PainPhase 4NCT00894790
Celecoxib Efficacy And Safety Versus Diclofenac In Acute Pain Due To Cervical Sprain Related To A Traffic Accident
A Phase 4 study testing Celecoxib and oral Diclofenac in people with Pain, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 2 sites in Mexico.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Celecoxib and oral Diclofenac
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesMexico
- Study dates
- Nov 2009to Jan 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients That Had Suffered A Car Accident And Due To It Suffered A Cervical Sprain
Who cannot join
- Recent Cervical Sprains Or Other Cervical Conditions
Trial locations and contacts
2 sites in 1 country.
Mexico2 sites
Pfizer Investigational Site
México, D.F., 04500
Pfizer Investigational Site
México, D.F., 11510
About this study
Official title: A Phase IV Open Label Randomized Multicenter Comparative Study Of Celecoxib Efficacy And Safety Versus Standard Doses Of Oral Diclofenac In Acute Pain Due To Cervical Sprain Related To Motor Vehicle Accident
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
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
celecoxib 200 mg BID (twice a day) with a loading dose of 400 mg
oral DiclofenacDrug
diclofenac 75 mg tablet BID (twice a day)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Celecoxib |
| 2 | Active comparator | Not described Receives: Drug: oral Diclofenac |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, Day 7
Secondary outcomes (8)
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).
Measured: Baseline, Days 3, 14
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.
Measured: Baseline, Days 7, 14
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).
Measured: Baseline, Days 7, 14
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).
Measured: Baseline, Days 7, 14
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.
Measured: Baseline, Days 7, 14
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).
Measured: Baseline, Days 7, 14
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).
Measured: Baseline, Days 7, 14
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.
Measured: Baseline, Days 7, 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2009 (estimated)
- Study startNov 2009
- Primary completionJan 2010
- Study completionJan 2010
Why it stopped: See termination reason in detailed description.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00894790
- Sponsor's protocol ID
- A3191352
- Status last verified
- Jan 2021
- First submitted
- 27 Mar 2009
- Last updated
- 2 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Open Label Randomized Multicenter Comparative Study Of Celecoxib Efficacy And Safety Versus Standard Doses Of Oral Diclofenac In Acute Pain Due To Cervical Sprain Related To Motor Vehicle Accident
- ClinicalTrials.gov ID
- NCT00894790
- Acronym / sponsor ID
- A3191352
- Conditions
- Pain
- Keywords
- Treatment of the acute pain due to cervical, sprain, Celecoxib, NSAID, Diclofenac
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See termination reason in detailed description.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 7 May 2009 (estimated)
- Results
- Posted 25 Feb 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Celecoxib |
| 2 | Active comparator | Drug: oral Diclofenac |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients That Had Suffered A Car Accident And Due To It Suffered A Cervical Sprain
Key exclusion criteria (1 listed)
- Recent Cervical Sprains Or Other Cervical Conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Celecoxibcelecoxib 200 mg BID (twice a day) with a loading dose of 400 mg | Drug | 1 |
| oral Diclofenacdiclofenac 75 mg tablet BID (twice a day) | Drug | 2 |
Primary outcome
Change From Baseline to Day 7 of Participant's Assessment of Cervical Pain Due to Cervical Sprain
Time frame: Baseline, Day 7
Participant rated visual analogue scale (VAS) for pain ranging from 0 to 100 mm (no pain to worst possible pain).
8 secondary outcomes
Change From Baseline on VAS-pain at Day 3 and Day 14
Time frame: Baseline, Days 3, 14
Percentage of Participants With at Least a 20 mm Improvement on VAS-pain (Responder Rates)
Time frame: Baseline, Days 7, 14
Change From Baseline in Patient Global Assessment of Cervical Injury
Time frame: Baseline, Days 7, 14
Change From Baseline on Physician's Global Assessment of Cervical Injury
Time frame: Baseline, Days 7, 14
Change From Baseline in Modified Brief Pain Inventory-Short From (m-BPI-sf): Pain Interference Score
Time frame: Baseline, Days 7, 14
Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores
Time frame: Baseline, Days 7, 14
Change From Baseline in Categorical Responses to Participant's Gastrointestinal (GI) Symptom Questionnaire
Time frame: Baseline, Days 7, 14
Change From Baseline in Participant's Responses to Neck Disability Index (NDI)
Time frame: Baseline, Days 7, 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Celecoxib and oral Diclofenac in people with Pain, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 2 sites in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Feb 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to Day 7 of Participant's Assessment of Cervical Pain Due to Cervical Sprain (time frame: Baseline, Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021.