- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02912650
A Safety And Efficacy Study of Ibuprofen 250 mg / Acetaminophen 500 mg In The Treatment Of Post-Surgical Dental Pain (SDDP)
July 28, 2017 updated by: Pfizer
A Phase 3, Double-Blind, Randomized, Safety And Efficacy Study Comparing A Single Oral Dose Of Ibuprofen (IBU) 250 Mg/Acetaminophen (APAP) 500 Mg (Administered As Two Tablets Of IBU/APAP 125 Mg/250 Mg) To Each Active Drug Monocomponent Alone And To Placebo In The Treatment Of Post-Surgical Dental Pain
This is a randomized, double blind, placebo-controlled, parallel group, single-center study in approximately 560 subjects to determine the overall analgesic efficacy and safety of a fixed-dose ibuprofen 250 mg / acetaminophen 500 mg formulation compared to ibuprofen 250 mg alone, acetaminophen 650 mg alone, and to placebo.
Subjects will be healthy males and females aged 18-40 years, inclusive, who are experiencing post-operative pain following surgical extraction of 3 or more third molar teeth.
Following extraction, subjects must experience, within 5 hours, post-surgical pain of at least moderate severity (on a 4-point categorical scale), confirmed by a Visual Analog Pain Severity Rating Scale (VAS PSR) of at least 50 mm on a 100 mm VAS PSR scale.
Eligible subjects will be randomized to receive a single oral dose of study medication under double-blind conditions and then evaluated on site for 12 hours following administration of study medication.
Subjects will provide self-ratings of pain severity and pain relief at various time points using categorical and numerical scales.
Additionally, subjects will also evaluate the time to first perceptible relief and time to meaningful relief using a double stopwatch method.
Finally, at 12 hours, subjects will complete a categorical Global Evaluation of the study medication.
A review of any reported adverse events will also be completed.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
This is a 12-hour, 4-arm, randomized, double blind, placebo-controlled, parallel group, single-center study in approximately 560 subjects to determine the overall analgesic efficacy and safety of a fixed-dose ibuprofen 250 mg / acetaminophen 500 mg formulation (administered as two caplets of 125 mg/250 mg IBU/APAP) compared to ibuprofen 250 mg alone, acetaminophen 650 mg alone, and to placebo.
Subjects will be healthy males and females aged 18-40 years, inclusive, otherwise healthy, who are experiencing post-operative pain following surgical extraction of 3 or more third molar teeth.
Following extraction, subjects must experience, within 5 hours, post-surgical pain of at least moderate severity (on a 4-point categorical scale), confirmed by a Visual Analog Pain Severity Rating Scale (VAS PSR) of at least 50 mm on a 100 mm VAS PSR scale.
Upon completion of the baseline scales, eligible subjects will be randomized to receive a single oral dose of study medication under double-blind conditions and then evaluated on site for 12 hours following administration of study medication.
At 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post dose time points, subjects will provide: self-ratings of pain severity using the numerical and categorical PSRs; and self-ratings of pain relief at each time point using a categorical pain relief rating scale.
At 12 hours, subjects will also complete a 6-point categorical Global Evaluation of the study medication.
Additionally, subjects will also evaluate the time to first perceptible relief and time to meaningful relief using a double stopwatch method up to 12 hours post-dose or until the time of first rescue medication use, whichever is sooner.
A review of any reported adverse events will also be completed.
Study Type
Interventional
Enrollment (Actual)
568
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Utah
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Salt Lake City, Utah, United States, 84124
- Jean Brown Research
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 38 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Outpatients who have undergone surgical extraction of 3 or more third molars, of which at least 2 must be a partial or complete bony mandibular impaction.
- Subject must have at least moderate pain on the 4-point categorical scale, confirmed by at least 50 mm on the 100 mm VAS PSR scale within approximately 5 hours (i.e., less than or equal to 5 hours, 15 minutes) after surgery is completed.
- Female subjects are not pregnant or breast feeding.
- Informed consent.
Exclusion Criteria:
- Presence or history of any significant hepatic, renal, endocrine, cardiovascular, neurological, psychiatric, gastrointestinal, pulmonary, hematologic, or metabolic disorder determined by the Investigator to place the subject at increased risk, including the presence or history within 2 years of screening.
- Acute localized dental alveolar infection at the time of surgery that could confound the post-surgical evaluation.
