Trial Outcomes & Findings for Efficacy of Naproxen-codeine, Naproxen+Dexamethasone, and Naproxen on Myofascial Pain (NCT NCT04066426)

NCT ID: NCT04066426

Last Updated: 2021-02-15

Results Overview

Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

200 participants

Primary outcome timeframe

Pre-treatment (baseline)

Results posted on

2021-02-15

Participant Flow

Participant milestones

Participant milestones
Measure
Naproxen Sodium+Codeine Phosphate
Naproxen sodium is a propionic acid derivative with analgesic, antipyretic, and antiinflammatory properties. Its mechanism of action relies on the inhibition of prostaglandin synthesis, and significant pain relief and plasma levels can be obtained within 20 minutes following intake. The elimination half-life of naproxen sodium is reportedly around 14 hours, and naproxen sodium is used in doses ranging from 275 to 550 mg in surgical procedures. Codeine phosphate is an opioid analgesic which has similar applications to those of morphine. However, it is significantly less potent as an analgesic and has only mild sedative effects. The drug's principal site of action is at the µ-opioid receptors (MOR) which are distributed in the central nervous system. Peak effect is reached within 2 hours and analgesic action continues for approximately 4 hours. Naproxen sodium (550 mg)+codeine phosphate (30 mg) was used twice daily in this study. naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol: NSAID, steroid, opioid, paracetamol and combinations of this drugs can be used in temporomandibular disorders.
Naproxen Sodium+Dexamethasone
Naproxen sodium is a propionic acid derivative with analgesic, antipyretic, and antiinflammatory properties. Its mechanism of action relies on the inhibition of prostaglandin synthesis, and significant pain relief and plasma levels can be obtained within 20 minutes following intake. The elimination half-life of naproxen sodium is reportedly around 14 hours, and naproxen sodium is used in doses ranging from 275 to 550 mg in surgical procedures. Naproxen sodium (550 mg) was used twice daily + dexamethasone (8 mg) was used once daily in this study. naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol: NSAID, steroid, opioid, paracetamol and combinations of this drugs can be used in temporomandibular disorders.
Naproxen Sodium
Naproxen sodium is a propionic acid derivative with analgesic, antipyretic, and antiinflammatory properties. Its mechanism of action relies on the inhibition of prostaglandin synthesis, and significant pain relief and plasma levels can be obtained within 20 minutes following intake. The elimination half-life of naproxen sodium is reportedly around 14 hours, and naproxen sodium is used in doses ranging from 275 to 550 mg in surgical procedures. Naproxen sodium (550 mg) was used twice daily in this study. naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol: NSAID, steroid, opioid, paracetamol and combinations of this drugs can be used in temporomandibular disorders.
Paracetamol
Paracetamol is a mild analgesic and antipyretic, and is recommended for the treatment of most painful and febrile conditions, for example, headache including migraine, toothache, neuralgia, colds and influenza, sore throat, backache, rheumatic pain and dysmenorrhoea. naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol: NSAID, steroid, opioid, paracetamol and combinations of this drugs can be used in temporomandibular disorders.
Overall Study
STARTED
50
50
50
50
Overall Study
COMPLETED
40
40
42
47
Overall Study
NOT COMPLETED
10
10
8
3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Thirty-one patients were excluded from the study due to 26 patients having been lost to follow-up, 2 patients used different medication, and 3 patients did not comply with the intended drug dosage.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Naproxen Sodium+Codeine Phosphate
n=50 Participants
Naproxen sodium is a propionic acid derivative with analgesic, antipyretic, and antiinflammatory properties. Its mechanism of action relies on the inhibition of prostaglandin synthesis, and significant pain relief and plasma levels can be obtained within 20 minutes following intake. The elimination half-life of naproxen sodium is reportedly around 14 hours, and naproxen sodium is used in doses ranging from 275 to 550 mg in surgical procedures. Codeine phosphate is an opioid analgesic which has similar applications to those of morphine. However, it is significantly less potent as an analgesic and has only mild sedative effects. The drug's principal site of action is at the µ-opioid receptors (MOR) which are distributed in the central nervous system. Peak effect is reached within 2 hours and analgesic action continues for approximately 4 hours. Naproxen sodium (550 mg)+codeine phosphate (30 mg) was used twice daily in this study. naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol: NSAID, steroid, opioid, paracetamol and combinations of this drugs can be used in temporomandibular disorders.
Naproxen Sodium+Dexamethasone
n=50 Participants
