Trial Outcomes & Findings for A Proof of Concept Study to Investigate the Effect of a New Treatment in Patient With Chronic Pain (NCT NCT02459197)

Results Overview

11-point Numeric Rating Scale (NRS); the 11 NRS scale ranges from 0 (No pain) to 10 (pain as bad as you can imagine); the baseline APS (weekly mean of the daily average pain score) was computed on the 7 last days before Visit 2 with available APS values; similarly, the end-of-treatment APS (or APS Week 4) was computed on the 7 last days before Visit 4 with available APS values.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

114 participants

Primary outcome timeframe

Time zero equals baseline (Day-28 to Day-14) up to Day 36

Results posted on

2019-08-28

Participant Flow

Participant milestones

Participant milestones
Measure	T4P1001 Heat Pain Stimuli A Positive Video Administration of T4P1001 capsules: This treatment is given as add-on therapy to patient's regular analgesic treatment	Placebo Heat Pain Stimuli B Neutral Video Administration of Placebo capsules: This treatment is given as add-on therapy to patient's regular analgesic treatment
Overall Study STARTED	58	56
Overall Study COMPLETED	58	55
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Proof of Concept Study to Investigate the Effect of a New Treatment in Patient With Chronic Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	T4P1001 n=57 Participants Heat Pain Stimuli A Positive Video Administration of T4P1001 capsules: This treatment is given as add-on therapy to patient's regular analgesic treatment	Placebo n=53 Participants Heat Pain Stimuli B Neutral Video Administration of Placebo capsules: This treatment is given as add-on therapy to patient's regular analgesic treatment	Total n=110 Participants Total of all reporting groups
Age, Continuous	59.9 years STANDARD_DEVIATION 11.2 • n=5 Participants	62.4 years STANDARD_DEVIATION 12.1 • n=7 Participants	61.1 years STANDARD_DEVIATION 11.7 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	38 Participants n=7 Participants	65 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	15 Participants n=7 Participants	45 Participants n=5 Participants

PRIMARY outcome

Timeframe: Time zero equals baseline (Day-28 to Day-14) up to Day 36

Population: 3 patients who completed the study were excluded from the Analysis Population due to protocol violations. Therefore only 110 patients were included in the Analysis Population.

11-point Numeric Rating Scale (NRS); the 11 NRS scale ranges from 0 (No pain) to 10 (pain as bad as you can imagine); the baseline APS (weekly mean of the daily average pain score) was computed on the 7 last days before Visit 2 with available APS values; similarly, the end-of-treatment APS (or APS Week 4) was computed on the 7 last days before Visit 4 with available APS values.

Outcome measures

Outcome measures
Measure	T4P1001 n=57 Participants Heat Pain Stimuli A Positive Video Administration of T4P1001 capsules: This treatment is given as add-on therapy to patient's regular analgesic treatment	Placebo n=53 Participants Heat Pain Stimuli B Neutral Video Administration of Placebo capsules: This treatment is given as add-on therapy to patient's regular analgesic treatment
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	0.54 score on a scale Standard Deviation 1.92	0.95 score on a scale Standard Deviation 1.86

SECONDARY outcome

Timeframe: Time zero equals baseline (Day-28 to Day-14) up to Day 29

Population: 3 patients who completed the study were excluded from the Analysis Population due to protocol violations. Therefore only 110 patients were included in the Analysis Population.

BPI is a self-reported scale that measures the severity of pain and the interference of pain on function (Charles S. Cleeland © 2009). In the short form of BPI, there are 4 questions assessing worst pain, least pain, actual pain and average pain in the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life. The interference scores range from 0 (does not interfere) to 10 (completely interferes).

Outcome measures

Outcome measures
Measure	T4P1001 n=56 Participants Heat Pain Stimuli A Positive Video Administration of T4P1001 capsules: This treatment is given as add-on therapy to patient's regular analgesic treatment	Placebo n=53 Participants Heat Pain Stimuli B Neutral Video Administration of Placebo capsules: This treatment is given as add-on therapy to patient's regular analgesic treatment
Patient's Change From Baseline of Pain Severity as Measured by the Brief Pain Inventory (BPI) Pain	0.98 score on a scale Standard Deviation 1.63	1.61 score on a scale Standard Deviation 1.49
Patient's Change From Baseline of Pain Severity as Measured by the Brief Pain Inventory (BPI) Interference of pain	1.09 score on a scale Standard Deviation 1.93	1.94 score on a scale Standard Deviation 1.71

SECONDARY outcome

Timeframe: Time zero equals baseline (Day-28 to Day-14) up to Day 29

Population: 3 patients who completed the study were excluded from the Analysis Population due to protocol violations. Therefore only 110 patients were included in the Analysis Population.