- Hypersensitivity to ibuprofen, naproxen, aspirin, or any other NSAID; or to APAP, tramadol, other opioids, or to their combinations.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ibuprofen 250 mg / Acetaminophen 500 mg
2 caplets of Ibuprofen 125 mg / Acetaminophen 250 mg
|
2 caplets of Ibuprofen 250 mg / Acetaminophen 500 mg
Other Names:
|
Active Comparator: Ibuprofen 250 mg
2 caplets of IBU 125 mg
|
2 caplets of Ibuprofen 125 mg
Other Names:
|
Active Comparator: Acetaminophen 650 mg
2 tablets of APAP 325 mg
|
2 tablets of Acetaminophen 325 mg
Other Names:
|
Active Comparator: Placebo
2 caplets of Placebo
|
2 caplets of Placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale From 0 to 8 Hours Post-dose (SPID11 [0-8])
Time Frame: 0 to 8 hours post-dose
|
Pain intensity was assessed on an 11-point numerical pain severity rating scale.
SPID11 (0-8): Time-weighted sum of pain intensity difference (PID) scores over 8 hours.
SPID11 score range was -40 (worst score) to 80 (best score) for SPID 0-8.
PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study).
Total possible score range for PID: -5 (worst score) to 10 (best score).
|
0 to 8 hours post-dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale From 6 to 8 Hours Post-dose (SPID11 [6-8])
Time Frame: 6 to 8 hours post-dose
|
Pain intensity was assessed on an 11-point numerical pain severity rating scale.
SPID11 (6-8): Time-weighted sum of PID scores over 6 to 8 hours.
SPID11 score range was -15 (worst score) to 30 (best score) for SPID 6-8.
PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study).
Total possible score range for PID: -5 (worst score) to 10 (best score).
|
6 to 8 hours post-dose
|
Time-weighted Sum of Pain Relief Rating (TOTPAR) From 0 to 8 Hours and 6 to 8 Hours Post-dose
Time Frame: 0 to 8 hours, 6 to 8 hours post-dose
|
TOTPAR: Time-weighted sum of Pain Relief Rating (PRR) scores over 0 to 8 and 6 to 8 hours.
TOTPAR total score range: 0 (worst score) to 32 (best score) for TOTPAR 0-8 and 0 (worst score) to 12 (best score) for TOTPAR 6-8 hours.
PRR was assessed on a 5-point categorical pain relief rating scale which ranges from 0 =no relief to 4 =complete relief.
|
0 to 8 hours, 6 to 8 hours post-dose
|
Time to Treatment Failure
Time Frame: 0 to 12 hours post-dose
|
Time to treatment failure was defined as the time interval from the study drug administration up to the first documentation of treatment failure.
Treatment failure was defined as taking the rescue medication or discontinuation of the participants from the study due to lack of efficacy, whichever came first.
Participants were censored at 12 hours or at their final assessment time, whichever came first.
|
0 to 12 hours post-dose
|
Cumulative Percentage of Participants With Treatment Failure at 6 and 8 Hours
Time Frame: 6 hours, 8 hours post-dose
|
Treatment failure was defined as taking the rescue medication or discontinuation of the participants from the study due to lack of efficacy, whichever came first.
Participants were censored at 12 hours or at their final assessment time, whichever came first.
Percentage of participants who had treatment failure were reported.
|
6 hours, 8 hours post-dose
|
Time to Onset of Meaningful Pain Relief
Time Frame: 0 to 12 hours post-dose
|
Participants evaluated time to meaningful relief by stopping a second stopwatch labelled as "meaningful relief" at the moment they first began to experience meaningful relief.
Stopwatch was active up to 12 hours after dosing or until stopped by participant, or participant became treatment failure prior to depressing the second stopwatch.
Treatment failure was defined as participant taking rescue medication, or discontinuing due to lack of efficacy.
|
0 to 12 hours post-dose
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Confirmed Onset of First Perceptible Relief
Time Frame: 0 to 12 hours post-dose
|
Participants evaluated the time to first perceptible relief (confirmed by meaningful relief) by stopping the first stopwatch labeled 'first perceptible relief' at the moment they first began to experience any pain relief, if the participant also achieved meaningful relief by the end of the study.
