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Rizatriptan 5 mg and 10 mg, Sumatriptan 100 mg, and Placebo Comparison Study (0462-030)

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: NCT00898677
Recruitment Status : Completed
First Posted : May 12, 2009
Results First Posted : July 14, 2009
Last Update Posted : March 4, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Migraine Headache
Interventions Drug: rizatriptan benzoate
Drug: Comparator: sumatriptan
Drug: Comparator: Placebo
Enrollment 1268
Recruitment Details

Patients were recruited at 47 sites in 21 countries in Canada, South America, Europe, Middle East, South Africa, and Australia

First Patient Treated: September 1995

Last Patient Treated: May 1996

Pre-assignment Details Outpatients screened at a pretreatment visit were given allocated drug supply with instructions. If patients had not treated an attack within 2 months of being enrolled, they were required to return for a rescreen visit. If by 4 months after being enrolled patients still had not treated an attack, they were discontinued from the study.
Arm/Group Title Rizatriptan 5 mg Rizatriptan 10 mg Sumatriptan 100 mg Placebo
Hide Arm/Group Description Rizatriptan 5 mg orally once for treatment of single migraine attack Rizatriptan 10 mg orally once for treatment of single migraine attack Sumatriptan 100 mg orally once for treatment of single migraine attack Placebo matching Rizatriptan and Sumatriptan orally once for treatment of single migraine attack
Period Title: Overall Study
Started 180 455 455 178
Patients Treated 164 [1] 387 [2] 388 [3] 160 [4]
Completed 163 386 383 159
Not Completed 17 69 72 19
Reason Not Completed
Adverse Event             0             0             1             0
Lost to Follow-up             0             0             2             0
Protocol Violation             1             1             2             0
Withdrawal by Subject             0             0             0             1
Not Treated: Adverse Event             0             2             1             0
Not Treated: Lost to Follow-Up             0             5             5             2
Not Treated: Pregnancy             0             0             1             0
Not Treated: Protocol Violation             2             0             2             0
Not Treated: Withdraw by Subject             2             16             11             3
Not Treated: Patient uncooperative             2             3             1             0
Not Treated: Abnormal Prestudy Labs             0             0             0             1
Not Treated: Abnormal Baseline ECG             1             0             0             0
Not Treated: No Longer Met Inc Criteria             0             3             1             0
Not Treated: Lack of Migraine Attack             9             39             43             12
Not Treated: Other (Not Specified)             0             0             2             0
[1]
Patients Not Treated: 16
[2]
Patients Not Treated: 68
[3]
Patients Not Treated: 67
[4]
Patients Not Treated: 18
Arm/Group Title Rizatriptan 5 mg Rizatriptan 10 mg Sumatriptan 100 mg Placebo Total
Hide Arm/Group Description

Rizatriptan 5 mg orally once for treatment of single migraine attack.

Baseline measure Participants reported are those participants that recieved study treatment.

Rizatriptan 10 mg orally once for treatment of single migraine attack

Baseline measure Participants reported are those participants that recieved study treatment.

Sumatriptan 100 mg orally once for treatment of single migraine attack

Baseline measure Participants reported are those participants that recieved study treatment.

Placebo matching Rizatriptan and Sumatriptan orally once for treatment of single migraine attack

Baseline measure Participants reported are those participants that recieved study treatment.

