Trial Outcomes & Findings for Celecoxib Efficacy And Safety Versus Diclofenac In Acute Pain Due To Cervical Sprain Related To A Traffic Accident (NCT NCT00894790)

NCT ID: NCT00894790

Last Updated: 2021-02-02

Results Overview

Participant rated visual analogue scale (VAS) for pain ranging from 0 to 100 mm (no pain to worst possible pain).

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

8 participants

Primary outcome timeframe

Baseline, Day 7

Results posted on

2021-02-02

Participant Flow

Participant milestones

Participant milestones
Measure
Celecoxib
Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
Diclofenac
Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
Overall Study
STARTED
4
4
Overall Study
COMPLETED
3
2
Overall Study
NOT COMPLETED
1
2

Reasons for withdrawal

Reasons for withdrawal
Measure
Celecoxib
Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
Diclofenac
Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
Overall Study
Protocol Violation
0
1
Overall Study
Lost to Follow-up
0
1
Overall Study
Did not meet entrance criteria
1
0

Baseline Characteristics

Celecoxib Efficacy And Safety Versus Diclofenac In Acute Pain Due To Cervical Sprain Related To A Traffic Accident

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Celecoxib
n=4 Participants
Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
Diclofenac
n=4 Participants
Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
Total
n=8 Participants
Total of all reporting groups
Age, Customized
18 to 44 years
2 participants
n=99 Participants
2 participants
n=107 Participants
4 participants
n=206 Participants
Age, Customized
45 to 64 years
2 participants
n=99 Participants
2 participants
n=107 Participants
4 participants
n=206 Participants
Sex: Female, Male
Female
4 Participants
n=99 Participants
3 Participants
n=107 Participants
7 Participants
n=206 Participants
Sex: Female, Male
Male
0 Participants
n=99 Participants
1 Participants
n=107 Participants
1 Participants
n=206 Participants

PRIMARY outcome

Timeframe: Baseline, Day 7

Population: Data not analyzed due to study termination.

Participant rated visual analogue scale (VAS) for pain ranging from 0 to 100 mm (no pain to worst possible pain).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Days 3, 14

Population: Data not analyzed due to study termination.

Participant rated visual analogue scale (VAS) for pain ranging from 0 to 100 mm (no pain to worst possible pain).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Days 7, 14

Population: Data not analyzed due to study termination.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Days 7, 14

Population: Data not analyzed due to study termination.

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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Days 7, 14

Population: Data not analyzed due to study termination.

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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Days 7, 14

Population: Data not analyzed due to study termination.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Days 7, 14

Population: Data not analyzed due to study termination.

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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Days 7, 14

Population: Data not analyzed due to study termination.

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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Days 7, 14

Population: Data not analyzed due to study termination.

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.

Outcome measures

Outcome data not reported

Adverse Events

Celecoxib

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Diclofenac

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Results disclosure agreements

  • Principal investigator is a sponsor employee 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.
  • Publication restrictions are in place

Restriction type: OTHER