Stopwatch was active up to 12 hours after dosing or until stopped by the participant, or until the participant dropped out due to treatment failure prior to depressing the first stopwatch or until the time of withdrawal (discontinuation).
Treatment failure was defined as participant taking rescue medication, or discontinuing due to lack of efficacy.
|
0 to 12 hours post-dose
|
Pain Relief Rating (PRR) Score
Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose
|
Participants answered a question: "how much relief do you have from your starting pain?" on a 5-point categorical pain relief rating scale.
Scale ranges from 0= no relief to 4= complete relief.
|
0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose
|
Pain Intensity Difference on 11-Point Numerical Scale (PID11)
Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose
|
PID11: baseline pain severity score minus pain severity score at a given time point.
Pain intensity was assessed on an 11-point numerical pain severity rating scale.
PID11 was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study).
Total possible score range for PID11: -5 (worst score) to 10 (best score).
|
0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose
|
Pain Intensity Difference on 4-Point Categorical Scale (PID4)
Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose
|
PID4: baseline pain severity score minus pain severity score at a given time point.
Pain intensity was assessed on a 4-point categorical pain severity rating scale.
PID4 was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 [no pain] to 3 [worst possible pain]) from the baseline pain intensity scores (score range: 2 =moderate pain to 3 =worst possible pain; as participants with baseline pain score of at least moderate were included in study).
Total possible score range for PID4: -1 (worst score) to 3 (best score).
|
0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose
|
Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4)
Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose
|
PRID4: sum of PID and PRR at each post-dose time points up to 12 hours.
Score range for PRID: -1(worst score) to 7(best score).
PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 [no pain] to 3 [worst possible pain]) from the baseline pain intensity scores (score range: 2 =moderate pain to 3 =worst possible pain; as participants with baseline pain score of at least moderate were included in study).
Total possible score range for PID4: -1 (worst score) to 3 (best score).
PRR was assessed on a 5-point categorical pain relief rating scale which ranges from 0 =no relief to 4 =complete relief.
|
0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose
|
Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale (SPID11) From 0 to 2 Hours, 0 to 6 Hours and 0 to 12 Hours Post-dose
Time Frame: 0 to 2 hours, 0 to 6 hours, 0 to 12 hours post-dose
|
Pain intensity was assessed on an 11-point numerical pain severity rating scale.
SPID11: Time-weighted sum of PID scores over 12 hours.
SPID11 score range was -10 (worst score) to 20 (best score) for SPID 0-2, -30 (worst score) to 60 (best score) for SPID 0-6, -60 (worst score) to 120 (best score) for SPID 0-12.
PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study).
Total possible score range for PID: -5 (worst) to 10 (best).
|
0 to 2 hours, 0 to 6 hours, 0 to 12 hours post-dose
|
Time-weighted Sum of Pain Intensity Difference Scores on 4-Point Categorical Scale (SPID4) From 0 to 2 Hours, 0 to 6 Hours, 0 to 8 Hours, 0 to 12 Hours and 6 to 8 Hours Post-dose
Time Frame: 0 to 2 hours, 0 to 6 hours, 0 to 8 hours, 0 to 12, 6 to 8 hours post-dose
|
Pain intensity was assessed on a 4-point categorical pain severity rating scale.
SPID4: Time-weighted sum of PID over post-dose time points.
SPID4 score range was -2 (worst score) to 6 (best score) for SPID 0-2, -6 (worst score) to 18 (best score) for SPID 0-6, -8 (worst score) to 24 (best score) for SPID 0-8, -12 (worst score) to 36 (best score) for SPID 0-12 and -3 (worst score) to 9 (best score) for SPID 6-8.
PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 [none] to 3 [severe]) from the baseline pain intensity scores (score range: 2 =moderate pain to 3 = severe pain; as participants with baseline pain score of at least moderate were included in study).
Total possible score range for PID: -1 (worst score) to 3 (best score).
|
0 to 2 hours, 0 to 6 hours, 0 to 8 hours, 0 to 12, 6 to 8 hours post-dose
|
Time-weighted Sum of Pain Relief Rating (TOTPAR) From 0 to 2 Hours, 0 to 6 Hours and 0 to 12 Hours Post Dose
Time Frame: 0 to 2 hours, 0 to 6 hours, 0 to 12 hours post-dose
|
TOTPAR: Time-weighted sum of PRR scores over 2, 6 and 12 hours.
