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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

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Neuralgia
Intervention Drug: Pregabalin (Lyrica) capsule
Enrollment 3827
Recruitment Details  
Pre-assignment Details  
Arm/Group Title LYRICA Capsules (Pregabalin)
Hide Arm/Group Description Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 13 weeks at maximum. The dosage can be adjusted as per physician’s discretion.
Period Title: Overall Study
Started 3827
Completed 3613 [1]
Not Completed 214
Reason Not Completed
Protocol Violation             26
No Drug Administration Information             2
No Visit After Treatment             186
[1]
Number of participants whose survey form were collected and included in analyses is shown.
Arm/Group Title LYRICA Capsules (Pregabalin)
Hide Arm/Group Description Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 13 weeks at maximum. The dosage can be adjusted as per physician’s discretion.
Overall Number of Baseline Participants 3613
Hide Baseline Analysis Population Description
Among 3827 participants whose survey form was collected, a total of 214 participants were excluded from the baseline analysis population due to following reasons: protocol violation (26 participants), no drug administration information (2 participants), and no visit after treatment (186 participants).
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3613 participants
<15 years 3
≥15 and <65 years 1330
≥65 years 2280
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3613 participants
Male 1684
Female 1929
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Race and Ethnicity Not Collected Number Analyzed 3613 participants
3613
1.Primary Outcome
Title Percentage of Participants With Adverse Drug Reaction
Hide Description 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.
Time Frame 13 weeks at maximum
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once.
Arm/Group Title LYRICA Capsules (Pregabalin)
Hide Arm/Group Description:
Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 13 weeks at maximum. The dosage can be adjusted as per physician’s discretion.
Overall Number of Participants Analyzed 3613
Measure Type: Number
Unit of Measure: Percentage of Participants
15.03
2.Secondary Outcome
Title Percentage of Participants With Serious Adverse Drug Reaction
Hide Description 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.
Time Frame 13 weeks at maximum
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once.
Arm/Group Title LYRICA Capsules (Pregabalin)
Hide Arm/Group Description:
Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 13 weeks at maximum. The dosage can be adjusted as per physician’s discretion.
Overall Number of Participants Analyzed 3613
Measure Type: Number
Unit of Measure: Percentage of Participants
0.61
3.Secondary Outcome
Title The Percentage of Participants With Adverse Drug Reaction Unexpected From Japanese Package Insert
Hide Description 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.
Time Frame 13 weeks at maximum
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once.
Arm/Group Title LYRICA Capsules (Pregabalin)
Hide Arm/Group Description:
Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 13 weeks at maximum. The dosage can be adjusted as per physician’s discretion.
Overall Number of Participants Analyzed 3613
Measure Type: Number
Unit of Measure: Percentage of Participants
0.42
4.Secondary Outcome
Title Number of Participants With Adverse Drug Reactions Related to Peripheral Edema or Other Edema-related Events
Hide Description 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.
Time Frame 13 weeks at maximum
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once.
Arm/Group Title LYRICA Capsules (Pregabalin)
Hide Arm/Group Description:
Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 13 weeks at maximum. The dosage can be adjusted as per physician’s discretion.
Overall Number of Participants Analyzed 3613
Measure Type: Number
Unit of Measure: Participants
53
5.Secondary Outcome
Title Number of Participants With Adverse Drug Reactions Related to Dizziness, Somnolence, Loss of Consciousness, Syncope, and Potential for Accidental Injury
Hide Description 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.
Time Frame 13 weeks at maximum
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once.
Arm/Group Title LYRICA Capsules (Pregabalin)
Hide Arm/Group Description:
Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 13 weeks at maximum. The dosage can be adjusted as per physician’s discretion.
Overall Number of Participants Analyzed 3613
Measure Type: Number
Unit of Measure: Participants
351
6.Secondary Outcome
Title Number of Participants With Adverse Drug Reactions Related to Vision-related Events
Hide Description 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.
Time Frame 13 weeks at maximum
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once.
Arm/Group Title LYRICA Capsules (Pregabalin)
Hide Arm/Group Description:
Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 13 weeks at maximum. The dosage can be adjusted as per physician’s discretion.
Overall Number of Participants Analyzed 3613
Measure Type: Number
Unit of Measure: Participants
16
7.Secondary Outcome
Title Clinical Effectiveness Rate
Hide Description 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.
Time Frame At Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of clinical effectiveness was available and who satisfied the inclusion criteria among the baseline analysis population. Of these, participants evaluated as “impossible to judge” were excluded from the analysis population.
