Trial Outcomes & Findings for A Study to Investigate the Effects of a New Treatment in Patients With Chronic Pain (NCT NCT02301169)

NCT ID: NCT02301169

Last Updated: 2017-12-28

Results Overview

11-point Numeric Rating Scale (NRS). Scale from 0 to 10, 0 meaning no pain, 10 pain as bad as you can imagine. Lower values represent a better outcome. Unit: arithmetic average of 7 days of a 11-point NRS

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 42 participants
• Primary outcome timeframe: Time zero equals baseline (Day 1) up to Day 42
• Results posted on: 2017-12-28

Participant Flow

Participant milestones

Measure	T4P1001 Heat pain stimuli A Video A Administration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic	Placebo Heat pain stimuli B Video B Administration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic
Overall Study STARTED	21	21
Overall Study COMPLETED	20	21
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	T4P1001 Heat pain stimuli A Video A Administration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic	Placebo Heat pain stimuli B Video B Administration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic
Overall Study Adverse Event	1	0

Baseline Characteristics

A Study to Investigate the Effects of a New Treatment in Patients With Chronic Pain

Baseline characteristics by cohort

Measure	T4P1001 n=21 Participants Heat pain stimuli A Video A Administration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic	Placebo n=21 Participants Heat pain stimuli B Video B Administration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic	Total n=42 Participants Total of all reporting groups
Age, Continuous	58 years STANDARD_DEVIATION 10.3 • n=5 Participants	55.5 years STANDARD_DEVIATION 12.7 • n=7 Participants	56.8 years STANDARD_DEVIATION 11.5 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants

PRIMARY outcome

Timeframe: Time zero equals baseline (Day 1) up to Day 42

11-point Numeric Rating Scale (NRS). Scale from 0 to 10, 0 meaning no pain, 10 pain as bad as you can imagine. Lower values represent a better outcome. Unit: arithmetic average of 7 days of a 11-point NRS

Outcome measures

Measure	T4P1001 n=20 Participants Heat pain stimuli A Video A Administration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic	Placebo n=21 Participants Heat pain stimuli B Video B Administration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic
Patient 's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Daily Average Pain Scores (APS) During 4 Weeks of Treatment	0.87 units on a scale Standard Deviation 1.49	0.5 units on a scale Standard Deviation 1.43

SECONDARY outcome

Timeframe: Time zero equals baseline (Day 1) up to Day 42

11-point Numeric Rating Scale (NRS) Scale from 0 to 10, 0 meaning no pain, 10 pain as bad as you can imagine. Lower values represent a better outcome. Unit: arithmetic average of 7 days of a 11-point NRS

Outcome measures

Measure	T4P1001 n=20 Participants Heat pain stimuli A Video A Administration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic	Placebo n=21 Participants Heat pain stimuli B Video B Administration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic
Patient 's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Daily Worst Pain Scores (WPS)	0.78 units on a scale Standard Deviation 1.45	0.65 units on a scale Standard Deviation 1.53

SECONDARY outcome

Timeframe: Time zero equals baseline (Day 1) up to Day 28

IGAC is an investigator subjective evaluation of patient condition using a NRS from 0 to 10 with 0 meaning best and 10 worst Lower values represent a better outcome.

Outcome measures

Measure	T4P1001 n=20 Participants Heat pain stimuli A Video A Administration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic	Placebo n=21 Participants Heat pain stimuli B Video B Administration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic
Patient's Change From Baseline of Investigator Global Assessment of Change (IGAC)	-0.15 units on a scale Standard Deviation 1.755	-0.95 units on a scale Standard Deviation 2.459

SECONDARY outcome

Timeframe: Time zero equals baseline (Day 1) up to Day 28

11-point Numeric Rating Scale (NRS) from 0 to 10; 0 meaning no pain, 10 pain as bad as you can imagine Lower values represent a better outcome Unit: arithmetic average on 6 reported scores per Visit.

Outcome measures

Measure	T4P1001 n=20 Participants Heat pain stimuli A Video A Administration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic	Placebo n=21 Participants Heat pain stimuli B Video B Administration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic
Patient's Change of Pain Intensity After Heat Pain Stimuli From Baseline to End of Treatment Period	0.76 units on a scale Standard Deviation 1.003	-0.01 units on a scale Standard Deviation 1.502

SECONDARY outcome

Timeframe: Time zero equals baseline (Day 1) up to Day 28

Arithmetic average of 3 questions on an 11-point Numeric Rating Scale (NRS) from 0 to 10, 0 meaning no pain, 10 pain as bad as you can imagine.

Lower values represent a better outcome

Outcome measures

Measure	T4P1001 n=20 Participants Heat pain stimuli A Video A Administration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic	Placebo n=21 Participants Heat pain stimuli B Video B Administration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic
Patient 's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Brief Pain Inventory (BPI).	3.35 units on a scale Standard Deviation 5.422	1.67 units on a scale Standard Deviation 5.704

Adverse Events

T4P1001

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	T4P1001 n=21 participants at risk Heat pain stimuli A Video A Administration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic	Placebo n=21 participants at risk Heat pain stimuli B Video B Administration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic
Nervous system disorders Migraine	4.8% 1/21	14.3% 3/21
Nervous system disorders Headache	19.0% 4/21	14.3% 3/21
Musculoskeletal and connective tissue disorders Cervical pain	9.5% 2/21	0.00% 0/21

Additional Information

Stephanie Alvarez

Tools4Patient

Phone: +32 71 14

Email: stephanie.alvarez@tools4patient.com

Results disclosure agreements

• Principal investigator is a sponsor employee Specific agreement as part of Eureka project
• Publication restrictions are in place

Restriction type: OTHER