Total of all reporting groups
Overall Number of Baseline Participants 164 387 388 160 1099
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 164 participants 387 participants 388 participants 160 participants 1099 participants
38.3  (10.3) 37.0  (10.0) 39.2  (10.1) 38.3  (10.3) 38.2  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 164 participants 387 participants 388 participants 160 participants 1099 participants
Female
138
  84.1%
319
  82.4%
309
  79.6%
132
  82.5%
898
  81.7%
Male
26
  15.9%
68
  17.6%
79
  20.4%
28
  17.5%
201
  18.3%
Baseline Headache Severity   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 164 participants 387 participants 388 participants 160 participants 1099 participants
Grades 1, 0: Mild, no pain, or missing 0 0 1 1 2
Grade 2: Moderate 72 174 191 75 512
Grade 3: Severe 92 213 196 84 585
[1]
Measure Description: Each patient rated headache severity on a 4-grade scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain).
Race/Ethnicity  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 164 participants 387 participants 388 participants 160 participants 1099 participants
Caucasian 117 282 281 120 800
Black 1 5 3 0 9
Asian 0 1 2 0 3
Hispanic 33 80 77 32 222
Mestizo 9 15 22 7 53
Mexican 0 2 2 0 4
Colored 0 0 1 0 1
Mexican/Hispanic 1 0 0 0 1
Mixed 2 2 0 1 5
Asian/Caucasian 1 0 0 0 1
1.Primary Outcome
Title Pain Relief at 2 Hours After Dose
Hide Description Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe pain) at baseline to grades 0 or 1 (no headache or mild pain) at 2 hours after treatment
Time Frame 2 hours after dose
Hide Outcome Measure Data
Hide Analysis Population Description
An “all-patients-treated” approach was used in the primary analysis, including all patients who had at least one assessment of pain severity within 2 hours after test medication. Missing values in the treatment phase (i.e., after the baseline phase) were imputed by carrying forward the preceding values in the same phase.
Arm/Group Title Rizatriptan 5 mg Rizatriptan 10 mg Sumatriptan 100 mg Placebo
Hide Arm/Group Description:
Rizatriptan 5 mg orally once for treatment of single migraine attack
Rizatriptan 10 mg orally once for treatment of single migraine attack
Sumatriptan 100 mg orally once for treatment of single migraine attack
Placebo matching Rizatriptan and Sumatriptan orally once for treatment of single migraine attack
Overall Number of Participants Analyzed 164 385 387 159
Measure Type: Number
Unit of Measure: Participants
2-hour pain relief 99 258 239 64
No 2-hour pain relief 65 127 148 95
2.Primary Outcome
Title Time to Relief Within 2 Hours After Dose
Hide Description Patients reporting time to relief defined as the first time point at which a patient reported headache severity grade 1 or 0 (mild pain or no headache) within 2 hours after dose
Time Frame within 2 hours after dose
Hide Outcome Measure Data
Hide Analysis Population Description
An “all-patients-treated” approach was used in the primary analysis, including all patients who had at least one assessment of pain severity within 2 hours after test medication.
Arm/Group Title Rizatriptan 5 mg Rizatriptan 10 mg Sumatriptan 100 mg Placebo
Hide Arm/Group Description:
Rizatriptan 5 mg orally once for treatment of single migraine attack
Rizatriptan 10 mg orally once for treatment of single migraine attack
Sumatriptan 100 mg orally once for treatment of single migraine attack
Placebo matching Rizatriptan and Sumatriptan orally once for treatment of single migraine attack
Overall Number of Participants Analyzed 164 385 387 159
Measure Type: Number
Unit of Measure: Participants
First pain relief within 2 hrs 102 265 247 72
Pain relief did not occur within 2 hrs 62 120 140 87
3.Secondary Outcome
Title Pain Free at 2 Hours After Dose
Hide Description Patients pain free (defined as a reduction of headache severity to grade 0 [no pain]) at 2 hours after treatment. Each patient rated headache severity on a 4-point scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain).
Time Frame 2 hours after dose
Hide Outcome Measure Data
Hide Analysis Population Description
An “all-patients-treated” approach was used in the secondary analysis, including all patients who had at least one assessment of pain severity within 2 hours after test medication. Missing values in the treatment phase (i.e., after the baseline phase) were imputed by carrying forward the preceding values in the same phase.
Arm/Group Title Rizatriptan 5 mg Rizatriptan 10 mg Sumatriptan 100 mg Placebo
Hide Arm/Group Description:
Rizatriptan 5 mg orally once for treatment of single migraine attack
Rizatriptan 10 mg orally once for treatment of single migraine attack
Sumatriptan 100 mg orally once for treatment of single migraine attack
Placebo matching Rizatriptan and Sumatriptan orally once for treatment of single migraine attack
Overall Number of Participants Analyzed 164 385 387 159
Measure Type: Number
Unit of Measure: Participants
2-hour Pain freedom 41 155 127 15
No 2-hour pain freedom 123 230 260 139
4.Secondary Outcome
Title Functional Status at 2 Hours After Dose
Hide Description Patients with no functional disability measured by the level of impairment to daily activities at 2 hours after treatment. Each patient rated functional disability on a 4-grade scale (0 = no functional disability; 1 = daily activities mildly impaired; 2 = daily activities severely impaired; 3 = unable to carry out daily activities, requires bed rest).
Time Frame 2 hours after dose
Hide Outcome Measure Data
Hide Analysis Population Description
An “all-patients-treated” approach was used in the secondary analysis. Missing data were replaced by carrying forward the preceding value.
Arm/Group Title Rizatriptan 5 mg Rizatriptan 10 mg Sumatriptan 100 mg Placebo
Hide Arm/Group Description:
Rizatriptan 5 mg orally once for treatment of single migraine attack
Rizatriptan 10 mg orally once for treatment of single migraine attack
Sumatriptan 100 mg orally once for treatment of single migraine attack
Placebo matching Rizatriptan and Sumatriptan orally once for treatment of single migraine attack
Overall Number of Participants Analyzed 164 385 387 159
Measure Type: Number
Unit of Measure: Participants
No functional disability 52 160 126 31
Mildly impaired 62 123 142 59
Severely impaired 27 60 67 33
Required bed rest 23 42 52 36
5.Secondary Outcome
Title Nausea at 2 Hours After Dose
Hide Description Patients who recorded the presence or absence of nausea 2 hours after dose
Time Frame 2 hours after dose
Hide Outcome Measure Data
Hide Analysis Population Description
An “all-patients-treated” approach was used in the secondary analysis. Missing data were replaced by carrying forward the preceding value.
Arm/Group Title Rizatriptan 5 mg Rizatriptan 10 mg Sumatriptan 100 mg Placebo
Hide Arm/Group Description:
Rizatriptan 5 mg orally once for treatment of single migraine attack
Rizatriptan 10 mg orally once for treatment of single migraine attack
Sumatriptan 100 mg orally once for treatment of single migraine attack
Placebo matching Rizatriptan and Sumatriptan orally once for treatment of single migraine attack
Overall Number of Participants Analyzed 164 385 387 159
Measure Type: Number
Unit of Measure: participants
2-hour Nausea 37 95 128 68
No 2-hour Nausea 127 290 259 91
Time Frame During the 24 hours treatment period, and up to and including 7 days after the last dose of study therapy.
Adverse Event Reporting Description