IGAC and PGAC are subjective evaluations using a NRS with 0 meaning "best condition" and 10 "worst condition"

Outcome measures

Outcome measures
Measure	T4P1001 n=57 Participants Heat Pain Stimuli A Positive Video Administration of T4P1001 capsules: This treatment is given as add-on therapy to patient's regular analgesic treatment	Placebo n=53 Participants Heat Pain Stimuli B Neutral Video Administration of Placebo capsules: This treatment is given as add-on therapy to patient's regular analgesic treatment
Patient's Change From Baseline of Investigator and Patient Global Assessment of Changes (IGAC and PGAC) PGAC	1.11 score on a scale Standard Deviation 2.25	2.04 score on a scale Standard Deviation 1.93
Patient's Change From Baseline of Investigator and Patient Global Assessment of Changes (IGAC and PGAC) IGAC	0.96 score on a scale Standard Deviation 1.82	1.83 score on a scale Standard Deviation 1.9

SECONDARY outcome

Timeframe: Time zero equals baseline (Day 1) up to Day 29

Population: 3 patients who completed the study were excluded from the Analysis Population due to protocol violations. Therefore only 110 patients were included in the Analysis Population.

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Outcome measures

Outcome measures
Measure	T4P1001 n=57 Participants Heat Pain Stimuli A Positive Video Administration of T4P1001 capsules: This treatment is given as add-on therapy to patient's regular analgesic treatment	Placebo n=53 Participants Heat Pain Stimuli B Neutral Video Administration of Placebo capsules: This treatment is given as add-on therapy to patient's regular analgesic treatment
Patient's Change From Baseline of Heat Pain Threshold From Baseline to End of Treatment	-0.05 °C Standard Deviation 3	-0.67 °C Standard Deviation 3.26

SECONDARY outcome

Timeframe: Time zero equals baseline (Day-28 to Day-14) up to Day 29

Population: Only OA sub-population of patients were included in the Analysis Population

The WOMAC (Bellamy et al., 1988) is a patient-rated instrument that measures OA symptoms. The questionnaire contains 5 pain questions, 2 stiffness questions, and 17 physical function questions (24 questions total). Each question utilizes a 5-points Numeric Rating Scale (NRS) between 0-4; from 0=none to 4=extreme. Range of possible subscale scores: pain=0-20, stiffness=0-8 and physical function=0-68; higher scores for each subscale indicate worse outcomes. The WOMAC was completed at each Visit except for Visit 5 by OA patients only.

Outcome measures

Outcome measures
Measure	T4P1001 n=28 Participants Heat Pain Stimuli A Positive Video Administration of T4P1001 capsules: This treatment is given as add-on therapy to patient's regular analgesic treatment	Placebo n=24 Participants Heat Pain Stimuli B Neutral Video Administration of Placebo capsules: This treatment is given as add-on therapy to patient's regular analgesic treatment
For Osteoarthritic Patients Only: Patient's Change From Baseline of Osteoarthritic Physical Function, Pain and Stiffness as Assessed by Western Ontario and MacMaster (WOMAC) Scales From Baseline to End of Treatment Pain	2.32 score on a scale Standard Deviation 3.62	4.08 score on a scale Standard Deviation 3.13
For Osteoarthritic Patients Only: Patient's Change From Baseline of Osteoarthritic Physical Function, Pain and Stiffness as Assessed by Western Ontario and MacMaster (WOMAC) Scales From Baseline to End of Treatment Stiffness	0.93 score on a scale Standard Deviation 1.59	1.67 score on a scale Standard Deviation 1.43
For Osteoarthritic Patients Only: Patient's Change From Baseline of Osteoarthritic Physical Function, Pain and Stiffness as Assessed by Western Ontario and MacMaster (WOMAC) Scales From Baseline to End of Treatment Physical function	6.71 score on a scale Standard Deviation 9.37	13.67 score on a scale Standard Deviation 11.53

Adverse Events

T4P1001

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	T4P1001 n=58 participants at risk Heat Pain Stimuli A Positive Video Administration of T4P1001 capsules: This treatment is given as add-on therapy to patient's regular analgesic treatment	Placebo n=56 participants at risk Heat Pain Stimuli B Neutral Video Administration of Placebo capsules: This treatment is given as add-on therapy to patient's regular analgesic treatment
Psychiatric disorders Affect lability	0.00% 0/58 All safety analyses included the 58 PNP patients and the 56 OA patients enrolled into the study. Of note, the PNP patient N-043 and the OA patients O-040 and O-061 completed the study and took the treatment for the entire treatment period but were identified as protocol violators due to inclusion criteria not met.	1.8% 1/56 All safety analyses included the 58 PNP patients and the 56 OA patients enrolled into the study. Of note, the PNP patient N-043 and the OA patients O-040 and O-061 completed the study and took the treatment for the entire treatment period but were identified as protocol violators due to inclusion criteria not met.