Naproxen sodium is a propionic acid derivative with analgesic, antipyretic, and antiinflammatory properties. Its mechanism of action relies on the inhibition of prostaglandin synthesis, and significant pain relief and plasma levels can be obtained within 20 minutes following intake. The elimination half-life of naproxen sodium is reportedly around 14 hours, and naproxen sodium is used in doses ranging from 275 to 550 mg in surgical procedures. Naproxen sodium (550 mg) was used twice daily + dexamethasone (8 mg) was used once daily in this study. naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol: NSAID, steroid, opioid, paracetamol and combinations of this drugs can be used in temporomandibular disorders.
Naproxen Sodium
n=50 Participants
Naproxen sodium is a propionic acid derivative with analgesic, antipyretic, and antiinflammatory properties. Its mechanism of action relies on the inhibition of prostaglandin synthesis, and significant pain relief and plasma levels can be obtained within 20 minutes following intake. The elimination half-life of naproxen sodium is reportedly around 14 hours, and naproxen sodium is used in doses ranging from 275 to 550 mg in surgical procedures. Naproxen sodium (550 mg) was used twice daily in this study. naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol: NSAID, steroid, opioid, paracetamol and combinations of this drugs can be used in temporomandibular disorders.
Paracetamol
n=50 Participants
Paracetamol is a mild analgesic and antipyretic, and is recommended for the treatment of most painful and febrile conditions, for example, headache including migraine, toothache, neuralgia, colds and influenza, sore throat, backache, rheumatic pain and dysmenorrhoea. naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol: NSAID, steroid, opioid, paracetamol and combinations of this drugs can be used in temporomandibular disorders.
Total
n=200 Participants
Total of all reporting groups
Age, Continuous
26.18 years
STANDARD_DEVIATION 10.06 • n=40 Participants • Thirty-one patients were excluded from the study due to 26 patients having been lost to follow-up, 2 patients used different medication, and 3 patients did not comply with the intended drug dosage.
27.15 years
STANDARD_DEVIATION 10.86 • n=40 Participants • Thirty-one patients were excluded from the study due to 26 patients having been lost to follow-up, 2 patients used different medication, and 3 patients did not comply with the intended drug dosage.
29.38 years
STANDARD_DEVIATION 11.72 • n=42 Participants • Thirty-one patients were excluded from the study due to 26 patients having been lost to follow-up, 2 patients used different medication, and 3 patients did not comply with the intended drug dosage.
25.60 years
STANDARD_DEVIATION 9.57 • n=47 Participants • Thirty-one patients were excluded from the study due to 26 patients having been lost to follow-up, 2 patients used different medication, and 3 patients did not comply with the intended drug dosage.
27.04 years
STANDARD_DEVIATION 10.56 • n=169 Participants • Thirty-one patients were excluded from the study due to 26 patients having been lost to follow-up, 2 patients used different medication, and 3 patients did not comply with the intended drug dosage.
Sex: Female, Male
Female
33 Participants
n=40 Participants • Thirty-one patients were excluded from the study due to 26 patients having been lost to follow-up, 2 patients used different medication, and 3 patients did not comply with the intended drug dosage.
28 Participants
n=40 Participants • Thirty-one patients were excluded from the study due to 26 patients having been lost to follow-up, 2 patients used different medication, and 3 patients did not comply with the intended drug dosage.
36 Participants
n=42 Participants • Thirty-one patients were excluded from the study due to 26 patients having been lost to follow-up, 2 patients used different medication, and 3 patients did not comply with the intended drug dosage.
35 Participants
n=47 Participants • Thirty-one patients were excluded from the study due to 26 patients having been lost to follow-up, 2 patients used different medication, and 3 patients did not comply with the intended drug dosage.
132 Participants
n=169 Participants • Thirty-one patients were excluded from the study due to 26 patients having been lost to follow-up, 2 patients used different medication, and 3 patients did not comply with the intended drug dosage.
Sex: Female, Male
Male
7 Participants
n=40 Participants • Thirty-one patients were excluded from the study due to 26 patients having been lost to follow-up, 2 patients used different medication, and 3 patients did not comply with the intended drug dosage.
12 Participants
n=40 Participants • Thirty-one patients were excluded from the study due to 26 patients having been lost to follow-up, 2 patients used different medication, and 3 patients did not comply with the intended drug dosage.
6 Participants
n=42 Participants • Thirty-one patients were excluded from the study due to 26 patients having been lost to follow-up, 2 patients used different medication, and 3 patients did not comply with the intended drug dosage.
12 Participants
n=47 Participants • Thirty-one patients were excluded from the study due to 26 patients having been lost to follow-up, 2 patients used different medication, and 3 patients did not comply with the intended drug dosage.
37 Participants
n=169 Participants • Thirty-one patients were excluded from the study due to 26 patients having been lost to follow-up, 2 patients used different medication, and 3 patients did not comply with the intended drug dosage.
Race and Ethnicity Not Collected
0 Participants
Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Pre-treatment (baseline)

Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain)

Outcome measures

Outcome measures
Measure
Naproxen Sodium+Codeine Phosphate
n=40 Participants
Naproxen sodium is a propionic acid derivative with analgesic, antipyretic, and antiinflammatory properties. Its mechanism of action relies on the inhibition of prostaglandin synthesis, and significant pain relief and plasma levels can be obtained within 20 minutes following intake. The elimination half-life of naproxen sodium is reportedly around 14 hours, and naproxen sodium is used in doses ranging from 275 to 550 mg in surgical procedures. Codeine phosphate is an opioid analgesic which has similar applications to those of morphine. However, it is significantly less potent as an analgesic and has only mild sedative effects. The drug's principal site of action is at the µ-opioid receptors (MOR) which are distributed in the central nervous system. Peak effect is reached within 2 hours and analgesic action continues for approximately 4 hours. Naproxen sodium (550 mg)+codeine phosphate (30 mg) was used twice daily in this study. naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol: NSAID, steroid, opioid, paracetamol and combinations of this drugs can be used in temporomandibular disorders.
Naproxen Sodium+Dexamethasone
n=40 Participants
Naproxen sodium is a propionic acid derivative with analgesic, antipyretic, and antiinflammatory properties. Its mechanism of action relies on the inhibition of prostaglandin synthesis, and significant pain relief and plasma levels can be obtained within 20 minutes following intake. The elimination half-life of naproxen sodium is reportedly around 14 hours, and naproxen sodium is used in doses ranging from 275 to 550 mg in surgical procedures. Naproxen sodium (550 mg) was used twice daily + dexamethasone (8 mg) was used once daily in this study. naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol: NSAID, steroid, opioid, paracetamol and combinations of this drugs can be used in temporomandibular disorders.
Naproxen Sodium
n=42 Participants
Naproxen sodium is a propionic acid derivative with analgesic, antipyretic, and antiinflammatory properties. Its mechanism of action relies on the inhibition of prostaglandin synthesis, and significant pain relief and plasma levels can be obtained within 20 minutes following intake. The elimination half-life of naproxen sodium is reportedly around 14 hours, and naproxen sodium is used in doses ranging from 275 to 550 mg in surgical procedures. Naproxen sodium (550 mg) was used twice daily in this study. naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol: NSAID, steroid, opioid, paracetamol and combinations of this drugs can be used in temporomandibular disorders.
Paracetamol
n=47 Participants
Paracetamol is a mild analgesic and antipyretic, and is recommended for the treatment of most painful and febrile conditions, for example, headache including migraine, toothache, neuralgia, colds and influenza, sore throat, backache, rheumatic pain and dysmenorrhoea. naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol: NSAID, steroid, opioid, paracetamol and combinations of this drugs can be used in temporomandibular disorders.
Pain Evaluation
6.38 score on a scale
Standard Deviation 1.86
6.93 score on a scale
Standard Deviation 1.76
5.76 score on a scale
Standard Deviation 2.74
5.49 score on a scale
Standard Deviation 2.73

PRIMARY outcome

Timeframe: At the first week

Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain).

