%)  4
Respiratory, thoracic and mediastinal disorders     
Intranasal hypoaesthesia * 1  5/69 (7.25%)  5 14/73 (19.18%)  14
Nasal congestion * 1  9/69 (13.04%)  9 3/73 (4.11%)  3
Nasal discomfort * 1  17/69 (24.64%)  17 2/73 (2.74%)  2
Pharyngeal hypoaesthesia * 1  1/69 (1.45%)  1 6/73 (8.22%)  6
Rhinalgia * 1  7/69 (10.14%)  7 0/73 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: David Bregman, M.D., Ph.D
Organization: Luitpold Pharmaceuticals, Inc.
Phone: 601-650-4200 ext 828
Responsible Party: Egalet Ltd
ClinicalTrials.gov Identifier: NCT00483717     History of Changes
Other Study ID Numbers: ROX-2007-01
First Submitted: June 5, 2007
First Posted: June 7, 2007
Results First Submitted: August 31, 2012
Results First Posted: September 30, 2016
Last Update Posted: September 30, 2016