Arm/Group Title LYRICA Capsules (Pregabalin)
Hide Arm/Group Description:
Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 13 weeks at maximum. The dosage can be adjusted as per physician’s discretion.
Overall Number of Participants Analyzed 3567
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
84.1
(82.8 to 85.3)
8.Secondary Outcome
Title Change From Baseline in Participant-rated Pain Score at Week 13
Hide Description 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.
Time Frame Baseline and at Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of participant-rated pain score was available and who satisfied the inclusion criteria among the baseline analysis population.
Arm/Group Title LYRICA Capsules (Pregabalin)
Hide Arm/Group Description:
Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 13 weeks at maximum. The dosage can be adjusted as per physician’s discretion.
Overall Number of Participants Analyzed 1843
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-3.4  (2.61)
9.Secondary Outcome
Title Change From Baseline in Participant-rated Sleep Interference Score at Week 13
Hide Description 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.
Time Frame Baseline and at Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of participant-rated sleep interference score was available and who satisfied the inclusion criteria among the baseline analysis population.
Arm/Group Title LYRICA Capsules (Pregabalin)
Hide Arm/Group Description:
Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 13 weeks at maximum. The dosage can be adjusted as per physician’s discretion.
Overall Number of Participants Analyzed 1550
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-2.4  (2.90)
10.Secondary Outcome
Title Patient's Impression (PGIC) at Week 13
Hide Description 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.
Time Frame At Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of PGIC was available and who satisfied the inclusion criteria among the baseline analysis population.
Arm/Group Title LYRICA Capsules (Pregabalin)
Hide Arm/Group Description:
Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 13 weeks at maximum. The dosage can be adjusted as per physician’s discretion.
Overall Number of Participants Analyzed 3567
Measure Type: Number
Unit of Measure: Participants
Markedly improved 583
Improved 1039
Slightly improved 708
Unchanged 454
Slightly worsened 12
Worsened 11
Markedly worsened 1
Not assessed 759
11.Secondary Outcome
Title Physician's Impression (CGIC) at Week 13
Hide Description 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.
Time Frame At Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of CGIC was available and who satisfied the inclusion criteria among the baseline analysis population.
Arm/Group Title LYRICA Capsules (Pregabalin)
Hide Arm/Group Description:
Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 13 weeks at maximum. The dosage can be adjusted as per physician’s discretion.
Overall Number of Participants Analyzed 3567
Measure Type: Number
Unit of Measure: Participants
Markedly improved 626
Improved 1149
Slightly improved 773
Unchanged 471
Slightly worsened 9
Worsened 6
Markedly worsened 1
Not assessed 532
Time Frame 13 weeks at maximum
Adverse Event Reporting Description The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
 
Arm/Group Title LYRICA Capsules (Pregabalin)
Hide Arm/Group Description Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 13 weeks at maximum. The dosage can be adjusted as per physician’s discretion.
All-Cause Mortality
LYRICA Capsules (Pregabalin)
Affected / at Risk (%)
Total   17/3613 (0.47%) 
Show Serious Adverse Events Hide Serious Adverse Events
LYRICA Capsules (Pregabalin)
Affected / at Risk (%)
Total   77/3613 (2.13%) 
Blood and lymphatic system disorders   
Disseminated intravascular coagulation * 1  1/3613 (0.03%) 
Cardiac disorders   
Acute myocardial infarction * 1  1/3613 (0.03%) 
Angina unstable * 1  2/3613 (0.06%) 
Arrhythmia * 1  1/3613 (0.03%) 
Eye disorders   
