Pain
Conditions
Keywords
Treatment of the acute pain due to cervical, sprain, Celecoxib, NSAID, Diclofenac
Brief summary
This Study Will Evaluate Celecoxib Efficacy And Safety Versus Standard Doses Of Diclofenac In Acute Pain Due To Cervical Injury (Due To A Sprain) Related To A Motor Vehicle Accident
Detailed description
On 21Oct2010 study was prematurely terminated due to poor enrollment with subsequent low number of participants. No safety or efficacy issues were involved in the decision to terminate prematurely.
Interventions
DRUGCelecoxib
celecoxib 200 mg BID (twice a day) with a loading dose of 400 mg
DRUGoral Diclofenac
diclofenac 75 mg tablet BID (twice a day)
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients That Had Suffered A Car Accident And Due To It Suffered A Cervical Sprain
Exclusion criteria
* Recent Cervical Sprains Or Other Cervical Conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Day 7 of Participant's Assessment of Cervical Pain Due to Cervical Sprain | Baseline, Day 7 | Participant rated visual analogue scale (VAS) for pain ranging from 0 to 100 mm (no pain to worst possible pain). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline on VAS-pain at Day 3 and Day 14 | Baseline, Days 3, 14 | Participant rated visual analogue scale (VAS) for pain ranging from 0 to 100 mm (no pain to worst possible pain). |
| Percentage of Participants With at Least a 20 mm Improvement on VAS-pain (Responder Rates) | Baseline, Days 7, 14 | Participant rated visual analogue scale (VAS) for pain ranging from 0 to 100 mm (no pain to worst possible pain) with at least a 20 mm improvement. |
| Change From Baseline in Patient Global Assessment of Cervical Injury | Baseline, Days 7, 14 | Participant rated responses to question: Considering all the ways your cervical injury affects you, how are you doing today? Response options ranged from 1 (Very good - No symptoms and no limitation of normal activities) to 5 (Very Poor - Very severe symptoms which are intolerable and inability to carry out all normal activities). |
| Change From Baseline on Physician's Global Assessment of Cervical Injury | Baseline, Days 7, 14 | Physician rated responses evaluating the overall condition of participant's cervical injury at that time. Response option ranged from 1 (Very mild - Very mild signs and symptoms of cervical injury) to 5 (Very Severe - Very severe signs and symptoms of cervical injury). |
| Change From Baseline in Modified Brief Pain Inventory-Short From (m-BPI-sf): Pain Interference Score | Baseline, Days 7, 14 | m-BPI-sf: participant-rated 11 point Likert rating scale ranging from 0 (does not interfere) to 10 (completely intereres) with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. |
| Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores | Baseline, Days 7, 14 | m-BPI-sf: participant rated 11-point Likert rating scale ranging from 0 (no pain) to 10 (worst pain possible). Pain severity index is the mean of item scores 2, 3, and 4 (pain right now, worst pain, and average pain level). |
| Change From Baseline in Categorical Responses to Participant's Gastrointestinal (GI) Symptom Questionnaire | Baseline, Days 7, 14 | Two part questionnaire; First part assessed symptoms: feeling of gas/air in stomach or feeling bloated, nausea, vomiting, excessive burping or belching and worsening of heartburn or acid reflux. Participant rated Yes/No experienced, for how many days per week (1 through 7) for each symptom and how bothered they were (not at all, somewhat or very). Second part assessed the presence of general abdominal pain (steady, dull, sharp/shooting, always present or comes and goes), the number of days they experienced it (1 through 7) and how bothered they were by it (not at all, somewhat, very). |
| Change From Baseline in Participant's Responses to Neck Disability Index (NDI) | Baseline, Days 7, 14 | NDI: participant-administered 10-item questionnaire to assess how neck pain affects 10 activities of daily living (pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation) with six potential responses, each describing a greater degree of disability (0 = no disability to 5 = total disability). Total score calculated by adding individual item scores for evaluation scheme: 0-5 = No disability; 6-15 = Mild disability; 16-25 = Moderate disability; 26-35 = Severe disability; Above 35 = Complete disability. |
Countries
Mexico
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Celecoxib Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days | 4 |
| Diclofenac Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care | 4 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not meet entrance criteria | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Protocol Violation | 0 | 1 |
Baseline characteristics
| Characteristic | Celecoxib | Diclofenac | Total |
|---|---|---|---|
| Age, Customized 18 to 44 years | 2 participants | 2 participants | 4 participants |
| Age, Customized 45 to 64 years | 2 participants | 2 participants | 4 participants |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 4 | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 | 0 / 4 |
Outcome results
Primary
Change From Baseline to Day 7 of Participant's Assessment of Cervical Pain Due to Cervical Sprain
Participant rated visual analogue scale (VAS) for pain ranging from 0 to 100 mm (no pain to worst possible pain).