Although a patient may have had two or more adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.

Adverse Event participants reported are those participants that received study treatment and had safety follow-up.

 
Arm/Group Title Rizatriptan 5 mg Rizatriptan 10 mg Sumatriptan 100 mg Placebo
Hide Arm/Group Description Rizatriptan 5 mg orally once for treatment of single migraine attack Rizatriptan 10 mg orally once for treatment of single migraine attack Sumatriptan 100 mg orally once for treatment of single migraine attack Placebo matching Rizatriptan and Sumatriptan orally once for treatment of single migraine attack
All-Cause Mortality
Rizatriptan 5 mg Rizatriptan 10 mg Sumatriptan 100 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Rizatriptan 5 mg Rizatriptan 10 mg Sumatriptan 100 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/164 (0.61%)   0/387 (0.00%)   0/388 (0.00%)   0/160 (0.00%) 
Reproductive system and breast disorders         
Endometriosis * 1  1/164 (0.61%)  0/387 (0.00%)  0/388 (0.00%)  0/160 (0.00%) 
*
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 1%
Rizatriptan 5 mg Rizatriptan 10 mg Sumatriptan 100 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   62/164 (37.80%)   159/387 (41.09%)   188/388 (48.45%)   51/160 (31.87%) 
Cardiac disorders         
Palpitation * 1  7/164 (4.27%)  6/387 (1.55%)  2/388 (0.52%)  0/160 (0.00%) 
Tachycardia * 1  1/164 (0.61%)  3/387 (0.78%)  7/388 (1.80%)  2/160 (1.25%) 
Eye disorders         
Blurred Vision * 1  0/164 (0.00%)  3/387 (0.78%)  5/388 (1.29%)  0/160 (0.00%) 
Gastrointestinal disorders         
Acid Regurgitation * 1  2/164 (1.22%)  1/387 (0.26%)  1/388 (0.26%)  2/160 (1.25%) 
Diarrhea * 1  1/164 (0.61%)  5/387 (1.29%)  3/388 (0.77%)  1/160 (0.63%) 
Dry Mouth * 1  4/164 (2.44%)  9/387 (2.33%)  7/388 (1.80%)  2/160 (1.25%) 
Dyspepsia * 1  0/164 (0.00%)  2/387 (0.52%)  6/388 (1.55%)  1/160 (0.63%) 
Nausea * 1  8/164 (4.88%)  22/387 (5.68%)  35/388 (9.02%)  4/160 (2.50%) 
Vomiting * 1  5/164 (3.05%)  12/387 (3.10%)  10/388 (2.58%)  8/160 (5.00%) 
Perversion, Taste * 1  0/164 (0.00%)  1/387 (0.26%)  4/388 (1.03%)  0/160 (0.00%) 
General disorders         
Asthenia/Fatigue * 1  4/164 (2.44%)  30/387 (7.75%)  32/388 (8.25%)  6/160 (3.75%) 
Chills * 1  3/164 (1.83%)  3/387 (0.78%)  6/388 (1.55%)  1/160 (0.63%) 
Cold Sensation * 1  2/164 (1.22%)  4/387 (1.03%)  4/388 (1.03%)  4/160 (2.50%) 
Fever * 1  1/164 (0.61%)  2/387 (0.52%)  2/388 (0.52%)  2/160 (1.25%) 
Pain, Abdominal * 1  7/164 (4.27%)  12/387 (3.10%)  20/388 (5.15%)  2/160 (1.25%) 
Pain, Chest * 1  2/164 (1.22%)  13/387 (3.36%)  22/388 (5.67%)  4/160 (2.50%) 
Warm Sensation * 1  2/164 (1.22%)  2/387 (0.52%)  0/388 (0.00%)  1/160 (0.63%) 
Metabolism and nutrition disorders         