Outcome measures

Outcome measures
Measure
Naproxen Sodium+Codeine Phosphate
n=40 Participants
Naproxen sodium is a propionic acid derivative with analgesic, antipyretic, and antiinflammatory properties. Its mechanism of action relies on the inhibition of prostaglandin synthesis, and significant pain relief and plasma levels can be obtained within 20 minutes following intake. The elimination half-life of naproxen sodium is reportedly around 14 hours, and naproxen sodium is used in doses ranging from 275 to 550 mg in surgical procedures. Codeine phosphate is an opioid analgesic which has similar applications to those of morphine. However, it is significantly less potent as an analgesic and has only mild sedative effects. The drug's principal site of action is at the µ-opioid receptors (MOR) which are distributed in the central nervous system. Peak effect is reached within 2 hours and analgesic action continues for approximately 4 hours. Naproxen sodium (550 mg)+codeine phosphate (30 mg) was used twice daily in this study. naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol: NSAID, steroid, opioid, paracetamol and combinations of this drugs can be used in temporomandibular disorders.
Naproxen Sodium+Dexamethasone
n=40 Participants
Naproxen sodium is a propionic acid derivative with analgesic, antipyretic, and antiinflammatory properties. Its mechanism of action relies on the inhibition of prostaglandin synthesis, and significant pain relief and plasma levels can be obtained within 20 minutes following intake. The elimination half-life of naproxen sodium is reportedly around 14 hours, and naproxen sodium is used in doses ranging from 275 to 550 mg in surgical procedures. Naproxen sodium (550 mg) was used twice daily + dexamethasone (8 mg) was used once daily in this study. naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol: NSAID, steroid, opioid, paracetamol and combinations of this drugs can be used in temporomandibular disorders.
Naproxen Sodium
n=42 Participants
Naproxen sodium is a propionic acid derivative with analgesic, antipyretic, and antiinflammatory properties. Its mechanism of action relies on the inhibition of prostaglandin synthesis, and significant pain relief and plasma levels can be obtained within 20 minutes following intake. The elimination half-life of naproxen sodium is reportedly around 14 hours, and naproxen sodium is used in doses ranging from 275 to 550 mg in surgical procedures. Naproxen sodium (550 mg) was used twice daily in this study. naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol: NSAID, steroid, opioid, paracetamol and combinations of this drugs can be used in temporomandibular disorders.
Paracetamol
n=47 Participants
Paracetamol is a mild analgesic and antipyretic, and is recommended for the treatment of most painful and febrile conditions, for example, headache including migraine, toothache, neuralgia, colds and influenza, sore throat, backache, rheumatic pain and dysmenorrhoea. naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol: NSAID, steroid, opioid, paracetamol and combinations of this drugs can be used in temporomandibular disorders.
Pain Evaluation
4.68 score on a scale
Standard Deviation 1.82
5.93 score on a scale
Standard Deviation 2.22
4.95 score on a scale
Standard Deviation 2.85
4.60 score on a scale
Standard Deviation 2.89

PRIMARY outcome

Timeframe: At the second week

Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain).

Outcome measures

Outcome measures
Measure
Naproxen Sodium+Codeine Phosphate
n=40 Participants
Naproxen sodium is a propionic acid derivative with analgesic, antipyretic, and antiinflammatory properties. Its mechanism of action relies on the inhibition of prostaglandin synthesis, and significant pain relief and plasma levels can be obtained within 20 minutes following intake. The elimination half-life of naproxen sodium is reportedly around 14 hours, and naproxen sodium is used in doses ranging from 275 to 550 mg in surgical procedures. Codeine phosphate is an opioid analgesic which has similar applications to those of morphine. However, it is significantly less potent as an analgesic and has only mild sedative effects. The drug's principal site of action is at the µ-opioid receptors (MOR) which are distributed in the central nervous system. Peak effect is reached within 2 hours and analgesic action continues for approximately 4 hours. Naproxen sodium (550 mg)+codeine phosphate (30 mg) was used twice daily in this study. naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol: NSAID, steroid, opioid, paracetamol and combinations of this drugs can be used in temporomandibular disorders.
Naproxen Sodium+Dexamethasone
n=40 Participants
Naproxen sodium is a propionic acid derivative with analgesic, antipyretic, and antiinflammatory properties. Its mechanism of action relies on the inhibition of prostaglandin synthesis, and significant pain relief and plasma levels can be obtained within 20 minutes following intake. The elimination half-life of naproxen sodium is reportedly around 14 hours, and naproxen sodium is used in doses ranging from 275 to 550 mg in surgical procedures. Naproxen sodium (550 mg) was used twice daily + dexamethasone (8 mg) was used once daily in this study. naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol: NSAID, steroid, opioid, paracetamol and combinations of this drugs can be used in temporomandibular disorders.
Naproxen Sodium
n=42 Participants
Naproxen sodium is a propionic acid derivative with analgesic, antipyretic, and antiinflammatory properties. Its mechanism of action relies on the inhibition of prostaglandin synthesis, and significant pain relief and plasma levels can be obtained within 20 minutes following intake. The elimination half-life of naproxen sodium is reportedly around 14 hours, and naproxen sodium is used in doses ranging from 275 to 550 mg in surgical procedures. Naproxen sodium (550 mg) was used twice daily in this study. naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol: NSAID, steroid, opioid, paracetamol and combinations of this drugs can be used in temporomandibular disorders.
Paracetamol
n=47 Participants
Paracetamol is a mild analgesic and antipyretic, and is recommended for the treatment of most painful and febrile conditions, for example, headache including migraine, toothache, neuralgia, colds and influenza, sore throat, backache, rheumatic pain and dysmenorrhoea. naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol: NSAID, steroid, opioid, paracetamol and combinations of this drugs can be used in temporomandibular disorders.
Pain Evaluation
3.58 score on a scale
Standard Deviation 1.69
5.28 score on a scale
Standard Deviation 2.36
4.33 score on a scale
Standard Deviation 2.78
4.34 score on a scale
Standard Deviation 3.03