Time frame: Baseline, Day 7
Population: Data not analyzed due to study termination.
Secondary
Change From Baseline in Categorical Responses to Participant's Gastrointestinal (GI) Symptom Questionnaire
Two part questionnaire; First part assessed symptoms: feeling of gas/air in stomach or feeling bloated, nausea, vomiting, excessive burping or belching and worsening of heartburn or acid reflux. Participant rated Yes/No experienced, for how many days per week (1 through 7) for each symptom and how bothered they were (not at all, somewhat or very). Second part assessed the presence of general abdominal pain (steady, dull, sharp/shooting, always present or comes and goes), the number of days they experienced it (1 through 7) and how bothered they were by it (not at all, somewhat, very).
Time frame: Baseline, Days 7, 14
Population: Data not analyzed due to study termination.
Secondary
Change From Baseline in Modified Brief Pain Inventory-Short From (m-BPI-sf): Pain Interference Score
m-BPI-sf: participant-rated 11 point Likert rating scale ranging from 0 (does not interfere) to 10 (completely intereres) with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours.
Time frame: Baseline, Days 7, 14
Population: Data not analyzed due to study termination.
Secondary
Change From Baseline in Participant's Responses to Neck Disability Index (NDI)
NDI: participant-administered 10-item questionnaire to assess how neck pain affects 10 activities of daily living (pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation) with six potential responses, each describing a greater degree of disability (0 = no disability to 5 = total disability). Total score calculated by adding individual item scores for evaluation scheme: 0-5 = No disability; 6-15 = Mild disability; 16-25 = Moderate disability; 26-35 = Severe disability; Above 35 = Complete disability.
Time frame: Baseline, Days 7, 14
Population: Data not analyzed due to study termination.
Secondary
Change From Baseline in Patient Global Assessment of Cervical Injury
Participant rated responses to question: Considering all the ways your cervical injury affects you, how are you doing today? Response options ranged from 1 (Very good - No symptoms and no limitation of normal activities) to 5 (Very Poor - Very severe symptoms which are intolerable and inability to carry out all normal activities).
Time frame: Baseline, Days 7, 14
Population: Data not analyzed due to study termination.
Secondary
Change From Baseline on Physician's Global Assessment of Cervical Injury
Physician rated responses evaluating the overall condition of participant's cervical injury at that time. Response option ranged from 1 (Very mild - Very mild signs and symptoms of cervical injury) to 5 (Very Severe - Very severe signs and symptoms of cervical injury).
Time frame: Baseline, Days 7, 14
Population: Data not analyzed due to study termination.
Secondary
Change From Baseline on VAS-pain at Day 3 and Day 14
Participant rated visual analogue scale (VAS) for pain ranging from 0 to 100 mm (no pain to worst possible pain).
Time frame: Baseline, Days 3, 14
Population: Data not analyzed due to study termination.
Secondary
Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores
m-BPI-sf: participant rated 11-point Likert rating scale ranging from 0 (no pain) to 10 (worst pain possible). Pain severity index is the mean of item scores 2, 3, and 4 (pain right now, worst pain, and average pain level).
Time frame: Baseline, Days 7, 14
Population: Data not analyzed due to study termination.
Secondary
Percentage of Participants With at Least a 20 mm Improvement on VAS-pain (Responder Rates)
Participant rated visual analogue scale (VAS) for pain ranging from 0 to 100 mm (no pain to worst possible pain) with at least a 20 mm improvement.
Time frame: Baseline, Days 7, 14
Population: Data not analyzed due to study termination.