Conjunctival haemorrhage * 1  1/3613 (0.03%) 
Eyelid oedema * 1  1/3613 (0.03%) 
Retinal detachment * 1  1/3613 (0.03%) 
Gastrointestinal disorders   
Anorectal disorder * 1  1/3613 (0.03%) 
Dysphagia * 1  1/3613 (0.03%) 
Gastrointestinal perforation * 1  1/3613 (0.03%) 
Ileus paralytic * 1  1/3613 (0.03%) 
Rectal haemorrhage * 1  1/3613 (0.03%) 
General disorders   
Condition aggravated * 1  1/3613 (0.03%) 
Death * 1  1/3613 (0.03%) 
Disease progression * 1  7/3613 (0.19%) 
Drug interaction * 1  1/3613 (0.03%) 
Generalised oedema * 1  1/3613 (0.03%) 
Oedema peripheral * 1  1/3613 (0.03%) 
Oedema * 1  2/3613 (0.06%) 
Hepatobiliary disorders   
Liver disorder * 1  1/3613 (0.03%) 
Immune system disorders   
Decreased immune responsiveness * 1  1/3613 (0.03%) 
Infections and infestations   
Gangrene * 1  1/3613 (0.03%) 
Herpes virus infection * 1  1/3613 (0.03%) 
Herpes zoster oticus * 1  1/3613 (0.03%) 
Lung infection * 1  1/3613 (0.03%) 
Lymphangitis * 1  1/3613 (0.03%) 
Pneumonia * 1  6/3613 (0.17%) 
Septic shock * 1  1/3613 (0.03%) 
Injury, poisoning and procedural complications   
Contusion * 1  1/3613 (0.03%) 
Fall * 1  4/3613 (0.11%) 
Femur fracture * 1  2/3613 (0.06%) 
Humerus fracture * 1  1/3613 (0.03%) 
Spinal compression fracture * 1  3/3613 (0.08%) 
Thermal burn * 1  1/3613 (0.03%) 
Metabolism and nutrition disorders   
Decreased appetite * 1  1/3613 (0.03%) 
Hyperkalaemia * 1  1/3613 (0.03%) 
Hyponatraemia * 1  1/3613 (0.03%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Bile duct cancer * 1  1/3613 (0.03%) 
Gastric cancer * 1  2/3613 (0.06%) 
Lung neoplasm malignant * 1  5/3613 (0.14%) 
Neoplasm malignant * 1  1/3613 (0.03%) 
Oesophageal carcinoma * 1  2/3613 (0.06%) 
Rectal cancer * 1  1/3613 (0.03%) 
Nervous system disorders   
Altered state of consciousness * 1  1/3613 (0.03%) 
Carotid artery stenosis * 1  1/3613 (0.03%) 
Cerebral haemorrhage * 1  1/3613 (0.03%) 
Cerebral infarction * 1  1/3613 (0.03%) 
Cerebrovascular accident * 1  1/3613 (0.03%) 
Depressed level of consciousness * 1  1/3613 (0.03%) 
Dizziness * 1  11/3613 (0.30%) 
Haemorrhagic cerebral infarction * 1  1/3613 (0.03%) 
Loss of consciousness * 1  1/3613 (0.03%) 
Paraparesis * 1  1/3613 (0.03%) 
Radiculopathy * 1  1/3613 (0.03%) 
Somnolence * 1  3/3613 (0.08%) 
Product Issues   
Device breakage * 1  1/3613 (0.03%) 
Psychiatric disorders   
Hallucination * 1  1/3613 (0.03%) 
Hallucination, auditory * 1  1/3613 (0.03%) 
Somatic symptom disorder * 1  1/3613 (0.03%) 
Suicide attempt * 1  1/3613 (0.03%) 
Renal and urinary disorders   
Bladder disorder * 1  1/3613 (0.03%) 
Dysuria * 1  1/3613 (0.03%) 
Renal failure * 1  2/3613 (0.06%) 
Renal impairment * 1  1/3613 (0.03%) 
Urinary retention * 1  1/3613 (0.03%) 
Respiratory, thoracic and mediastinal disorders   
Acute respiratory distress syndrome * 1  1/3613 (0.03%) 
Asthma * 1  1/3613 (0.03%) 
Chronic obstructive pulmonary disease * 1  1/3613 (0.03%) 
Haemoptysis * 1  2/3613 (0.06%) 
Respiratory disorder * 1  1/3613 (0.03%) 
Respiratory failure * 1  1/3613 (0.03%) 
Skin and subcutaneous tissue disorders   
Rash generalised * 1  1/3613 (0.03%) 
1
Term from vocabulary, MedDRA 20.0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.5%
LYRICA Capsules (Pregabalin)
Affected / at Risk (%)
Total   555/3613 (15.36%) 
Ear and labyrinth disorders   
Vertigo * 1  27/3613 (0.75%) 
Gastrointestinal disorders   
Nausea * 1  27/3613 (0.75%) 
Constipation * 1  33/3613 (0.91%) 
General disorders   
Oedema * 1  28/3613 (0.77%) 
Oedema peripheral * 1  38/3613 (1.05%) 
Investigations   
Weight increased * 1  19/3613 (0.53%) 
Nervous system disorders   
Somnolence * 1  137/3613 (3.79%) 
Dizziness * 1  246/3613 (6.81%) 
1
Term from vocabulary, MedDRA 20.0
*
Indicates events were collected by non-systematic assessment
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01256593     History of Changes
Other Study ID Numbers: A0081261
First Submitted: December 7, 2010
First Posted: December 8, 2010
Results First Submitted: July 23, 2018
Results First Posted: May 7, 2019
Last Update Posted: May 7, 2019