PRIMARY outcome

Timeframe: At the first month

Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain).

Outcome measures

Outcome measures
Measure
Naproxen Sodium+Codeine Phosphate
n=40 Participants
Naproxen sodium is a propionic acid derivative with analgesic, antipyretic, and antiinflammatory properties. Its mechanism of action relies on the inhibition of prostaglandin synthesis, and significant pain relief and plasma levels can be obtained within 20 minutes following intake. The elimination half-life of naproxen sodium is reportedly around 14 hours, and naproxen sodium is used in doses ranging from 275 to 550 mg in surgical procedures. Codeine phosphate is an opioid analgesic which has similar applications to those of morphine. However, it is significantly less potent as an analgesic and has only mild sedative effects. The drug's principal site of action is at the µ-opioid receptors (MOR) which are distributed in the central nervous system. Peak effect is reached within 2 hours and analgesic action continues for approximately 4 hours. Naproxen sodium (550 mg)+codeine phosphate (30 mg) was used twice daily in this study. naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol: NSAID, steroid, opioid, paracetamol and combinations of this drugs can be used in temporomandibular disorders.
Naproxen Sodium+Dexamethasone
n=40 Participants
Naproxen sodium is a propionic acid derivative with analgesic, antipyretic, and antiinflammatory properties. Its mechanism of action relies on the inhibition of prostaglandin synthesis, and significant pain relief and plasma levels can be obtained within 20 minutes following intake. The elimination half-life of naproxen sodium is reportedly around 14 hours, and naproxen sodium is used in doses ranging from 275 to 550 mg in surgical procedures. Naproxen sodium (550 mg) was used twice daily + dexamethasone (8 mg) was used once daily in this study. naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol: NSAID, steroid, opioid, paracetamol and combinations of this drugs can be used in temporomandibular disorders.
Naproxen Sodium
n=42 Participants
Naproxen sodium is a propionic acid derivative with analgesic, antipyretic, and antiinflammatory properties. Its mechanism of action relies on the inhibition of prostaglandin synthesis, and significant pain relief and plasma levels can be obtained within 20 minutes following intake. The elimination half-life of naproxen sodium is reportedly around 14 hours, and naproxen sodium is used in doses ranging from 275 to 550 mg in surgical procedures. Naproxen sodium (550 mg) was used twice daily in this study. naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol: NSAID, steroid, opioid, paracetamol and combinations of this drugs can be used in temporomandibular disorders.
Paracetamol
n=47 Participants
Paracetamol is a mild analgesic and antipyretic, and is recommended for the treatment of most painful and febrile conditions, for example, headache including migraine, toothache, neuralgia, colds and influenza, sore throat, backache, rheumatic pain and dysmenorrhoea. naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol: NSAID, steroid, opioid, paracetamol and combinations of this drugs can be used in temporomandibular disorders.
Pain Evaluation
2.93 score on a scale
Standard Deviation 1.65
5.28 score on a scale
Standard Deviation 2.50
3.69 score on a scale
Standard Deviation 2.71
4.38 score on a scale
Standard Deviation 2.96

Adverse Events

Naproxen Sodium+Codeine Phosphate

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

Naproxen Sodium+Dexamethasone

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

Naproxen Sodium

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

Paracetamol

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

Dr. Volkan Kaplan

Tekirdag Namik Kemal University

Phone: +90282250000

Results disclosure agreements

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