Other adverse events

Other adverse events
Measure	T4P1001 n=58 participants at risk Heat Pain Stimuli A Positive Video Administration of T4P1001 capsules: This treatment is given as add-on therapy to patient's regular analgesic treatment	Placebo n=56 participants at risk Heat Pain Stimuli B Neutral Video Administration of Placebo capsules: This treatment is given as add-on therapy to patient's regular analgesic treatment
Musculoskeletal and connective tissue disorders Arthralgia	10.3% 6/58 All safety analyses included the 58 PNP patients and the 56 OA patients enrolled into the study. Of note, the PNP patient N-043 and the OA patients O-040 and O-061 completed the study and took the treatment for the entire treatment period but were identified as protocol violators due to inclusion criteria not met.	3.6% 2/56 All safety analyses included the 58 PNP patients and the 56 OA patients enrolled into the study. Of note, the PNP patient N-043 and the OA patients O-040 and O-061 completed the study and took the treatment for the entire treatment period but were identified as protocol violators due to inclusion criteria not met.
Musculoskeletal and connective tissue disorders Back pain	6.9% 4/58 All safety analyses included the 58 PNP patients and the 56 OA patients enrolled into the study. Of note, the PNP patient N-043 and the OA patients O-040 and O-061 completed the study and took the treatment for the entire treatment period but were identified as protocol violators due to inclusion criteria not met.	10.7% 6/56 All safety analyses included the 58 PNP patients and the 56 OA patients enrolled into the study. Of note, the PNP patient N-043 and the OA patients O-040 and O-061 completed the study and took the treatment for the entire treatment period but were identified as protocol violators due to inclusion criteria not met.
Musculoskeletal and connective tissue disorders Pain in extremity	12.1% 7/58 All safety analyses included the 58 PNP patients and the 56 OA patients enrolled into the study. Of note, the PNP patient N-043 and the OA patients O-040 and O-061 completed the study and took the treatment for the entire treatment period but were identified as protocol violators due to inclusion criteria not met.	5.4% 3/56 All safety analyses included the 58 PNP patients and the 56 OA patients enrolled into the study. Of note, the PNP patient N-043 and the OA patients O-040 and O-061 completed the study and took the treatment for the entire treatment period but were identified as protocol violators due to inclusion criteria not met.
Nervous system disorders Headache	12.1% 7/58 All safety analyses included the 58 PNP patients and the 56 OA patients enrolled into the study. Of note, the PNP patient N-043 and the OA patients O-040 and O-061 completed the study and took the treatment for the entire treatment period but were identified as protocol violators due to inclusion criteria not met.	12.5% 7/56 All safety analyses included the 58 PNP patients and the 56 OA patients enrolled into the study. Of note, the PNP patient N-043 and the OA patients O-040 and O-061 completed the study and took the treatment for the entire treatment period but were identified as protocol violators due to inclusion criteria not met.
Nervous system disorders Somnolence	5.2% 3/58 All safety analyses included the 58 PNP patients and the 56 OA patients enrolled into the study. Of note, the PNP patient N-043 and the OA patients O-040 and O-061 completed the study and took the treatment for the entire treatment period but were identified as protocol violators due to inclusion criteria not met.	1.8% 1/56 All safety analyses included the 58 PNP patients and the 56 OA patients enrolled into the study. Of note, the PNP patient N-043 and the OA patients O-040 and O-061 completed the study and took the treatment for the entire treatment period but were identified as protocol violators due to inclusion criteria not met.
General disorders Fatigue	5.2% 3/58 All safety analyses included the 58 PNP patients and the 56 OA patients enrolled into the study. Of note, the PNP patient N-043 and the OA patients O-040 and O-061 completed the study and took the treatment for the entire treatment period but were identified as protocol violators due to inclusion criteria not met.	8.9% 5/56 All safety analyses included the 58 PNP patients and the 56 OA patients enrolled into the study. Of note, the PNP patient N-043 and the OA patients O-040 and O-061 completed the study and took the treatment for the entire treatment period but were identified as protocol violators due to inclusion criteria not met.
General disorders Nausea	1.7% 1/58 All safety analyses included the 58 PNP patients and the 56 OA patients enrolled into the study. Of note, the PNP patient N-043 and the OA patients O-040 and O-061 completed the study and took the treatment for the entire treatment period but were identified as protocol violators due to inclusion criteria not met.	8.9% 5/56 All safety analyses included the 58 PNP patients and the 56 OA patients enrolled into the study. Of note, the PNP patient N-043 and the OA patients O-040 and O-061 completed the study and took the treatment for the entire treatment period but were identified as protocol violators due to inclusion criteria not met.

Additional Information

Chief Scientific Officer

Tools4Patient

Phone: +32 71 91

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60