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Trial record 1 of 1 for:    NCT01256593
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Safety And Efficacy Of Lyrica (Regulatory Post Marketing Commitment Plan) (RAINBOW)

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ClinicalTrials.gov Identifier: NCT01256593
Recruitment Status : Completed
First Posted : December 8, 2010
Results First Posted : May 7, 2019
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date December 7, 2010
First Posted Date December 8, 2010
Results First Submitted Date July 23, 2018
Results First Posted Date May 7, 2019
Last Update Posted Date May 7, 2019
Actual Study Start Date February 2011
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 30, 2019)
Percentage of Participants With Adverse Drug Reaction [ Time Frame: 13 weeks at maximum ]
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician.
Original Primary Outcome Measures
 (submitted: December 7, 2010)
  • The incidence of adverse drug reactions. [ Time Frame: 13 weeks ]
  • Adverse drug reaction not expected from the LPD (unknown adverse drug reaction). [ Time Frame: 13 weeks ]
  • Efficacy rate for the patients of NEUROPATHIC PAIN include POSTHERPETIC NEURALGIA. [ Time Frame: 13 weeks ]
Change History Complete list of historical versions of study NCT01256593 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 30, 2019)
  • Percentage of Participants With Serious Adverse Drug Reaction [ Time Frame: 13 weeks at maximum ]
    An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to LYRICA Capsules was assessed by the physician.
  • The Percentage of Participants With Adverse Drug Reaction Unexpected From Japanese Package Insert [ Time Frame: 13 weeks at maximum ]
    An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to LYRICA Capsules was assessed by the physician.
  • Number of Participants With Adverse Drug Reactions Related to Peripheral Edema or Other Edema-related Events [ Time Frame: 13 weeks at maximum ]
    An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician. Occurrence of ADRs related to peripheral edema or other edema-related events was evaluated.
  • Number of Participants With Adverse Drug Reactions Related to Dizziness, Somnolence, Loss of Consciousness, Syncope, and Potential for Accidental Injury [ Time Frame: 13 weeks at maximum ]
    An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician. Occurrence of ADRs related to dizziness, somnolence, loss of consciousness, syncope, and potential for accidental injury was evaluated.
  • Number of Participants With Adverse Drug Reactions Related to Vision-related Events [ Time Frame: 13 weeks at maximum ]
    An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician. Occurrence of ADRs related to vision-related events was evaluated.
  • Clinical Effectiveness Rate [ Time Frame: At Week 13 ]
    Clinical effectiveness of LYRICA Capsules was determined by the physician based on the following categories: (1) effective, (2) ineffective, or (3) impossible to judge at Week 13 of the treatment. Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of the analysis population, was presented along with the corresponding 2-sided 95% CI. For the participants who completed or discontinued the treatment before Week 13, the data at the time of the completion or discontinuation was used for the analysis.
  • Change From Baseline in Participant-rated Pain Score at Week 13 [ Time Frame: Baseline and at Week 13 ]
    The pain experienced at Week 13 during the past 24 hours was rated by participants at the time of getting up in the morning on an 11-grade scale, ranging from 0 (no pain) to 10 (the most severe pain possible). Mean change from baseline in participant-rated pain score at Week 13 was presented along with standard deviation. For the participants who completed or discontinued the treatment before Week 13, the data at the time of the completion or discontinuation was used for the analysis.
  • Change From Baseline in Participant-rated Sleep Interference Score at Week 13 [ Time Frame: Baseline and at Week 13 ]
    The sleep interference (inability to sleep because of pain) experienced at Week 13 during the past 24 hours was rated by participants at the time of getting up in the morning on an 11-grade scale, ranging from 0 (no disturbance) to 10 (totally unable to sleep because of pain). Mean change from baseline in participant-rated sleep interference score at Week 13 was presented along with standard deviation. For the participants who completed or discontinued the treatment before Week 13, the data at the time of the completion or discontinuation was used for the analysis.
  • Patient's Impression (PGIC) at Week 13 [ Time Frame: At Week 13 ]
    The patient's impression (patient global impression of change [PGIC]) at Week 13, as compared to the baseline condition (including the first day of treatment), was rated by participants on a 7-grade scale. For the participants who completed or discontinued the treatment before Week 13, the data at the time of the completion or discontinuation was used for the analysis.
  • Physician's Impression (CGIC) at Week 13 [ Time Frame: At Week 13 ]
    The physician's impression (clinical global impression of change [CGIC]) at Week 13, as compared to the baseline condition (including the first day of treatment), was rated by the physician on a 7-grade scale. For the participants who completed or discontinued the treatment before Week 13, the data at the time of the completion or discontinuation was used for the analysis.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Safety And Efficacy Of Lyrica (Regulatory Post Marketing Commitment Plan)
Official Title DRUG USE INVESTIGATION OF LYRICA(REGULATORY POST MARKETING COMMITMENT PLAN)
Brief Summary The objective of this Investigation is to evaluate the safety and efficacy of Lyrica in medical practice. Also, occurrence of unknown and known adverse drug reactions (ADRs) in subjects treated with Lyrica will be monitored during the survey period, and whether an additional treatment outcome investigation and/or a post-marketing clinical study is required in the future will be determined.
Detailed Description All the patients whom an investigator prescribes the first Lyrica® should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The patients whom an investigator involving A0081261 prescribes the Lyrica capsule.
Condition Neuralgia
Intervention Drug: Pregabalin (Lyrica) capsule
Lyrica® Capsules depending on the investigator prescription. Frequency and duration are according to Package Insert as follows. "The usual adult dosage for oral use begins at 150 mg/day of pregabalin in twice daily, and should be gradually increased to 300 mg/day over 1 week or more and should be orally administered twice daily. Dosage should be adjusted, depending on age or symptoms. However, the daily maximum dose should not be beyond 600 mg, and should be orally administered twice daily".
Other Name: Lyrica® Capsules 25 mg, Lyrica® Capsules 75 mg, Lyrica® Capsules 150 mg
Study Groups/Cohorts Pregabalin (Lyrica) capsule
Patients administered "Pregabalin capsule".
Intervention: Drug: Pregabalin (Lyrica) capsule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 13, 2017)
3827
Original Estimated Enrollment
 (submitted: December 7, 2010)
3000
Actual Study Completion Date July 2017
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients need to be administered Lyrica® in order to be enrolled in the surveillance.

Exclusion Criteria:

  • Patients not administered Lyrica®.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01256593
Other Study ID Numbers A0081261
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2019