TOTPAR total score range: 0 (worst score) to 8 (best score) for TOTPAR 0-2, 0 (worst score) to 24 (best score) for TOTPAR 0-6, 0 (worst score) to 32 (best score) for TOTPAR 0-8, 0 (worst score) to 48 (best score) for TOTPAR 0-12.
PRR was assessed on a 5-point categorical pain relief rating scale which ranges from 0 =no relief to 4 =complete relief.
|
0 to 2 hours, 0 to 6 hours, 0 to 12 hours post-dose
|
Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores on 4-Point Categorical Scale (SPRID4) Over 2, 6, 8, 12 and 6 to 8 Hours Post-dose
Time Frame: 0 to 2 hours, 0 to 6 hours, 0 to 8 hours, 0 to 12, 6 to 8 hours post-dose
|
SPRID4: Time-weighted sum of PRR and PID based on 4 point categorical pain severity rating scale (PRID) with score range: -2(worst score) to 14 (best score) for SPRID 0-2, -6 (worst score) to 42 (best score) for SPRID 0-6, -8 (worst score) to 56 (best score) for SPRID 0-8, -12 (worst score) to 84 (best score) for SPRID 0-12 and -3 (worst score) to 21 (best score) for SPRID 6-8 hours.
PRID: sum of PID and PRR at post-dose time point with score range: -1 (worst score) to 7 (best score).
PID calculated by subtracting pain intensity score at post-dose time points (score range: 0 [none] to 3 [severe]) from baseline pain intensity scores (score range: 2 =moderate pain to 3 = severe pain; as participants with baseline score of at least moderate were included).
PID total possible score range: -1 (worst score) to 3(best score).
PRR assessed on 5-point categorical scale with range: 0 =no relief to 4 =complete relief.
|
0 to 2 hours, 0 to 6 hours, 0 to 8 hours, 0 to 12, 6 to 8 hours post-dose
|
Cumulative Percentage of Participants With Treatment Failure
Time Frame: 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose
|
Treatment failure was defined as taking the rescue medication or discontinuation of the participants from the study due to lack of efficacy, whichever came first.
Participants were censored at 12 hours or at their final assessment time, whichever came first.
Percentage of participants who had treatment failure were reported.
|
1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose
|
Cumulative Percentage of Participants With Confirmed First Perceptible Relief
Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose
|
Percentage of participants with confirmed first perceptible relief was reported.
Participants evaluated the time to first perceptible relief (confirmed by meaningful relief) by stopping the first stopwatch labelled 'first perceptible relief' at the moment they first began to experience any pain relief, if the participant also achieved meaningful relief by the end of the study.
Stopwatch was active up to 12 hours after dosing or until stopped by the participant, or until the participant dropped out due to treatment failure prior to depressing the first stopwatch or until the time of withdrawal (discontinuation).
Treatment failure was defined as participant taking rescue medication, or discontinuing due to lack of efficacy.
|
0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose
|
Cumulative Percentage of Participants With Meaningful Relief
Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose
|
Percentage of participants with meaningful relief was reported.
Participants evaluated time to meaningful relief by stopping a second stopwatch labeled "meaningful relief" at the moment they first began to experience meaningful relief.
Stopwatch was active up to 12 hours after dosing or until stopped by participant, or participant became treatment failure prior to depressing the second stopwatch.
Treatment failure was defined as participant taking rescue medication, or discontinuing due to lack of efficacy.
|
0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose
|
Participant's Global Evaluation of Study Medication
Time Frame: 0 to 12 hours post-dose
|
Participant global evaluation of study medication was performed at the 12-hour time point or immediately before taking the rescue medication.
It was scored on a 6-point categorical scale where 0= Very poor, 1= Poor, 2= Fair, 3= Good, 4= Very Good and 5= Excellent.
|
0 to 12 hours post-dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2015
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
January 7, 2016
First Submitted That Met QC Criteria
September 20, 2016
First Posted (Estimate)
September 23, 2016
Study Record Updates
Last Update Posted (Actual)
August 30, 2017
Last Update Submitted That Met QC Criteria
July 28, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Antipyretics
- Acetaminophen
- Ibuprofen
Other Study ID Numbers
- B5061003
- GEMINI SDDP (Other Identifier: Alias Study Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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