Trial · NCT01603394
Pilot Study Of Pregabalin And Prediction Of Treatment Response In Patients With Postherpetic Neuralgia
NCT01603394, Phase 4, Terminated, Pfizer; results first posted 2014-07-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pilot Study Of Pregabalin And Prediction Of Treatment Response In Patients With Postherpetic Neuralgia. Trials, record NCT01603394. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01603394
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pilot Study Of Pregabalin And Prediction Of Treatment Response In Patients With Postherpetic Neuralgia
- NCT number
- NCT01603394
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 9 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Postherpetic Neuralgia
- Interventions
- pregabalin
- First posted
- 2012-05-22
- Last updated
- 2014-07-08
- Results first posted
- 2014-07-08
- Limitations and caveats
Outcome measure PCS was removed in protocol amendment1. Study stopped due to low enrolment and not safety. Efficacy analyses were not performed; safety results are described. Overall risk-benefit of pregabalin has not changed due to trial termination
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in the Daily Pain Diary (Numerical Rating Scale, NRS) Mean Pain Score at the End of the Study (Week 6). | Baseline, Week 6 | The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain. |
| Secondary | Neuropathic Pain Symptom Inventory (NPSI) at All Visits. | All visits | NPSI: participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning \[superficial\] spontaneous pain, pressing \[deep\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia \[P/D\]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain. |
| Secondary | Proportion of Phenotypes Within the 30% and 50% Responder Groups at Baseline and Week 6. | Baseline, Week 6 | To explore whether sensory symptom cluster analysis is useful for predicting treatment response in paticipants with PHN, identification of the phenotype was initially required of all participants using three different approaches (with or without the baseline PHQ-8, GAD-7 Pain Related Sleep Interference Score Scale, PCS): 1. PainDETECT at baseline, 2. PainPREDICT at baseline, 3. NPSI at baseline. Then for each of the above phenotypes the distribution of the pregabalin responders (using 30% and 50%) were to be compared. |
| Secondary | Patient Global Impression of Change (PGIC) at Week 6/Early Termination. | Week 6/Early Termination | PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). |
| Secondary | Proportions of Participants With >/=30% and >/=50% Pain Reduction Based on Daily Pain Diary at Baseline and Week 6. | Baseline, Week 6 | The daily pain diary consists of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants describe their pain during the previous 24 hours by choosing the appropriate number between 0 and 10. Self-assessment is performed daily at bedtime on a telephone via interactive voice response system (IVRS). The endpoint mean pain score is defined as the mean of the last 7 daily diary pain ratings while taking study medication in the open-label phase. Daily pain IVRS diaries were completed daily at bedtime from Visit 1 (Screening) through Visit 7/Early Termination. Participants were asked to complete their first IVRS daily at bedtime on the morning after Visit 1. |
| Secondary | Proportion of Participants Within Each Phenotype Group as Determined by Sensory Symptom Clustering Using the PainPREDICT, PainDETECT and Neuropathic Pain Symptom Inventory at Baseline and Week 6. | Baseline, Week 6 | To explore whether sensory symptom cluster analysis is useful for predicting treatment response in paticipants with PHN, identification of the phenotype was initially required of all participants using three different approaches (with or without the baseline PHQ-8, GAD-7 Pain Related Sleep Interference Score Scale, PCS): 1. PainDETECT at baseline, 2. PainPREDICT at baseline, 3. NPSI at baseline. |
| Secondary | Patient Health Questionnaire-8 (PHQ-8) at Baseline and Week 6; Generalized Anxiety Disorder-7 (GAD-7) at Screening, Visit 2 (Week 0) and Week 6/Early Termination. | Screening, Visit 2 (Week 0) and Week 6/Early Termination | The PHQ-8 is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as 0 (not at all) to 3 (nearly every day). The PHQ-8 is a validated subset of the PHQ-9, which comprises the first 8 items of the measure. The GAD-7 is a 7-item questionnaire that assesses anxiety. Participants respond as to how each item applies to them on a 4 point response scale. The higher the score, the more severe the anxiety. |
| Secondary | Brief Pain Inventory (BPI sf) at Visit 2 (Week 0) and Week 6. | Visit 2 (Week 0), Week 6 | The Brief Pain Inventory-Short Form (BPI-sf) consists of 5 questions. Questions 1, 2, 3, and 4 measure pain on an 11-point scale from 0 (no pain) to 10 (worst pain possible). |