Alkaline Phosphatase Increased * 1  0/164 (0.00%)  0/387 (0.00%)  1/388 (0.26%)  2/160 (1.25%) 
Alanine Aminotransferase Increased * 1  2/164 (1.22%)  2/387 (0.52%)  3/388 (0.77%)  1/160 (0.63%) 
Aspartate Aminotransferase Increased * 1  3/164 (1.83%)  1/387 (0.26%)  5/388 (1.29%)  1/160 (0.63%) 
Hypokalemia * 1  2/164 (1.22%)  0/387 (0.00%)  0/388 (0.00%)  0/160 (0.00%) 
Musculoskeletal and connective tissue disorders         
Heaviness, Regional * 1  1/164 (0.61%)  10/387 (2.58%)  9/388 (2.32%)  0/160 (0.00%) 
Myalgia * 1  0/164 (0.00%)  1/387 (0.26%)  5/388 (1.29%)  0/160 (0.00%) 
Pain, Neck * 1  1/164 (0.61%)  4/387 (1.03%)  4/388 (1.03%)  2/160 (1.25%) 
Pain, Shoulder * 1  0/164 (0.00%)  4/387 (1.03%)  0/388 (0.00%)  0/160 (0.00%) 
Stiffness * 1  0/164 (0.00%)  1/387 (0.26%)  4/388 (1.03%)  0/160 (0.00%) 
Nervous system disorders         
Dizziness * 1  9/164 (5.49%)  30/387 (7.75%)  35/388 (9.02%)  6/160 (3.75%) 
Headache * 1  3/164 (1.83%)  12/387 (3.10%)  11/388 (2.84%)  2/160 (1.25%) 
Hypesthesia * 1  1/164 (0.61%)  2/387 (0.52%)  9/388 (2.32%)  0/160 (0.00%) 
Paresthesia * 1  3/164 (1.83%)  11/387 (2.84%)  16/388 (4.12%)  5/160 (3.13%) 
Tremor * 1  4/164 (2.44%)  1/387 (0.26%)  8/388 (2.06%)  1/160 (0.63%) 
Psychiatric disorders         
Anxiety * 1  2/164 (1.22%)  2/387 (0.52%)  9/388 (2.32%)  1/160 (0.63%) 
Depression * 1  3/164 (1.83%)  0/387 (0.00%)  3/388 (0.77%)  0/160 (0.00%) 
Insomnia * 1  2/164 (1.22%)  0/387 (0.00%)  6/388 (1.55%)  2/160 (1.25%) 
Nervousness * 1  1/164 (0.61%)  1/387 (0.26%)  4/388 (1.03%)  0/160 (0.00%) 
Somnolence * 1  13/164 (7.93%)  32/387 (8.27%)  28/388 (7.22%)  9/160 (5.63%) 
Renal and urinary disorders         
Urinary Frequency * 1  0/164 (0.00%)  0/387 (0.00%)  1/388 (0.26%)  2/160 (1.25%) 
Reproductive system and breast disorders         
Hot Flashes * 1  1/164 (0.61%)  4/387 (1.03%)  8/388 (2.06%)  2/160 (1.25%) 
Respiratory, thoracic and mediastinal disorders         
Discomfort, Pharyngeal * 1  1/164 (0.61%)  4/387 (1.03%)  11/388 (2.84%)  0/160 (0.00%) 
Dyspnea * 1  2/164 (1.22%)  4/387 (1.03%)  4/388 (1.03%)  0/160 (0.00%) 
Pharyngitis * 1  1/164 (0.61%)  4/387 (1.03%)  4/388 (1.03%)  1/160 (0.63%) 
Skin and subcutaneous tissue disorders         
Flushing * 1  0/164 (0.00%)  2/387 (0.52%)  4/388 (1.03%)  1/160 (0.63%) 
Sweating * 1  1/164 (0.61%)  5/387 (1.29%)  10/388 (2.58%)  1/160 (0.63%) 
*
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 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.
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00898677     History of Changes
Other Study ID Numbers: 0462-030
2009_591
First Submitted: May 8, 2009
First Posted: May 12, 2009
Results First Submitted: May 21, 2009
Results First Posted: July 14, 2009
Last Update Posted: March 4, 2015