| Secondary | Patient Catastrophizing Scale (PCS) at Visit 2 (Week 0) and Week 6. | Visit 2 (Week 0), Week 6 | The PCS is a 13-item self report instrument and requires a Grade 6 reading level and has been translated into 12 languages. It instructs participants to reflect on past experience of pain and indicate their experience using a 5-point scale. The PCS was designed for research on catastrophizing and pain experience. Catastrophizing is associated with heightened pain and is "an exaggerated negative mental set brought to bear during actual or anticipated painful experience." It is a multidimensional construct compromising elements of rumination, magnification, and helplessness and its factor structure has been replicated. It has a total score and three subscale scores (score range of 0-52). |
| Secondary | Pain NRS Score; 1 Week Recall Period. | 1 Week | The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in the Daily Pain Diary (Numerical Rating Scale, NRS) Mean Pain Score at the End of the Study (Week 6). | Baseline, Week 6 | Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study. | ||
| SECONDARY | Neuropathic Pain Symptom Inventory (NPSI) at All Visits. | All visits | Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study. | ||
| SECONDARY | Proportion of Phenotypes Within the 30% and 50% Responder Groups at Baseline and Week 6. | Baseline, Week 6 | Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study. | ||
| SECONDARY | Patient Global Impression of Change (PGIC) at Week 6/Early Termination. | Week 6/Early Termination | Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study. | ||
| SECONDARY | Proportions of Participants With >/=30% and >/=50% Pain Reduction Based on Daily Pain Diary at Baseline and Week 6. | Baseline, Week 6 | Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study. | ||
| SECONDARY | Proportion of Participants Within Each Phenotype Group as Determined by Sensory Symptom Clustering Using the PainPREDICT, PainDETECT and Neuropathic Pain Symptom Inventory at Baseline and Week 6. | Baseline, Week 6 | Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study. | ||
| SECONDARY | Patient Health Questionnaire-8 (PHQ-8) at Baseline and Week 6; Generalized Anxiety Disorder-7 (GAD-7) at Screening, Visit 2 (Week 0) and Week 6/Early Termination. | Screening, Visit 2 (Week 0) and Week 6/Early Termination | Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study. | ||
| SECONDARY | Brief Pain Inventory (BPI sf) at Visit 2 (Week 0) and Week 6. | Visit 2 (Week 0), Week 6 | Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study. | ||
| SECONDARY | Patient Catastrophizing Scale (PCS) at Visit 2 (Week 0) and Week 6. | Visit 2 (Week 0), Week 6 | Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study. | ||
| SECONDARY | Pain NRS Score; 1 Week Recall Period. | 1 Week | Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose) | 9 | |
| Overall Study | COMPLETED | Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose) | 8 | |
| Overall Study | NOT COMPLETED | Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose) | 1 |
Source ClinicalTrials.gov
Adverse events9
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dry mouth | Gastrointestinal disorders | Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose) | 2 | 9 | |
| other | Nausea | Gastrointestinal disorders | Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose) | 1 | 9 | |
| other | Edema peripheral | General disorders | Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose) | 2 | 9 | |
| other | Fatigue | General disorders | Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose) | 2 | 9 | |
| other | Upper respiratory tract infection | Infections and infestations | Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose) | 1 | 9 | |
| other | Muscle rigidity | Musculoskeletal and connective tissue disorders | Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose) | 1 | 9 | |
| other | Dizziness | Nervous system disorders | Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose) | 4 | 9 | |
| other | Sedation | Nervous system disorders | Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose) | 1 | 9 | |
| other | Somnolence | Nervous system disorders | Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose) | 1 | 9 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose) | ||
| Total, other adverse events | Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose) | 8 | 9 |
| Total, serious adverse events | Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose) | 0 | 9 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01603394
GET https://conductscience.org/api/trials/v1/NCT01603394/registered